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Category Archives: Molecular Medicine

Worm Spitting Powered by Muscle Cells That Perform Two Actions at Once – Howard Hughes Medical Institute

Posted: August 5, 2021 at 1:59 am

Summary

When hungry worms encounter bad-tasting chemicals, they stop eating and spit. To make this switch possible, a muscle in their mouths does two different things simultaneously, splitting up its activity in a way that scientists have never seen before.

Muscle cells can multitask.

In tiny, transparent worms, one type of muscle cell can partition itself so that two areas act independently, a new study reveals. One cell region contracts while a second region undergoes rhythmic contractions and relaxations.

Scientists have generally thought that each muscle cell contractsin a uniformmotion. The collective action of constellations of muscle cells then produces the movements a creature needs to flee a predator, consume a meal, or type an email.

But Howard Hughes Medical Institute Investigator H. Robert Horvitz and colleagues discovered a division of labor within one type of worm muscle cell that allows the animal to protect itself from potentially dangerous chemicals. This multitasking cell lets the worms quickly spit out food they have swallowed, study coauthor Steven Sando, Horvitz, and their colleagues report in the journal eLife on July 2, 2021; the full version of their paper was published on August 3.

This is the first study to show that two compartments within a muscle cell can contract independently, seemingly oblivious to each other, says Horvitz, a molecular geneticist and neurobiologist at the Massachusetts Institute of Technology.

Steves discovery changes the way we think about the control of behavior, because it suggests that individual muscle cells can be partitioned into smaller functional units, adds Horvitz, who shared the 2002 Nobel Prize in Physiology or Medicine for identifying genes that control organ development and programmed cell death.

The roundworm Caenorhabditis elegans gobbles up microbes floating in the water using its tube-like mouth. Muscle cells contract to open a valve at the front of the mouth and to generate suction that pulls in water and microbes. The worms are like little vacuum cleaners for bacteria, Sando says. When the muscle cells relax, the valve closes, causing food to remain trapped in the worms mouth.

Previously, researchers in the lab had observed that when a worm senses noxious chemicals, it stops eating and spits out bubbles and food. Watching through a microscope as these worms spit, Sando noticed that they were holding the front part of their mouths, where the valve is located, open.

Using a laser, he disabled muscle cells lining the mouth and concluded that a single type of cell, called pm3, was responsible for letting the worms spit. By examining the molecular signaling within pm3, Sando showed that the front part of the cell activated independently from the rest.

Sandos results revealed that when a worm spits, the pm3 muscles perform two actions at once. At the front of pm3, a small region contracts to hold the valve open, and it stays contracted while the remaining 90 percent of the cell contracts and relaxes rhythmically to suck in water and then eject it until the worm has cleansed its palate.

In other experiments, Sando traced the key control of this activity to a single neuron. Based on information it receives from taste-sensing cells, this neuron controls whether the worm eats, spits, or performs some variation on these behaviors.

While no one has seen this type of muscle cell multitasking before, scientists already knew of a similar strategy that takes place in the worms gut, and in ours. As part of digestion, wave-like contractions ripple through cells to push food forward. What Sandos team saw was different, however: During spitting, one specific region of pm3 underwent sustained contraction, which didnt propagate to adjacent regions of pm3.

This division of labor may be a strategy that allows the worms to do more with the relatively few cells they possess, says Aravithan Samuel, a biophysicist at Harvard University who was not involved in the study. Like a human, C. elegans is a multicellular organism; however, its body is much simpler, possessing only 959 cells. Even with these limited components, the worm is capable of complex behaviors. Small creatures can do amazing things, he says.

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Citation

Steven R. Sando et al., An hourglass circuit motif transforms a motor program via subcellularly localized muscle calcium signaling and contraction. eLife. Published online July 2, 2021. doi: 10.7554/eLife.59341

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Philips Genomics Workspace enables integration of the largest-scale FDA-cleared cancer genetic test at NYU – GlobeNewswire

Posted: August 5, 2021 at 1:59 am

August 3, 2021

Amsterdam, the Netherlands Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that New York Langone Healths Department of Pathology will leverage Philips Genomics Workspace (formerly part of IntelliSpace Precision Medicine Platform) to integrate into their EMR (electronic medical record) environment. This will enable the largest cancer sequencing test in the industry, helping to guide more confident treatment decisions and care pathways for patients who have received a cancer diagnosis.

Genetic test for all cancers designed by NYU Langones molecular pathologistsCleared by the FDA (U.S. Food and Drug Administration) earlier this month under its 510(k) designation for clinical lab use, the NYU Langone Genome PACT (Profiling of Actionable Cancer Targets) test detects changes in the DNA code of 607 genes linked by past studies to the development of multiple types of cancer. The number of genes cancer types assayed is the largest among academic genomic sequencing tests of its kind.

PACT uses next-generation sequencing (NGS) technology, which can read the sequence of the molecular letters making up DNA code within hundreds of genes simultaneously, and covers the most genes of any FDA-cleared NGS test to-date. The technology matches the genetics of each patients tumor cells with a growing number of approved therapies targeted to address specific sets of cancer-causing DNA changes.

The work currently underway at NYU Langone is ground-breaking in the area of genomic sequencing and we are honored to be teaming on the development efforts, including building an interface between the new test and NYU Langone Healths electronic medical records system, said Louis Culot, General Manager of Oncology Informatics at Philips. Philips Genomics Workspace, hosted on cloud-based Philips HealthSuite, will help facilitate the integration into the EMR so tests can be seamlessly ordered, reviewed, and shared by a patients care team.

PACT reaffirms the goal behind its design, which was to provide our patients with the best understanding of the genetic changes driving their cancers, said PACT designer Matija Snuderl, MD, director of Molecular Pathology and Diagnostics in the Department of Pathology at NYU Langone Health. Knowing the genetics of their tumor can help to determine which therapies will work for a given patient and their eligibility for specific clinical trials. Beyond the genetic changes that are important to the field now, we also wanted PACT to detect the changes anticipated to be important in diagnosis and treatment of cancer over the next five to ten years.

Philips end-to-end oncology solutions driving a clear path to precision cancer careAccording to the National Cancer Institute, patients today usually receive the same treatment as others who have same type and stage of cancer, despite growing evidence that they may respond differently [1]. Philips approach to precision medicine is to arm care teams with expert clinical guidance and a holistic view of the patients genotypic (the set of genes in the DNA) and phenotypic (observable characteristics influenced by environmental and lifestyle factors) information in order to make decisions efficiently, collaboratively and accurately. Recognizing the growing need for technological advancement in oncology care from early detection to diagnosis to treatment to survivorship Philips connects areas such as pathology, genomics, molecular/multi-disciplinary tumor boards, therapy decision making, molecular and imaging phenotyping, so clinicians can have easy access to the insights they need to provide high-quality personalized care.

With Philips Genomics Workspace, oncologists can map a patients uniquecharacteristics to a therapy that is best suited for them and provide evidence on why that therapy is preferable. Philips genomics solution combines individual institution genomic knowledge bases and general industry knowledge bases, to help molecular pathologists interpret genomic data and to provide clinicians with ways to enable improved patient care. Visit Philips Precision Medicine to learn more.

[1] https://www.cancer.gov/about-cancer/treatment/types/biomarker-testing-cancer-treatment.

For further information, please contact:

Kathy OReillyPhilips Global Press OfficeTel.: + 1 978-221-8919E-mail: kathy.oreilly@philips.comTwitter: @kathyoreilly

Greg WilliamsResearch Communications DirectorNYU Grossman School of MedicineTel: +1 212-404-3500E-mail: Gregory.williams@nyulangone.org

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and well-being, and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2020 sales of EUR 17.3 billion and employs approximately 77,000 employees with sales and services in more than 100 countries. News about Philips can be found at http://www.philips.com/newscenter.

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Fluoroscopy & C Arms Market Expected to Rise at A High CAGR, Driving Robust Sales and Revenue till 2026 The Manomet Current – The Manomet Current

Posted: August 5, 2021 at 1:59 am

The finest Fluoroscopy & C Arms Marketreport gives better ideas and solutions in terms of product trends, marketing strategy, future products, new geographical markets, future events, sales strategies, customer actions or behaviors. With the precise and high-tech information about industry, businesses can know about the types of consumers, consumers demands and preferences, their perspectives about the product, their buying intentions, their response to particular product, and their varying tastes about the specific product already existing in the market through an influential Fluoroscopy & C Arms Marketreport. Here, market overview is given in terms of drivers, restraints, opportunities and challenges where each of this parameter is studied scrupulously.

The world class Fluoroscopy & C Arms Market report is generated by performing high level market research analysis of key marketplace segments to identify opportunities, challenges, drivers, and market structures for clients. This market survey report brings into focus plentiful of factors such as the general market conditions, trends, inclinations, key players, opportunities, and geographical analysis which all aids to take the business towards the growth and success. In this report, several aspects about the market research and analysis for the industry have been underlined. Fluoroscopy & C Arms Market report has been designed by keeping in mind the customer requirements which assist them in increasing their return on investment (ROI).

Global fluoroscopy and C Arms marketis expected to reach at a CAGR of 4.3% in the forecast period of 2018 to 2025.

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The digital fluoroscopy or radiographic imaging systems are used for imaging and produce visible electronic images of patients for treatment.

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Major Players:Global Fluoroscopy & C Arms Market

Some of the prominent participants operating in this market are GE Healthcare, Koninklijke Philips N.V., Siemens AG, Canon Medical Systems Corporation, Shimadzu Corporation, Carestream Health, EcoRay, Eurocolumbus s.r.l., GEMSS Co., Ltd., Hitachi, Ltd., Hologic Inc., INTERMEDICAL S.r.l., ITALYRAY, PAUSCH Medical GmbH, Varex Imaging Corporation, Whale Imaging, and Ziehm Imaging GmbH among others.

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By Fluoroscopy Type (Conventional Fluoroscopy Systems, Remote-Controlled Fluoroscopy Systems), C Arm Type (Fixed C-Arms, Mobile C-Arms), C Arm Technology (Flat Panel, Image Intensifiers), Application (Diagnostic Applications, Surgical Application, Discography), End User (Hospitals, Diagnostic Centers, Specialty Clinics), Geography (North America, Europe, Asia-Pacific, South America, Middle East and Africa) Industry Trends and Forecast to 2026

GE Healthcare:

GE Healthcare founded in 1918, headquarters in New York, U.S., and focuses towards the manufacturing and developer of medical imaging, digital solutions, patient monitoring and diagnostics, drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions.

The company has its presence in U.S, Europe, Asia, Americas, Middle East and Africa.

Koninklijke Philips N.V.:

Koninklijke Philips N.V., founded in 1891 and based in Amsterdam, Netherlands. The company focuses on improving peoples health and enabling better outcomes across the health continuum from healthy living and prevention to diagnosis, treatment and home care.

The company has its presence in Netherland, United states, China, Germany, Japan, France, India and Others.

Siemens AG:

Siemens AG, founded in 1896 and based in Munich, Germany. The company provides manufacturing, distributing and services of medical devices and pharma Services. Company is engaged in providing precision medicines, transforming care delivery, innovative technology in area of diagnostics, molecular medicine and many others. The company has its presence in Europe, C.I.S., Africa, Middle East, Americas , Asia, Australia.

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T-knife Therapeutics Announces $110 Million Series B Financing to Advance Pipeline of T-cell Receptor – GlobeNewswire

Posted: August 5, 2021 at 1:59 am

SAN FRANCISCO and BERLIN, Aug. 02, 2021 (GLOBE NEWSWIRE) -- T-knife Therapeutics, Inc., a next-generation T-cell receptor company developing a pipeline of innovative therapeutics for solid tumor patients, today announced the successful completion of a $110 million Series B financing. The financing was led by Fidelity Management & Research Company, LLC., with participation from other new investors including, LSP, Qatar Investment Authority (QIA), Casdin Capital, Sixty Degree Capital, and CaaS Capital, along with existing investors RA Capital Management, Versant Ventures and founding investor Andera Partners. The company plans to use proceeds from the financing to expand its scientific team, increase manufacturing capacity and advance its pipeline of T-cell receptor (TCR) engineered T cell therapies (TCR-T).

Over the past year we have made substantial progress toward our goal of building a leading TCR-T company focused on delivering clinically meaningful benefits for patients with solid tumors, stated Thomas M. Soloway, Chief Executive Officer of T-knife. We are excited to have the support of this group of dedicated life sciences investors to help us fulfill our mission, and we welcome Dr. Karin Kleinhans of LSP to our board of directors.

T-knife has an elegant and differentiated approach to identifying potent, cancer-specific TCRs with naturally optimized affinity and specificity profiles, creating a next-generation platform for this promising therapeutic field, said Alex Mayweg, Chairman of T-knife and Managing Director at Versant Ventures. We are pleased to be progressing TK-8001 toward the clinic and to advance our broader portfolio of product candidates.

T-knife is leveraging its proprietary HuTCR transgenic mouse platform to discover and develop a portfolio of TCR-T programs to treat patients with solid tumors. T-knifes lead program, TK-8001, is a novel TCR-T product candidate targeting MAGE-A1 positive cancers. T-knife plans to begin enrolling patients in the TK-8001 IMAG1NE Phase 1/2 clinical study in the fourth quarter of 2021 and is planning to submit INDs/CTAs for additional product candidates in 2022.

"The field of TCR-T holds significant promise to change the treatment paradigm for many cancer patients, said Karin Kleinhans, PhD, Partner at LSP who joined T-Knifes board in connection with the Series B financing. We are highly encouraged by the progress being made at T-knife to advance its important next-generation therapies.

Olivier Litzka, Partner at Andera Partners, commented, As a founding investor, it is gratifying to witness the continued success at T-knife. The completion of the Series B financing is an important milestone that will enable us to execute on our vision of building a leading transatlantic immuno-oncology company.

About the HuTCR platformT cells play a key role in the immune response by directly recognizing and eliminating infected, foreign or altered cells, such as cancer cells. To do this, they use their T-cell receptors (TCRs) to scan the surface of other cells for foreign antigens presented on Human Leukocyte Antigen (HLA) complexes. Cancer cells can be recognized by mutated or viral antigens expressed only in the tumor, or self-antigens normally expressed during embryonic development and in non-somatic adult tissues. Genetic engineering of T cells with TCRs recognizing antigens aberrantly or over-expressed in cancers can redirect these T cells to the tumor, potentially offering curative responses to cancer patients.

The ability to identify potent cancer-specific TCRs has been limiting for the field of TCR-T. In the case of self-antigens, T cells bearing those TCRs are eliminated during T cell development to avoid recognition and attack of healthy tissues. For non-self tumor antigens, such as those derived from viral sequences or mutations, the very low T cell frequency in the blood has limited TCR discovery efforts.

To overcome these challenges, T-knife has developed transgenic mice (HuTCR mice) carrying the human TCR gene loci and expressing multiple human HLAs. Immunizing HuTCR mice with human tumor antigens, for which mice are not tolerant, allows for the identification of both CD4+ and CD8+ T cells with TCRs that have optimized affinity / specificity profiles capable of mediating significant anti-tumor activity. The TCRs from HuTCR mice are of higher affinity for tumor self-antigens than TCRs isolated from human donors and are naturally optimized to maintain a high specificity profile, making HuTCR mice a powerful high-throughput platform for rapidly generating TCRs with best-in-class potential.

About T-knife TherapeuticsT-knife is a next-generation T-cell receptor (TCR) company developing a pipeline of therapeutics for solid tumor patients. The company leverages its proprietary humanized T-cell receptor (HuTCR) mouse platform to produce fully human TCRs, naturally selected in vivo for optimal affinity and specificity.

T-knife is developing a pipeline of potential first/best-in-class TCR therapeutics against targets with high unmet medical need, including cancer testis antigens, viral antigens and commonly shared neoantigens. T-knife was founded by leading T-cell and immunology experts using technology developed at the Max Delbruck Center for Molecular Medicine together with Charit University Hospital in Berlin. For additional information, please visit the companys website at http://www.t-knife.com.

Contact T-knife Therapeutics, Inc.Camille Landis Chief Business Officer / Chief Financial Officerinfo@t-knife.com

Sylvia WheelerWheelhouse Communicationsswheeler@wheelhouselsa.com

Dr. Ludger Wess / Ines-Regina Buthakampioninfo@akampion.com

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Study: Physical Exercise Improves Health of Brain and Other Organs through Epigenetic Changes | Medicine, Physiology – Sci-News.com

Posted: August 5, 2021 at 1:59 am

Some sections of our DNA are genes, which are instructions for building proteins, while other sections called enhancers regulate which genes are switched on or off, when, and in which tissue. New research from the University of Copenhagen and the Karolinska Institutet provides evidence of a functional link between epigenetic rewiring of enhancers to control their activity after exercise training and the modulation of disease risk in humans.

Exercise training rewires the enhancers in regions of our DNA that are known to be associated with the risk to develop disease. Image credit: Sasin Tipchai.

Regular physical activity decreases the risk of multiple common disorders such as cardiovascular disease, type 2 diabetes, cancer, and neurological conditions, along with the overall risk of mortality, said Professor Romain Barrs from the Novo Nordisk Foundation Center for Basic Metabolic Research at the University of Copenhagen and colleagues.

The beneficial effects of exercise training on human health are partially driven by adaptations of the skeletal muscle tissue.

Exercise-induced adaptations include coordinated changes in the expression of genes controlling substrate usage and metabolic efficiency in skeletal muscle.

In addition to the adaptations that occur within skeletal muscle cells, exercise exerts systemic effects on whole-body homeostasis by triggering the release of soluble factors from the muscle that signal to distal tissues, such as brain, liver, and adipose tissue.

The mechanisms by which training-induced adaptations of skeletal muscle orchestrate positive effects at the whole-body level are poorly understood.

We hypothesized that endurance exercise training remodels the activity of gene enhancers in skeletal muscle and that this remodeling contributes to the beneficial effects of exercise on human health.

For the study, the researchers recruited eight healthy Caucasian men (mean age 23 years) and put them through a six-week endurance exercise program.

They collected a biopsy of their thigh muscle before and after the exercise intervention and examined if changes in the epigenetic signature of their DNA occurred after training.

They discovered that after completing the endurance training program, the structure of many enhancers in the skeletal muscle of the young men had been altered.

By connecting the enhancers to genetic databases, the scientists found that many of the regulated enhancers have already been identified as hotspots of genetic variation between individuals.

Our findings provide a mechanism for the known beneficial effects of exercise, Professor Barrs said.

By connecting each enhancer with a gene, we further provide a list of direct targets that could mediate this effect.

The authors speculate that the beneficial effects of exercise on organs distant from muscle, like the brain, may largely be mediated by regulating the secretion of muscle factors.

In particular, they found that exercise remodels enhancer activity in skeletal muscle that are linked to cognitive abilities, which opens for the identification of exercise training-induced secreted muscle factors targeting the brain.

Our data provides evidence of a functional link between epigenetic rewiring of enhancers to control their activity after exercise training and the modulation of disease risk in humans, said Dr. Kristine Williams, also from the Novo Nordisk Foundation Center for Basic Metabolic Research at the University of Copenhagen.

The findings are published in the journal Molecular Metabolism.

_____

Kristine Williams et al. Epigenetic rewiring of skeletal muscle enhancers after exercise training supports a role in the whole-body function and human health. Molecular Metabolism, published online July 10, 2021; doi: 10.1016/j.molmet.2021.101290

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Excel Diagnostics and Nuclear Oncology Center Announces FDA Authorization of IND for 225Ac-PSMA I&T Targeted Alpha Therapy for Castration Resistant…

Posted: August 5, 2021 at 1:59 am

DetailsCategory: More NewsPublished on Wednesday, 04 August 2021 13:50Hits: 298

HOUSTON, TX, US AI August 04, 2021 I Excel Diagnostics and Nuclear Oncology Center (EDNOC), a premier Diagnostic Imaging and Radioligand Therapy center in Houston, Texas announces approval of its physicians sponsored Investigational New Drug (IND) application for providing Targeted Alpha Therapy (TAT) with 225Ac-PSMA I&T for metastatic Castration-Resistant Prostate Cancer (mCRPC). We are glad to be able to make this game-changing drug available to our patients suffering from mCRPC. Excel Diagnostics and Nuclear Oncology Center has been a pioneer in bringing new targeted Radioligand Therapies such as Lu-177 DOTATATE, and Lu-177 PSMA to serve our patients in the United States. The addition of 225Ac-PSMA I&T is in continuation of our mission to address unmet needs in the field of Nuclear Oncology said Dr. Ebrahim Delpassand, Chairman and Medical Director of EDNOC and Co-Principal Investigator of the trial. PSMA is an established prostate cancer target. Highly encouraging results have been reported by using Targeted Alpha Therapy (TAT) Radiopharmaceuticals in conditions such as neuroendocrine, prostate, or hematological malignancies. These breakthroughs have brought a significant amount of hope to our patients suffering from different types of advanced cancers. said Dr. Rodolfo Nuez, Director of Nuclear Medicine Department at EDNOC and Co-Principal Investigator of the trial. We are pleased to be able to facilitate the availability of 225Ac-PSMA I&T by manufacturing this drug at RadioMedix. We firmly believe that the menu of targeted Radioligand Therapies will only increase in the future. RadioMedix with its wide range of capabilities, from drug discovery to scale-up commercial manufacturing, is ready to meet this challenge said Dr. David Ranganathan, Director of CMC and Regulatory affairs at RadioMedix.

About Excel Diagnostics and Nuclear Oncology Center (EDNOC)

EDNOC is a premier outpatient facility offering a full spectrum of diagnostic imaging, nuclear medicine and Radioligand therapies. In addition to our comprehensive and state-of-the-art imaging services, we have assembled a staff of highly skilled technical and medical professionals to meet and exceed the demanding standards of the industry. EDNOC is fully capable of conducting sponsored clinical research trials in the field of diagnostic and therapeutic nuclear medicine. All our research staff is GCP Trained and CITI certified consisting of highly trained, board-certified investigators, study coordinators, patient recruiters, and support staff. At Excel, you will find areas designed to safely handle and administer radiopharmaceuticals, patient care areas, and physician interpretation resources. The Excel Clinical Research Department (ECRD) is a dedicated department to assist investigators in their clinical trials. Our team is fully trained regarding rules and regulations of conducting human research, FDA requirements, and IRB compliance. We offer our expertise in conducting clinical research to a variety of academic institutions and pharmaceutical companies. ECRD works closely with CROs & IRBs, to support sponsored clinical trials in the field of oncology radiopharmaceuticals. In April of 2020, Excel passed FDA inspection of one of its investigational drugs with no deficiencies or citations. For more information, please visit us at: http://www.exceldiagnostics.com

About RadioMedix

RadioMedix, Inc. is a clinical-stage biotechnology company, based in Houston, Texas, focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer. The company is developing radiopharmaceuticals for PET imaging and therapy (alpha and beta-labeled). RadioMedix has also established contract service facilities for academic and industrial partners including drug discovery and probe development core facility, a small animal molecular imaging facility for pre-clinical evaluation of radiopharmaceuticals, and cGMP and analytical suites for late-stage human clinical trials, and post-approval commercial manufacturing. To learn more, visit http://www.radiomedix.comand LinkedIn. For more information about this press release, please contact:This email address is being protected from spambots. You need JavaScript enabled to view it.">This email address is being protected from spambots. You need JavaScript enabled to view it.

SOURCE: RadioMedix

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Foundation Medicine Expands Indication for FoundationOneLiquid CDx to be Used as a Companion Diagnostic for TABRECTA (capmatinib) – Business Wire

Posted: July 21, 2021 at 2:20 am

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneLiquid CDx to be used as a companion diagnostic to aid in identifying patients with MET exon 14 skipping (METex14) in metastatic non-small cell lung cancer (NSCLC) for whom treatment with TABRECTA (capmatinib) may be appropriate. TABRECTA is the first therapy approved by the FDA for adult patients with metastatic NSCLC whose tumors have an alteration that leads to METex14. FoundationOne Liquid CDx analyzes the largest genomic region of any FDA-approved comprehensive liquid biopsy test and was approved by the FDA in August 2020 to report genomic alteration results for patients with any solid tumor.

NSCLC accounts for approximately 85% of lung cancer diagnoses,[1] 3 to 4% of which are associated with METex14.[2] Today's approval adds to the number of therapies for which both of Foundation Medicines FDA-approved comprehensive genomic tests are listed as companion diagnostics. FoundationOneCDx, Foundation Medicines tissue test, was approved as a companion diagnostic for TABRECTA in May 2020.

For lung cancer patients with METex14, having the option of a non-invasive liquid biopsy expands access to this first-of-its kind therapy and helps meet a critical patient need, said Brian Alexander, M.D., M.P.H., chief executive officer at Foundation Medicine. This approval, coupled with last years simultaneous therapy and companion diagnostic approval for TABRECTA and our tissue test, FoundationOne CDx, is an important advancement and demonstrates the value of having multiple highly-validated comprehensive genomic testing options for physicians to consider for the individual needs of each patient.

Using a simple blood sample, FoundationOne Liquid CDx analyzes over 300 cancer-related genes for genomic alterations. The test is now approved as a companion diagnostic for nine targeted therapies across four cancer types. TABRECTA is the second therapy for which both of Foundation Medicines FDA-approved tests, FoundationOne CDx and FoundationOne Liquid CDx, are listed as companion diagnostics.

Additionally, as a laboratory professional service which has not been reviewed or approved by the FDA, the FoundationOne Liquid CDx report delivers information about the genomic signatures microsatellite instability (MSI) and blood tumor mutational burden (bTMB), as well as single gene alterations, including NTRK fusions, to help inform the use of other therapies including immunotherapies. Also, as a laboratory professional service, the report provides relevant clinical trial information and includes interpretive content developed in accordance with professional guidelines in oncology for patients with any solid tumor.

Foundation Medicines strategic collaboration with Novartis now includes four companion diagnostics for the Novartis portfolio of targeted oncology therapeutics.

About FoundationOne Liquid CDx

FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and genomic alteration status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit http://www.F1LCDxLabel.com.

About Foundation Medicine

Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patients cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicines molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

Foundation Medicine and FoundationOne are registered trademarks of Foundation Medicine, Inc.

TABRECTA is a trademark of Novartis.

Source: Foundation Medicine

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Foundation Medicine Expands Indication for FoundationOneLiquid CDx to be Used as a Companion Diagnostic for TABRECTA (capmatinib) - Business Wire

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Making Room for Miracles And Modern Medicine as a Patient With Stage 4 Cancer – Curetoday.com

Posted: July 21, 2021 at 2:20 am

Its been said that late stage or terminal patients with cancer should have immediate, frank discussions with their oncologists about their prognosis. I understand the practical reasons for such advice, but Im not so sure I agree in other respects. Heres why. No one knows with absolute certainty how our bodies will react to treatment. The statistics dont lie, I understand, but they also allow for a slim margin some might chalk up to miracles and others to giant leaps in modern medicine.

My oncologist didnt tell me the stage of my ovarian cancer when she gave me my diagnosis. In fact, she said it was highly treatable. Notice she didnt term it highly curable. I didnt catch the difference at first. I discovered the metastatic stage 4 diagnosis on my patient portal page right before being admitted to the hospital for my port placement and first round of chemotherapy. It was shocking, scary and stressful. I dont recommend it.

However, in retrospect, I embrace my oncologists can-do attitude from the moment she gave me my diagnosis. She emphasized all the treatment options available to me, regardless of staging. She pointed out that new drugs and treatment protocols were constantly being developed. The longer I stayed alive, the more I had a chance at those new treatments. I decided my job was to actively participate in my treatment. Show up for appointments. Take medications as prescribed. Eat well. Exercise. Communicate about side effects. Pray. And live well.

The sad truth is I couldve done all those things and still succumbed to the disease. Ovarian cancer is the deadliest of the gynecological cancers. Depending on which statistics you believe, my five-year survival rate was somewhere between 19 and 30 percent. Im now in year six. I dont know why Im one of the women who has made it this far. Why am I not platinum resistant? Why did the frontline chemo and surgery result in a period of no evidence of disease (NED) for me and not for other women? Researchers point to molecular makeup of tumors, genetics and other health issues. Maybe those factors played a role. I dont know. So far, Ive survived two recurrences with the third NED period lasting almost two years now.

The point being I couldve had that get-your-affairs-in-order discussion with my doctor in January of 2016. I couldve implemented my bucket list, backed away from writing contracts, outlined my end-of-life wishes and prepared my children for my possible, impending demise. Instead, I signed a four-book contract and started a fulltime career as a fiction writer.

The only step I did take was to prepare a medical directive and a living will. It was the responsible thing to do. We should all do it. Anyone can be struck by tragedy at any moment. The fragility of life is no secret.

Im not trying to ignore grim reality. Nor do I embrace the always-be-positive Im going beat this thing mentality. Nor am I in the Gods got this camp. Yes, I pray and ask my church family to pray for me. I believe in the power of prayer. But I also ask myself why God would decide to answer my prayers and not those of the couple in the pew next to me whose daughter died of metastatic breast cancer a few years ago. Did they not pray hard enough? Part of Gods plan? I refuse to suggest a layperson like myself knows the answer to a question that stumps many learned theologians daily.

Im simply saying make room for miracles and modern medicine. Live every day with all your heart. Make the most of your time, however short or long. Thats good advice for all of us, cancer or not.

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Urgent action is necessary to stop the US Delta variant surge! – WSWS

Posted: July 21, 2021 at 2:20 am

The United States is in the midst of a major new upsurge of the COVID-19 pandemic that has already taken the lives of 624,000 people. Over the past month, daily cases have increased 250 percent, driving a rise in hospitalizations and a significant increase in the daily death rate.

The Delta (4th) wave in the United States is already showing it to be on a path to its the worst yet in major hotspots, noted Eric Topol, a professor of molecular medicine at the Scripps Research Institution.

The surge is concentrated in the poorest sections of the country, including Arkansas, Mississippi, Missouri, Florida and Nevada, where vaccination rates are lowest. In Missouri, the tenth-poorest state in the country which has one of the lowest vaccination rates, hospitals are at the highest occupancy at any point of the pandemic. We only get beds available when someone dies, which happens several times a day, Terrence Coulter, the critical-care medical director at CoxHealth, told the Atlantic.

The rise in cases is caused by the Delta variant of COVID-19, which not only spreads more rapidly, but reproduces much more aggressively inside infected people. A study published earlier this month noted that the viral load of people infected with the Delta variant was 1,000 times greater than those infected by the initial variant of the disease.

The surge in sections of the country with the lowest vaccination rates has been accompanied by a troubling growth in so-called breakthrough infections among vaccinated people. According to official figures from the US Centers for Disease Control and Prevention (CDC), 791 fully vaccinated people have died from COVID-19 in the US so far, and 5,000 have been hospitalized.

Three fully vaccinated athletes inside the Olympic village in Tokyo and one staff member tested positive over the weekend, raising the threat of new outbreaks at the worlds premier sporting event. In recent days, three fully vaccinated members of the Texas House delegation in Washington, D.C., tested positive after traveling maskless on a chartered airplane.

Moreover, less than half of the population in the US is fully vaccinated. While the media blames this fact on people who do not want to get the vaccine, the ruling class has been unwilling to organize the type of public education and mass distribution program that is required.

In recent days, it has become clear that the US government expects the upsurge that has already taken place in southern states to be merely the prelude to a new wave of the pandemic.

This is just going to spread through the population, Trumps former FDA director Scott Gottlieb told CNBC on Friday. He pointed to an internal CDC model showing an increasing epidemic, a wave of infection from this Delta variant moving through the population over the next two months.

The assumptions built into those models is no mitigation, no mandates for masks, no closures of businesses, Gottlieb added. I think thats likely to be the norm.

What Gottlieb is describing is the deliberate mass infection of the American population, allowing tens or hundreds of thousands more to die. The Trump-appointed FDA director was not describing some ideal world that would exist if the COVID-19 denier Trump was still in power, but the actual policies of the Biden administration.

On May 13, the CDC, under pressure from the Biden administration, announced that it was no longer recommending that vaccinated people wear masks, triggering the effective abandonment of all social distancing measures by businesses, states and municipalities throughout the country.

The World Socialist Web Site, in a position consistent with the World Health Organization and leading public health experts, opposed the CDCs decision, warning that it would lead to a new resurgence of the pandemic. Less than two months later, these warnings are being confirmed.

Facing the disastrous outcome of the White Houses policies, Bidens CDC Director, Dr. Rochelle Walensky, was asked last week, Is there any consideration, any scenario in which you might want to reverse yourself on reopening schools?

Walensky replied, I remain emphatic that our schools need to open in the fall. They need to open for full, in-person learning. When asked again, CDC is not recommending people who are fully vaccinated wear masks? Walensky responded, We are not.

The Biden administrations open opposition to masking and the end to all social distancing measures is virtually indistinguishable from the policies of former US President Donald Trump, whose disastrous handling of the COVID-19 pandemic was a major factor in Bidens victory.

220,000 Americans dead, Biden said in his opening remarks at the second presidential debate. Anyone is responsible for that many deaths should not remain as president of the United States of America. He added, I will take care of this. I will end this.

But since Inauguration Day, a further 196,000 people have died of COVID-19. That is, almost as many Americans have died under Biden as had died when Biden proclaimed anyone responsible for such mass death had forfeited his right to be president.

The president who pledged to follow the science is rejecting the demands of scientists, discouraging mask-wearing and peddling pseudo-science that children cannot be infected with COVID-19 and that schools are not centers for the transmission of the disease.

Tens of millions of people voted for Biden in the belief that he would take the measures necessary to stop the pandemic. But these promises were empty, because Biden, like Trump, represents the interests of the financial oligarchy that has massively enriched itself as hundreds of thousands have died.

It is urgently necessary to draw the lessons of the year and a half that has elapsed since the start of the pandemic. Under the banner of herd immunity, capitalist governments throughout the world made the calculated decision to sacrifice millions of lives because saving them would have impinged on the profit interests of the financial oligarchy.

With more than four million deaths, the mass of humanity is no closer to eradicating the pandemic than it was in March. Rather, the uncontained spread of the disease has led to the development of ever-more-dangerous variants.

Stopping the pandemic requires a radically different approach. This means the closure of schools and nonessential businesses, with full compensation for all those who lose any wage or small business income. This must be combined with the allocation of vast social resources to ensure that every case of COVID-19 is meticulously tracked and that every infected person is given a safe and comfortable place to quarantinewith full financial compensationuntil they are no longer infectious.

It is a fundamental fact that, despite the unanimous consensus of scientists on the measures necessary to contain COVID-19, there is only one political party in the United States calling for the stopping of nonessential production: the Socialist Equality Party, affiliated with the International Committee of the Fourth International that publishes the World Socialist Web Site. That is because the Socialist Equality Party does not accept the economic prerogatives of the capitalist class.

If COVID-19 is to be contained, it will only be through a mass mobilization of the working class to demand urgent measures to stop the pandemic, whatever the cost to the wealth of the financial oligarchy. The ill-gotten gains made by Americas billionaires while hundreds of thousands died must be seized and used to fund the measures necessary to stop the pandemic.

As the disease rips through workplaces, workers will form rank-and-file committees to demand the closure of non-essential production and the enforcement of critical safety guidelines. Teachers must and will resist the efforts to reopen schools for in-person learning under conditions in which the pandemic is still spreading.

The inability of the capitalist system to stop the spread of the COVID-19 pandemic has made clear the incompatibility of capitalism with the social needs of society. The struggle to save human lives in the pandemic is inseparable from the struggle for socialism.

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Sorry Folks But the Pandemic is Far From Over – Lynn Journal

Posted: July 21, 2021 at 2:20 am

We in Massachusetts are living in a bit of a pandemic bubble right now, both literally and figuratively. The high vaccination rate in our state, as well as in neighboring states throughout New England, has contributed to a dramatic drop in the number of COVID-19 infections, deaths, and hospitalizations in our part of the country. The successful reopening of our economy serves as a testament to the value of having a highly-vaccinated and highly-educated population.

Its as if our region of the U.S. is equivalent to an island nation such as New Zealand, where COVID-19 has not made a dent in economic or other activity since the beginning of the pandemic because its prime minister, Jacinda Ardern, sealed off its borders to foreigners from the very beginning of the pandemic. However, New England is not an island. Millions of our own citizens are traveling to other places and returning, and millions of non-residents are coming here to visit this summer.

The Delta variant of COVID-19 is now the dominant strain of the virus both in this country and throughout the world. The troubling aspects of Delta are that it is much more highly-transmissible than the original, it is more lethal, and the vaccines are slightly less-efficacious against it compared to the original strain of the virus for which the vaccines specifically were developed. In Australia (where vaccination rates are very low), the Delta variant has shown itself to be a whole new ballgame, so to speak, in terms of how contagious it is. The virus has been transmitted among people who simply came fleetingly into contact with each other and shared the same airspace in an indoor mall.

It is the most hyper-transmissible, contagious version of the virus weve seen to date, for sure its a superspreader strain if there ever was one, said Eric Topol, a professor of molecular medicine and an executive vice president at the Scripps Research Institution, in a recent interview in Scientific American. The Delta variant is being blamed for the huge increases in infections and deaths throughout the world, particularly in places where vaccination rates are in the low single digits. There also are many areas in the U.S., such as parts of Texas, Missouri, and Arkansas, where vaccination rates are low, that predictably now are seeing large increases in COVID-19 cases caused by Delta.

The Delta variant is concerning enough on its own, but the real problem is this: The more people who become infected with COVID-19, the more likely that the virus will mutate into additional variants, with the possibility that vaccination efficacy could begin to drop significantly if one of these strains develops an ability to evade the vaccines protective effects. It is nothing less than tragic and despicable, really that there are some in public life who are urging Americans NOT to get vaccinated.

That mindset was on display this past weekend at the Republican-dominated CPAC conference, where some clown on a panel who spoke out against the nations vaccination program was actually applauded by those in attendance. There is a strong and vocal minority in this country who strive to create chaos thats what makes them tick. Whether we as a nation can overcome the combination of venality and stupidity that was on display at CPAC this past weekend will determine whether we can beat the pandemic in the short term and whether our democracy and our way of life can survive in the long term

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