ROS1 Biomarkers News and reporting on ROS1 biomarkers. Japanese Regulator Approves Foundation Medicine CDx for Roche's Rozlytrek in Lung Cancer The approval will allow clinicians to identify NSCLC patients with ROS1 fusion genes who could benefit from treatment with Rozlytrek. Global Survey Reveals Suboptimal Molecular Testing Access in Lung Cancer Despite Broad Guidelines Premium An IASLC survey showed that molecular testing is not performed in line with expert guidelines, which means only a minority of lung cancer patients are benefitting from precision oncology. Foundation Medicine to Seek FDA Approval for FoundationOne as CDx to Genentech's Rozlytrek The FDA has granted accelerated approval to Rozlytrek as a treatment for adult and adolescent patients with NTRK fusion-positive cancers. Inivata to Test Liquid Biopsy Against Tissue Sequencing in French Prospective Clinical Trial The study plans to recruit close to 300 patients with advanced non-small cell lung cancer, with half being treated based on liquid biopsy results. Japanese Regulator Approves Foundation Medicine CDx Assay for Roche's Rozlytrek Regulators in the country granted additional approval of the test as a companion diagnostic for Rozlytrek, marketed in Japan by Roche's Chugai Pharmaceutical. Jun 4, 2019 At ASCO, Real-World Data Shows Potential to Improve Precision Oncology Premium May 16, 2019 Roche Drug Shows Benefit in Pediatric Patients With Rare, Molecularly Defined Tumors Premium Apr 10, 2019 Foundation Medicine, Flatiron Health Publish Clinical Validity of Clinico-Genomics Database Dec 19, 2018 FDA CDx Class Labeling Draft Guidance May Ease Patient Access, Spur Competition Among Test Makers Premium Nov 1, 2018 Almac Developing Next-Generation Sequencing Assay for TP Therapeutics' Anti-Tumor Therapy Premium Jan 24, 2018 Lung Cancer Molecular Testing Guidelines Updated by CAP, AMP, IASLC Sep 12, 2017 Ignyta to Seek Entrectinib Approval in ROS1-Positive Lung Cancer, Tissue-Agnostic Indication Premium Sep 7, 2017 Patient Advocacy Strategies Evolve as Genomic Advances Change Understanding of Cancer Aug 15, 2017 ASCO Updates NSCLC Guidelines With New Directives for Genomic Testing Jun 22, 2017 Thermo Fisher Next-Gen Sequencing Panel Wins FDA Approval as Companion Test Jun 6, 2016 Lung Cancer Drugs Yield Benefit in Rare Molecular Patient Subsets, ASCO Studies Show Premium Dec 16, 2015 FDA Acts Quickly on Personalized NSCLC Drugs; Reviewing Xalkori in ROS1-Positive Cases Premium Sep 22, 2015 Early Study Results Find High Proportion of Young Lung Cancer Patients With Targetable Mutations Premium Aug 31, 2015 Updated ASCO Recommendations for Advanced NSCLC Include EGFR-, ALK-, ROS1-Guided Precision Options Premium Feb 17, 2015 With Latest Orphan Status for Entrectinib in CRC, Ignyta Continues to Pursue Precision Rx Approach Premium Jun 6, 2012 Early Data Convinces Some Oncologists to Treat ROS1-Positive NSCLC Patients with Xalkori Premium Breaking News FDA Revises SARS-CoV-2 Test Emergency Use Authorization Requirements to Account for Variants Geisinger Wins $5M NIH Grant to Develop Point-of-Care Genetic Diagnostic Tool Second Genome, Virginia Commonwealth University Partner on NASH Biomarker Discovery LGC Receives CE Mark for AccuPlex SARS-CoV-2, Flu A/B, RSV Reference Material Kit Esophageal Cancer Testing Firm Lucid Diagnostics Files For IPO Twist Bioscience, DeepCDR Collaborate on Antibody Library Design The Scan Booster for At-Risk The New York Times reports that the US Food and Drug Administration has authorized a third dose of the Pfizer-BioNTech SARS-CoV-2 vaccine for people over 65 or at increased risk. Preprints OK to Mention Again Nature News reports the Australian Research Council has changed its new policy and now allows preprints to be cited in grant applications. Hundreds of Millions More to Share The US plans to purchase and donate 500 million additional SARS-CoV-2 vaccine doses, according to the Washington Post. Nature Papers Examine Molecular Program Differences Influencing Neural Cells, Population History of Polynesia In Nature this week: changes in molecular program during embryonic development leads to different neural cell types, and more.