Clovis Oncology FDA Approves Foundation Medicine Liquid Biopsy Test as CDx for Three Targeted Therapies FoundationOne Liquid CDx can now be used as a companion diagnostic for therapies to treat advanced ovarian, breast, and non-small cell lung cancer. Treatment With Less Toxic Rubraca in Molecularly-Defined Pancreatic Cancer Subset Proposed at AACR Premium Maintenance treatment with Clovis' rucaparib may be a more tolerable maintenance therapy than chemo in platinum-responsive patients with mutations in BRCA1/2 or PALB2. Clovis, Myriad Genetics Working to Meet Post-Market Study Commitment for PARP Inhibitor Myriad said it will submit a supplementary premarket approval application for its BRACAnalysis CDx, which the FDA originally approved in 2014. Clovis, Strata Partner to Identify Prostate Cancer Best Responders to PARP Inhibitor Strata will refer castration-resistant prostate cancer patients with BRCA and ATM mutations for potential enrollment in Clovis' Rubraca studies. Foundation Medicine's Regulatory Win for NGS CDx Sets Precedent; Adoption Challenge Remains Premium FDA clearance of the first NGS companion diagnostic paves the way for other comprehensive genomic profiling tests, but Foundation will have to educate docs on the benefits of its test. Dec 19, 2016 Foundation BRCA CDx is First NGS Companion Test to Get FDA Nod Feb 18, 2015 Clovis Evaluating Sysmex Inostics Blood Assay to ID EGFR Mutations in ctDNA of NSCLC Patients Premium Nov 24, 2014 In Ongoing Phase II Trial, Clovis Still Refining 'BRCAness' Signature for PARP Inhibitor Rucaparib Premium Aug 13, 2014 Clovis Reports Increased Q2 Net Loss, Spending with Advancing Personalized Cancer Drug Trials Premium Jun 25, 2014 Clovis Launches TIGER2 Trial for CO-1686 in Previously Treated T790M-Positive NSCLC Patients Premium Jun 18, 2014 MDx/CDx Focus: FDA Clears Sequenom IMPACT Dx; Agency Accepts AbbVie HCV Regimen NDA; and More Premium Jun 4, 2014 At ASCO, Next-Gen EGFR Inhibitors Show Early Promise in Lung Cancer Patients with T790M Mutations Premium Nov 20, 2013 Clovis Oncology Outlines Clinical Program for PARP Inhibitor Rucaparib Using Foundation's NGS Test Premium Sep 27, 2013 Copenhagen Team's Proteome-Wide Protein PARylation Study Could Aid PARP Inhibitor Development Premium Nov 14, 2012 Clovis Pulls Plug on Personalized Cancer Drug after Trial Shows No Benefit for Drug or Marker Premium Oct 10, 2012 Clovis on Track to Unveil Data on New Personalized Pancreatic Cancer Treatment Option by Year End Premium Aug 6, 2012 Foundation Medicine, Clovis to Co-develop IVD for Drug Candidate Jan 30, 2012 OHSU Team IDs Protein Signature Linked to 'BRCAness' Profile for Ovarian Cancer Recurrence Premium Jan 18, 2012 Ventana's Growing Companion Dx Focus Mirrors Parent Roche's Investment in Personalized Rx Premium Jul 27, 2011 Roche Gets Positive CHMP Review for Tarceva as First-line Treatment in EGFR-mutated NSCLC Premium Jun 2, 2011 Dx Focus Jun 2, 2011: Clinical and Regulatory PCR and Nucleic Acid Testing News Premium Jun 2, 2011 Roche, Clovis Co-developing Companion Diagnostic for EGFR Mutations May 26, 2010 Clovis, Avila to Co-develop Targeted NSCLC Drug with Companion Test in Deal Worth up to $209M Premium Jul 24, 2009 MoneyTree: Nation's Biggest Bioclusters Record Declines in VC Spending in Q2 Premium Breaking News Long COVID Clues Found in Acute SARS-CoV-2 Infection Blood Samples People in the News at Roche, Mammoth Biosciences, NeoGenomics, Molecular Assemblies, More New Products Posted to GenomeWeb: Thermo Fisher, Element Biosciences, Dante Genomics, More Tesis Biosciences to Develop miRNA Biomarkers for mTBI Diagnosis In Brief This Week: Danaher, Lucira Health, Novacyt, Molecular Devices The Scan Cell Atlas of Human Lung Development Gives View of Developing Airway Researchers have generated a cell atlas of human lung development, which they report in Cell. Study Finds Costs of Genome Sequencing May Limit Utility in Routine Care Researchers report in the European Journal of Human Genetics that genome sequencing for rare disease diagnoses currently has similar benefits as less expensive exome analysis. Study Suggests Nursing Mother's Diet Can Impact Offspring's Gut Microbiome A new Cell Host and Microbe paper finds that mice whose mothers were fed a low-fiber diet during nursing experience lasting microbiota dysbiosis and increased obesity. Study Links Genetic Risk for ADHD With Alzheimer's Disease A higher polygenic risk score for attention-deficit/hyperactivity disorder is also linked to cognitive decline and Alzheimer's disease, a new study in Molecular Psychiatry finds.