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 SARS-CoV-2 Variants of Concerns Evolved to Modify Host Immune Response, Multiomics Study Shows People in the News at GA4GH, Mercy BioAnalytics, Deepcell, One Biosciences New Products Posted to GenomeWeb: Clinical Microbiomics, Integra Biosciences, DNAstack, Bruker Angolan Namib Desert Population Analysis Uncovers New Ancestry Group With Deep Divergence Cedars-Sinai Sets Up $25M Single Cell Precision Medicine Center The Scan Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants. Small Study of Gene Editing to Treat Sickle Cell Disease In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms. Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema. Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.