The test is designed to detect cancer-driver gene variants associated with certain targeted solid tumor therapies, and is validated as a companion diagnostic.
The test is approved to gauge germline BRCA mutations in advanced breast cancer patients who may benefit from treatment with Pfizer's PARP inhibitor Talzenna.
The companion diagnostic for Pfizer's Xalkori identifies 14 ROS1 gene fusions by analyzing tumor messenger RNA from human tumor tissue or body fluids.
Archer will develop and pursue regulatory approval for a companion diagnostic that will help find patients who may benefit from one of Merck's drug candidates.
The new approval will allow the use of Qiagen's Therascreen EGFR RGQ PCR Kit as a companion diagnostic for Pfizer's Vizimpro in NSCLC patients.
The companies initially expect to incorporate a CDx for Incyte's pemigatinib into Foundation Medicine's existing FDA-approved assay, FoundationOne CDx.
The approval includes the use of either tumor tissue or plasma and follows previous approvals with Genentech's Tarceva (erlotinib) and AstraZeneca's Tagrisso (osimertinib).
Physicians can now use the Dako PD-L1 IHC 22C3 pharmDx assay to identify urothelial carcinoma patients who may benefit from the anti-PD1 immunotherapy.
The firm's next-generation sequencing diagnostic test analyzes tumor samples from multiple genomic mutations that are targeted by therapies for non-small cell lung cancer.
In addition, Qiagen has partnered with Japan's SRL for companion diagnostic development, and its CareHPV test was added to the WHO list of prequalified IVDs.
This drug is the first FDA-approved IDH1 inhibitor and will be used to treat adult patients with relapsed or refractory acute myeloid leukemia.
Analyst Puneet Souda said HTG has a growing funnel of biopharma projects that have the potential to convert to companion diagnostics with regulatory approval.
Under the new collaboration, Predicine will use its GeneRADAR technology to aid Kintor in the development and advancement of novel drugs.
The companies have launched a center that offers consulting and management specifically for genomically targeted or precision medicine trials.
The German drugmaker plans to advance the NSCLC treatment in parallel with tissue-based and liquid biopsy companion assays that can identify best responders.
The FDA will consider the companion diagnostic application alongside data for Pfizer's talazoparib in BRCA-mutated advanced breast cancer.
The company is planning to submit the drug and a companion diagnostic that can identify patients with FGFR alterations with the FDA in the second half of 2018.
Physicians can now use the Dako PD-L1 IHC 22C3 pharmDx assay to identify cervical cancer patients who may benefit from the anti-PD1 immunotherapy.
The companion diagnostic test identifies patients taking the Novartis drug Tasigna who are candidates for treatment-free remission monitoring.
The companies will jointly offer pathology and molecular testing services to PPD's pharmaceutical and biotechnology customers.
A Harvard University professor has been charged with making false claims regarding funds he received from China, the New York Times reports.
Discover magazine reports that animal dissections might dissuade students from science careers, but that a firm has developed synthetic frogs for dissections.
Nature News reports that a US panel is reviewing current guidelines for federally funded gain-of-function viral research.
In PNAS this week: de novo mutation patterns among the Amish, an alternative RNA-seq method, and more.