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.
This drug is the first FDA-approved IDH1 inhibitor and will be used to treat adult patients with relapsed or refractory acute myeloid leukemia.
The company is eyeing a launch for its IVD kits at the beginning of next year, as evidence grows for the integration of TMB analysis into the clinical care of cancer patients.
The companies will develop a version of Illumina's TruSight 170 sequencing panel for two of Loxo's targeted oncology drugs.
The ctDNA assay will be used to select patients for Phase 3 of Five Prime's registrational trial investigating bemarituzumab in gastric cancer patients.
China has been a key focus for Agena, which established a Shanghai subsidiary in 2015.
The company plans to grow its business based on the FDA approval and preliminary national coverage determination for its FoundationOne CDx test last year.
Researchers describe a way to share data while keeping it secure, Agence France Presse reports.
In Science this week: genetic mutations typically associated with esophageal cancer are common in older, healthy individuals, and more.
India's Council of Scientific and Industrial Research has a new director-general, according to ScienceInsider.
A new study links more than a hundred genes to autism spectrum disorder, Discover's D-brief blog reports.