The tests from Asuragen and MolecularMD are designed for use in chronic myeloid leukemia patients, including those receiving tyrosine kinase inhibitor therapy.
Agena has an ongoing partnership with Guangzhou-based DaRui to develop MassArray-based diagnostics for cancer and inherited diseases for the Chinese market.
An Oregon Health Authority committee issued a draft guidance to not cover NGS testing for solid tumors, which advocacy groups say will limit access to Medicaid beneficiaries.
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).
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.
The Fusion module is an in-lab upgrade to Hologic's Panther instrument, which enables labs to extend the testing capabilities of their existing Panther.
The firm's LeukoStrat CDx FLT3 Mutation Assay detects internal tandem duplications and tyrosine kinase domain mutations in patients with acute myeloid leukemia.
