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The test is now approved as a CDx for advanced ovarian cancer patients considering Lynparza as a first-line maintenance treatment.
The firm’s test for detecting flu and differentiating between subtypes A and B is being launched in Europe, Asia, and South America.
The test covers 27 genes in which variants are known to contribute to the effectiveness or safety of more than 360 medications for 30 conditions.
The proposal establishes procedures and criteria for the de novo classification of medical devices that would clarify requirements for submission and review.
With the approval, MDxHealth can now offer its liquid biopsy molecular diagnostic assay in all 50 US states.
The company submitted the test to Japanese regulators for approval as a companion diagnostic for Daiichi Sankyo's acute myeloid leukemia drug quizartinib.
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.
The firm expects to begin distributing shipments of its FTL3 assay from LabPMM GK, the marketing authorization holder in Japan, in late 2018.
The firm will begin selling its ThyGeNext thyroid cancer diagnostic tool to physicians in New York and Pennsylvania in combination with ThyraMir.
Nature News reports that recent proposed changes to the US National Science Foundation have raised concerns about a shift away from the agency's focus on basic research.
Noel Rose, the "father of autoimmunity," has died at 92, the Washington Post reports.
According to CNN, Legionella was discovered in buildings leased by the Centers for Disease Control and Prevention as they reopened following coronavirus pandemic-related closures.
In PLOS this week: genetic analysis of malaria parasite populations in Southeast Asia, genomic surveillance of yellow fever virus in São Paulo, and more.