The agency has granted the drug and CDx priority review, which Myriad expects to conclude during its fiscal third-quarter ending March 31, 2018.
Theassay is designed for the rapid qualitative detection of platelet factor 4-heparin complex IgG antibodies associated with heparin-induced thrombocytopenia.
Participants shared data from head-to-head assay comparisons, reflected on the advancement of NGS and digital PCR methods, and discussed new standardization projects.
The FDA cited Euro Diagnostica for at least five violations stemming from an inspection of its facility in January, as well as inadequate responses to those violations.
The PCR-based test, run on Roche's Liat platform, was among several other assays that was cleared by the agency last month.
The test is intended for use by blood collection facilities and is not approved for the individual diagnosis of Zika infection.
Guardant is providing its Guardant 360 CDx test for a clinical trial of Merck's small molecule, c-Met kinase inhibitor called tepotinib.
Patients with PD-L1-expressing gastric or gastroesophageal junction tumors can now be identified for potential treatment with Keytruda using Agilent's assay.
The test, the fourth Zika serological assay available under EUA, qualitatively detects Zika virus IgM antibodies in human serum and plasma.
The assays are for diagnosing hepatitis B infection in individuals with acute or chronic hepatitis B, or who are recovering from hepatitis B infection.