The LeukoStrat CDx FLT3 Mutation Assay can now be used in Japan as the CDx for quizartinib for the treatment of FLT3-ITD positive relapsed or refractory AML.
The drug is for first-line maintenance therapy after BRCA-mutated advanced ovarian cancer patients respond to platinum chemo and the test will identify those with BRCA mutations.
The firm said that with the approval, the firm's liquid biopsy-based ExoDx Prostate IntelliScore (EPI) test is now available in every state.
The draft guidance also provides recommendations about communicating the results of biotin interference testing to users of diagnostic tests.
Applied BioCode said that it now has access to higher volume laboratories that use the Roche MagNa Pure 96 System for sample extraction.
The diagnostic can now be used to identify patients with head and neck squamous cell carcinoma who may benefit from first-line treatment with Keytruda.
Siemens Healthineers received clearance for its Dimension Exl High-Sensitivity Troponin I Assay used to diagnose acute myocardial infarction.
Akonni has received clearance for a molecular diagnostic instrument and a saliva-based pharmacogenomics test for warfarin metabolism.
The assay is for detecting varicella-zoster virus in cerebrospinal fluid and can be used with the firm's Liaison MDx instrument.
The digital pathology system can be used for primary diagnosis as a result of the 510(k) clearance, which followed a multicenter study conducted at five clinical sites.
The immunoassays are are indicated for the quantitative determination of IgM RF antibodies and the semi-quantitative determination of IgA RF antibodies.
The Aptima BV test detects bacterial vaginosis and the Aptima CV/TV detects and differentiates candida infections from trichomonas.
The self-administered test is designed to detect human chorionic gonadotropin levels in women as early as six days before a first missed period.
The designation will enable the South Korea-based squencing services provider to perform NGS analysis of clinical trial samples.
The test will be used to identify which advanced or metastatic breast cancer patients with PIK3CA mutations are likely to respond to Novartis' alpelisib.
The CD Diagnostics lateral flow test detects human alpha defensins proteins in the synovial fluid of patients with a total joint replacement in about 10 minutes.
The agency said that it is the first diagnostic test for detecting Zika virus immunoglobulin (IgM) antibodies that it has allowed to be marketed in the US.
Clever Culture Systems said its platform can process more than 200 culture plates at a time and automatically screen, interpret, and sort them.
The Cobas TV/MG test detects Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) DNA in symptomatic and asymptomatic patients.
The Hologic Aptima Combo 2 and the Cepheid Xpert CT/NG assays have now been cleared for use in throat and rectum samples.