The partners are developing a point-of-care diagnostic kit that they anticipate will concurrently test for up to 20 types of infectious diseases in 20 minutes.
The company is developing a new gold standard comparator test after it encountered problems with typical culture methods it used in developing a new pneumonia assay.
The high-sensitivity test runs on the Quidel Triage Meter Pro instrument and joins a growing list of similar tests that have recently received regulatory approvals.
The draft guidance has been reissued with updates based on industry comments and is intended to lay out the steps necessary to get simultaneous 510(k) and CLIA waiver approval.
Factors that may have led to the explosion in testing include more consultations between patients and general practitioners, and a fear among GPs of being sued.
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based test for internal tandem duplications and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene.
The firm received approval for expanded use of its HIV Combo test, which detects HIV-1 and HIV-2 antibodies and the p24 antigen, on its Vitros ECi/ECiQ Immunodiagnostic System.
Australian Clinical Labs will take over the the clinical pathology and reporting responsibilities of Garvan Institute of Medical Research subsidiary Genome.One.
Roche will develop an immunohistochemistry-based companion diagnostic for Daiichi's investigational HER2-targeting antibody conjugate for breast cancer.
The companies will bring NIPD Genetics' Veracity and Veragene noninvasive prenatal tests to Medicover's markets, as well as developing new genetic tests.
