The assay was cleared and CLIA-waived for use on Quidel's Sofia 2 instrument for the detection of RSV using nasopharyngeal swab and nasopharyngeal aspirate/wash specimens.
The distribution deal comes less than a month after the firm announced that the FDA cleared for marketing the revogene instrument along with the GenePOC GBS LB assay.
The firm established an "at-the-market" program to offer up to $21.2 million of its common stock from time to time. Proceeds will be used for business operations.
The firms will develop tests in the hematology oncology space where detecting large structural variations of the genome is crucial for accurate diagnoses.
The clinical laboratory giant signed a nonbinding letter of intent to buy Cape Cod Healthcare's outreach lab. Its hospital-based lab is not part of the deal, however.
Axon will distribute Biosurfit's POC instrument as part of the deal, which follows earlier agreements between the two firms covering Austria, Croatia, Slovakia, the Czech Republic, and Slovenia.
The test, designed to simultaneously detect diarrhea-causing enteric viruses using DNA extracted from a stool sample, includes norovirus GI, norovirus GII, and others.
Genoma, which is based in Italy, offers a wide range of specialty diagnostics services with an emphasis on noninvasive prenatal testing, as well as oncology tests.
The test is now covered by Premera Blue Cross, a regional health plan with more than 2 million members located primarily in Washington, Oregon, and Alaska.
OncoDNA said that it will use next-generation sequencing and immunohistochemistry assays to analyze patient to identify potential biomarkers and molecular alterations.
The collaboration will leverage DiaSorin's Liaion MDX PCR system, and Tecan's Fluent Laboratory Automation Solution to provide users a complete sample-to-result system.
The kit is designed to be used on the same platform as Grifols' other molecular typing platforms and can provide results within four hours of DNA extraction.
The fourth-generation assay is for the in vitro qualitative assessment of HIV-1 p24 antigen and antibodies to HIV-1 and HIV-2 in human serum and plasma.
