Palmetto GBA issued final local coverage determination for the tissue-based, 31-gene expression test, which determines a patient’s risk for metastatic disease.
The firm said that the assay uses vaginal or rectal swabs to identify Group B Streptococcus DNA in about an hour. It has filed for 510(k) clearance with the US FDA.
The test is designed to detect the presence or absence of the Zika virus in serum or plasma collected alongside urine from patients with suspected infection.
The deal covers Cancer Genetics' microarray-based Tissue of Origin test, which analyzes 2,000 individual tumor genes to help identify a tumor's origin.
The firm said it will use the net proceeds for R&D, including the continued development of its Acuitas AMR gene panels and Acuitas Lighthouse software.
The collaboration agreement includes support for development, regulatory submission, and commercialization of tests to guide use of Novartis' drug portfolio.
Roche Diagnostics' revenues were driven by its centralized and point-of-care solutions as well as its tissue diagnostics business, both rising in the high-single digits.
Molecular diagnostics revenues rose 5 percent driven in part by growth in infectious disease testing, a core area of diagnostic market focus for the firm.
The test is designed to detect cancer-driver gene variants associated with certain targeted solid tumor therapies, and is validated as a companion diagnostic.
The test is approved to gauge germline BRCA mutations in advanced breast cancer patients who may benefit from treatment with Pfizer's PARP inhibitor Talzenna.
The revenue growth was fueled by continued volume increases in Precipio's pathology services unit, which benefited from a recently expanded sales team.
The PCR assay is intended to help detect TB-causing bacteria and determine if it harbors mutations associated with isoniazid and rifampicin resistance.
The firm anticipates submitting its Acuitas AMR Gene Panel u5.47 for urinary tract infections and antibiotic resistance to US regulators by early next year.
The firm said the decline in Q4 revenues was due to an account loss as well as lower insurance reimbursement and shifts away from high-value genetic testing.
The partners are advancing a comprehensive report on how the detected PGx markers impact drug response and customized reports focusing on specific types of drugs.
The Lantern Project will screen for patients who may be suffering from Gaucher disease, Fabry disease, Pompe disease, MPS I, or ASMD, and offer confirmatory DNA testing.
DiaCarta scientists will partner with the University of Florida Health Cancer Center to analyze blood samples from up to 500 cancer patients undergoing radiotherapy.
