The clearance covers tests made by the firm's joint venture for manufacturing, CoSara Diagnostics, in its facility in Ranoli, India.
OraSure will purchase Houston-based Diversigen, a microbiome and metagenomics consulting, sequencing, and data analysis service provider.
The company said that the decline in revenues reflected lower industry-wide reimbursement rates under PAMA.
The SuperExtract 32 with the SuperExtract Viral Mag NA Purification kit provides high-quality purification of hepatitis and HIV viral nucleic acid.
The tests run on the firm's sample-to-result automated molecular diagnostics instruments designed for use by high-volume labs.
The firm said its new molecular platform, which offers random-access testing, high throughput, and a broad menu has the potential to replace multiple instruments in molecular labs.
The kit, which was launched today, leverages real-time RT-PCR technology to detect and quantify hepatitis C virus-specific RNA with genotypes 1 to 6.
The assay is designed to quantitate HBV DNA in serum or plasma to assist in the treatment of chronic HBV-infected patients receiving antiviral therapy.
In PLOS this week: approach for teasing out archaic introgression in human genomes, immune transcription features in HCV infection, and more.
The test detects and quantifies hepatitis C virus RNA and can be performed in approximately one hour.
A Brazilian-led team of researchers reports it has generated a sugarcane genome assembly that encompasses more than 99 percent of its genome.
Certain plasma proteins could be used to gauge a person's age and whether they are aging well, according to HealthDay News.
GenomeWeb reports that Veritas Genetics is suspending its US operations.
In Science this week: approach to measure microRNA targeting efficiency, strategy to conduct high-throughput chemical screens at single-cell resolution, and more.