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If the proposal is finalized, the tests will go through a less burdensome process to obtain marketing clearances.
The firm saw strong increases in international HIV sales of its OraQuick HIV Self-Test product in the quarter.
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.
Nobel laureates and scientific societies urge NIH and the Department of Health and Human Services to revisit the recent decision to end funding for a coronavirus grant.
Bloomberg reports that BGI's SARS-CoV-2 testing sites in the Middle East have raised concerns among US officials.
A new Pew Research Center poll finds confidence in medical researchers has grown among US adults since the start of the coronavirus pandemic.
In Science this week: machine learning algorithm for faster Mendelian disorder diagnoses, gene linked to safe response to nitrogen-containing bisphosphonates, and more.