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If the proposal is finalized, the tests will go through a less burdensome process to obtain marketing clearances.
An increase in in the incidence of acute HCV infection in younger people, particularly those who inject drugs, contributed to the updated guidance.
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 firm said revenues fell because of delayed shipments of HIV self-tests and ongoing softness in the consumer genomics markets.
The tests run on the firm's sample-to-result automated molecular diagnostics instruments designed for use by high-volume labs.
The firm reported declines in revenues from its molecular collections systems, genomics products, and infectious disease tests, but still beat analyst estimates.
