The clearance covers tests made by the firm's joint venture for manufacturing, CoSara Diagnostics, in its facility in Ranoli, India.
The firm is also targeting a new market for oral fluid-based tests for drugs of abuse, projecting future growth due to new federal regulations.
OraSure will purchase Houston-based Diversigen, a microbiome and metagenomics consulting, sequencing, and data analysis service provider.
It is the first time that the agency has authorized for marketing a next-generation sequencing test for HIV-1 resistance, the FDA noted.
Two new grants are helping the company develop its SHERLOCK and INSPECTR technologies as the basis for creating innovative diagnostics.
The company said that the decline in revenues reflected lower industry-wide reimbursement rates under PAMA.
Investigators at the Foundation for Research and Technology - Hellas, a Greek research institute, are coordinating the effort.
Peking University-led researchers edited stem cells an HIV patient was treated with in an attempt to cure disease, the Associated Press reports.
Analyzing blood transcriptome profiles for non-human primates, researchers narrowed in on a B cell gene expression signature that appears to coincide with protection from SIV, SHIV, or HIV.
NanoView will develop custom antibody-based assays on its ExoView platform to identify EVs containing biomarkers potentially linked to the neurological disorders.
Bloomberg Law writes that the Genetic Information Nondiscrimination Act may work better as a privacy, rather than anti-discrimination, law.
TechCrunch reports that Linda Avey has a new personal genomics startup that's focusing on India.
A new report finds that though the US has increased its activity in science and engineering, its global share of that activity has fallen in some areas, according to Inside Higher Ed.
In Nature this week: genomic analysis of rapeseed, universal target enrichment method for metagenomic sequencing, and more.