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The FDA cleared the point-of-care Binx io platform for the detection of chlamydia and gonorrhea in male urine specimens.
The GenFlex is a sample-to-result molecular diagnostic platform that includes sample collection, processing, amplification, and detection, the company said.
The firm said it is turbocharging the lateral flow format with sensitivity and cost suitable for over-the-counter STI testing.
The Ithaca, New York-based firm has submitted its molecular diagnostic instrument along with a test to detect chlamydia, gonorrhea, and trichomonas.
The company said that the decline in revenues reflected lower industry-wide reimbursement rates under PAMA.
Antelope's founder said that being spun off by MyCartis gives his company the focus it needs to launch tests for use in homes and doctors' clinics.
New resistance tests for Mycoplasma genitalium and gonorrhea could help stave off superbugs, but guidelines and economic factors may hinder adoption.
The clearance of the Binx io CT/NG test marks a milestone for the Johns Hopkins University group that funds early-stage development of rapid STI testing.
MyCartis said that the new company, Antelope Dx, is developing a home test to diagnose Chlamydia trachomatis and Neisseria gonorrhea.
The firm said its platform provides sample-to-answer results for two of the most frequently tested sexually transmitted infections, enabling rapid testing and treatment.