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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 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.
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.
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.
The Australian molecular diagnostics firm will use the funds to accelerate commercial expansion in North America and global markets.
The latest NYS Department of Health approval expands the company's CT/NG testing to samples from multiple relevant body sites.
The company received support from a Johns Hopkins University center focused on point-of-care device development for sexually transmitted infections.
The Washington Post reports that the CDC's SARS-CoV-2 test issues reflect earlier ones it had with Zika virus testing.
NPR writes that even with thousands of new COVID-19 papers, each should be evaluated based on its own quality.
Researchers traced a gene cluster linked to COVID-19 severity to Neanderthals, the New York Times reports.
In PNAS this week: soil bacteria-derived small molecules affect centrosomal protein, microfluidics approach for capturing circulating tumor cells, and more.