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 Hologic Aptima Combo 2 and the Cepheid Xpert CT/NG assays have now been cleared for use in throat and rectum samples.
The New York Times looks at companies using genomic tools to try to quickly identify the cause of patients' infections.
The White House has asked for $2.5 billion in funding to address the COVID-19 outbreak, according to the Associated Press.
A resignation at the Marine Biological Laboratory highlights that institutions are unsure of how to handle researchers previously found to have violated codes of conduct, Nature News says.
In PNAS this week: immune responses that affect heart transplant rejection risk, gene variants associated with thiopurine toxicity, and more.