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Binx Health Gets CE Mark for Chlamydia, Gonorrhea Point-of-Care Test

NEW YORK (GenomeWeb) – Binx Health today announced that it has received CE marking for a chlamydia and gonorrhea (CT/NG) test that runs on its Binx io point-of-care platform and delivers laboratory-quality results in about 30 minutes.

"Rapid results equal rapid, appropriate treatment," Howard Heller, Binx Health's chief medical officer, said in a statement.

The firm's POC platform, which uses PCR amplification and electrochemical detection, enables users with no laboratory training to run the test and obtain a level of accuracy matching that of a central lab test, the firm said, making it ideal for use in a variety of approved medical and consumer settings.

The firm said that its platform enables patients and consumers to leave a retail pharmacy, primary care office, clinic, urgent care facility, and any other brick-and-mortar location with treatment in hand during a single visit. A mobile option enables physician-ordered, medical guideline-based testing online, the firm said.

The majority of CT/NG tests are currently sent to central laboratories, leaving up to a seven-day waiting period from first visit to treatment. During that time patients may spread infection, and up to 40 percent of patients receiving positive results don't return for treatment, said Binx Heath, citing a study published in the journal Sexually Transmitted Diseases.

The receipt of CE marking, which clears the test for marketing in European countries and others that accept the designation, enables test-and-treat care for two of the most prevalent sexually transmitted infections, Binx Health said.

The test has not been cleared for use in the US, but Binx Health recently completed a multi-center clinical study in preparation for applying to the US Food and Drug Administration for clearance under its 510(k) regulatory pathway.