trending Market Intelligence /marketintelligence/en/news-insights/trending/FIenAdeqt9gLiqyp-faV7Q2 content esgSubNav
Log in to other products

 /


Looking for more?

Contact Us
In This List

Hologic, Danaher tests gain FDA nod to detect chlamydia, gonorrhea

Blog

COVID-19 Impact & Recovery: Healthcare Outlook for H2 2021

Video

Climate Credit Analytics: Linking climate scenarios to financial impacts

Blog

Global M&A Infographic Q1 2021

Blog

Q1 2021 Global Capital Markets Activity: SPAC IPOs, Issuance in Consumer Discretionary Sector Surge


Hologic, Danaher tests gain FDA nod to detect chlamydia, gonorrhea

The U.S. Food and Drug Administration approved the use of Hologic Inc.'s Aptima Combo 2 Assay and Danaher Corp. unit Cepheid's Xpert CT/NG to detect two sexually transmitted diseases.

These devices are the first ones approved by the U.S. regulator to detect chlamydia, an infection caused by certain bacteria that can cause permanent damage to the reproductive system. The devices are also approved to detect gonorrhea, an infection that results in an inflammatory discharge from the urethra or vagina — through diagnostic testing of specimens taken from the throat or rectum.

Previously, the FDA had cleared these tests to diagnose the diseases using samples taken from urine, the vagina and the lower part of the uterus.

Earlier on May 23, the FDA also expanded the use of Roche Holding AG's cobas test for use in cobas 6800/8800 Systems to detect two additional sexually transmitted diseases — trichomonas vaginalis and mycoplasma genitalium.