Mologic grabs CE mark for POC vaginosis test

CE mark showing construction lines
Many women with bacterial vaginosis do not have symptoms, but the infection may lead to more serious conditions.

Mologic received a CE mark for its point-of-care test that rapidly diagnoses bacterial vaginosis, an infection caused by an imbalance of bacteria. 

Bacterial vaginosis (BV) is the most common vaginal infection in women aged 15 to 44. It is typically diagnosed in an examination, but a physician may also take samples for lab tests, the CDC says. While not necessarily serious on its own—the infection may resolve without treatment—BV can increase the chance of contracting STIs, such as HIV. It can also cause preterm birth in pregnant women. 

Mologic's BVPro test detects activity of the sialidase enzyme from a vaginal swab sample. It uses a lateral flow immunoassay system and returns results within 15 minutes, the company said. 

"BVPro is another in Mologic’s pipeline of diagnostic tests to receive CE mark approval. We are very pleased to be making such progress in bringing point of care tests to patients and by doing so, enabling the earlier treatment of a range of diseases, including sepsis, urinary tract infections and chronic obstructive pulmonary disease (COPD)," said Mologic CEO Mark Davis in a statement. 

The company will roll out the product starting with a three-year distribution agreement with Hitado, which will market the product in Germany. 

"Appointing Hitado to distribute our products in Germany represents a significant milestone for our company; we look forward to working with them as our first formal distributor and also others as we bring them on board in different geographies," Davis said. 

Earlier this year, Mologic scored a CE mark for its POC test that detects infection in patients undergoing peritoneal dialysis. Unlike traditional hemodialysis, which uses an external filter to clean the blood, peritoneal dialysis uses the peritoneum—the membrane that lines the inside of the abdomen—as a natural filter. As a result, patients may receive this treatment while they go about their daily activities. Mologic's Periplex test returns results within 10 minutes, while other tests may take up to 24 hours. Once alerted, a patient may then seek care.