Industry News: Mologic Receives CE Mark Approval for BVPro Point-of-Care Diagnostic for Patients with Bacterial Vaginosis

20 Sep 2017


Mologic Ltd, which develops powerful, personalized diagnostics to improve the lives of patients, has announced it has received CE mark approval for BVPro®, a rapid point-of-care test for patients presenting with symptoms of vaginosis. The Company also announced the commercial launch of the test, and that it has signed a 3-year distribution agreement with Hitado GmbH, a leading diagnostic supplier specializing in point of care products, and subsidiary of Sysmex, to enable distribution of BVPro throughout Germany.

Bacterial vaginosis (BV) is an abnormal vaginal condition that is characterized by vaginal discharge and results from an overgrowth of atypical bacteria in the vagina. Although not critical in its own right, BV is associated with serious medical complications such as post-operative infections, a greater susceptibility of contracting sexually transmitted infections (STIs) such as genital herpes and HIV, and also a higher risk of preterm birth in pregnant women.

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BVPro is a simple, 15-minute, point-of-care diagnostic for professional use with patients presenting with symptoms of vaginosis. It detects sialidase enzyme activity from a vaginal swab sample which is a well-established clinical marker of bacterial vaginosis. The CE marked diagnostic has been designed in the familiar lateral flow format (typical of pregnancy tests) so that the visual result is easy to interpret and enables a rapid, alternative to current methods, such as wet mount microscopic analysis and test tube-based color-change assays, which often provide ambiguous results and are time consuming.

Mark Davis, co-founder and CEO at Mologic commented: “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). 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.

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