Recent diagnostic development paves the way for the introduction of Laccure® pessary

LACCURE GLOBAL OUTLOOK, 1 (2020)

There is no simple and easy test to diagnose bacterial vaginosis (BV) and there is no single bacterial strain attributable to BV infection. The most commonly used method for diagnosis are the Amsel criteria, where it is necessary to demonstrate three out of four of the following clinical criteria in order to accurately diagnose BV, including: typical homogeneous vaginal discharge, elevated pH level of the vaginal secretion, positive amine test (whiff test) and the presence of clue cells. The most notable disadvantages of Amsel’s criteria is the requirement of a clinical examination of the woman requiring a clinic visit to the gynaecologist.

Laccure has developed a non-prescription, antibiotic-free vaginal pessary for treatment and prevention of bacterial vaginosis. No matter what type of drugs or medical devices that are, or will be, available on the market, an accurate diagnosis must come first in order to choose a treatment that actually works effectively. It would be desirable to have access to a method which allows women to test themselves by using a simple self-test, and then obtain an accurate diagnosis through digital healthcare providers.

Recently a clinical study reported a very promising results in favor for such a test. The study, clinical trial registration # NCT04067557, was reported in the international Journal of Women’s Health and Gynecology, http://www.jscholaronline.org/articles/JWHG/Diagnosis-of-Bacterial.pdf. The study shows that molecular DNA tests, which determine both the quantity of bacteria and the relationship between them, provide a 94 percent safe diagnosis for bacterial vaginosis, which is significantly higher than the number of diagnoses made by clinical examination. The study was conducted with 300 pregnant women in a Swedish hospital.

“The results from the study are very encouraging. These types of new self-tests would facilitate the introduction of a product like Laccure® pessary on the market and will most certainly help women to get the best treatment in the near future,” comments Jeanette Folking, Ph.D., Project Leader at Laccure AB.

Laccure® pessary is a medical device product intended for treatment and prevention of bacterial vaginosis. This OTC product is not yet CE-marked or available on the market.