Med Device Monday: Bacterial Vaginosis Detection

Bacterial Vaginosis is a relatively common condition in which an overabundance of certain bacteria upsets the balance in the vaginal environment, which can lead to unpleasant symptoms and discomfort. It's also known more generally as vaginitis or vaginosis: common symptoms can indicate a variety of conditions and causes (Bacterial Vaginosis (BV), Trichomoniasis (TV), and Vulvovaginal Candidiasis (VVC)–more commonly known as a yeast infection), making it difficult to know exactly what a patient is presenting with and thus how to treat it. While BV can be inconvenient and unpleasant, it can also lead to complications if left untreated: low birth weight, premature birth, miscarriage, and increased risk of contracting an sexually transmitted disease (STDs) are all potential complications.

It's not known exactly how BV's bacterial imbalance occurs. Although it affects sexually active women almost exclusively, it is not a sexually transmitted disease or infection (STD, STI) though it it is commonly perceived as such. (The CDC offers a "Fact Sheet" on BV with basic info, symptoms, etc., and interestingly, although the CDC website explicitly states that BV is not an STD, it is listed in the STD section of their site.)

Screenshot from molecular

Screenshot from molecular

BV, TV, and VVC are commonly treated with a single dose of oral antibiotics and/or vaginally inserted antibiotic creams. Because of the overlapping symptoms of these conditions, pinpointing the most effective antibiotics has, until recently, been difficult. Prescribing the wrong antibiotic to correct the balance can lead to prolonged symptoms and infection. 

Enter the BD MAX™.

Granted just last week via the de novo pathway, you can read FDA's approval letter here. This simple in-office vaginal panel pinpoints the exact bacterial levels present in the vagina, and thus allows doctors to prescribe the precise medicine needed to treat the infection.

This press release from BD sums up the difficulties with vaginal infections, their diagnosis, and the need for this device quite nicely. I recommend reading the whole thing but this bit in particular sums up the importance of this device:

""Vaginitis is highly prevalent, with large gaps in clinical management that improved diagnostics could help address," said Dr. Mark Martens, MD, FACOG, Shair, Dept. of Obstetrics and Gynecology Jersey Shore University Medical Center, part of the Hackensack Meridian Health. "Traditional methods used to detect vaginitis can be challenging due to the presence of many interfering substances in specimens, the large number of mixed infections, and the subjectivity of these methods. A multiplex micro biome-based real-time PCR assay has the potential to help clinicians improve patient management and help laboratories increase workflow efficiency."  

Vaginal infections result in more than 10 million office visits each year in the US, with up to 75 percent of women experiencing at least one case of Vaginitis (VVC, TV) or Vaginosis (BV) in their lifetime. As many as half the women who suffer from vaginal infections incorrectly assume it is a simple case of a yeast infection and attempt to self-treat with over-the-counter options before consulting a clinician. Additionally, inaccurate and inconsistent diagnosis of these conditions can leave up to 30 percent of women seeking treatment with the wrong diagnosis. This can lead to continued symptoms, repeat visits, inappropriate or missed treatment and unnecessary associated health care system costs. In addition to irritating symptoms that disrupt quality of life, these infections can have serious risks, including pre-term or low birth-weight babies, late term miscarriage, and increased risk of STI transmission or acquisition such as HIV and Pelvic Inflammatory Disease (PID)."

A personalized diagnosis that will allow for precise treatment and potentially avoid further complications, expense, and repeat treatments is certainly a victory for women and reproductive health!


Interested in further reading? I work exclusively with medical devices, but you can read FDA's guidance doc for developing antimicrobial BV drugs here.