USA — Cepheid has launched Xpert Xpress Multiplex Vaginal Panel (MVP), a multiplexed PCR test that detects DNA from organisms associated with vaginitis from a single sample, aiding in more accurate diagnosis and antibiotic treatment regimens.
The assay is designed to detect the three most common causes of vaginitis (i.e., bacterial vaginosis markers, Candida species, and Trichomonas vaginalis) with results within 60 minutes, significantly narrowing the test-to-treatment gap and better supporting patient outcomes.
Bacterial vaginosis (BV) and other vaginal health conditions affect 30% of women worldwide can negatively impact a woman’s quality of life, and become an economic burden.
If left untreated, vaginitis can lead to serious complications and risks such as miscarriage, premature births, and HIV-AIDS.
Other diseases, such as gonorrhea, chlamydia, and papillomavirus, have been linked to potential complications.
The fact that the majority of patients are asymptomatic makes detecting vaginitis difficult. This makes it difficult to prescribe appropriate medications.
Misdiagnosis of the specific underlying causes of vaginitis and vaginosis often leads to inappropriate and ineffective treatments and, in some cases, an increased risk of developing serious complications and antibiotic-resistant organisms.
With the addition of the MVP, physicians can quickly and accurately identify their patient’s infection and prescribe the correct treatment regimen, with the goal of avoiding multiple office visits associated with therapeutic failure.
The primary treatment course for BV is antibiotics, but the rate of BV recurrence after therapy is high, often greater than 60 percent according to Cepheid.
Metronidazole has been the standard treatment for BV for more than 25 years, with 4-week cure rates as high as 85%.
In a separate development, the Bill & Melinda Gates Foundation has granted Daré Bioscience US$584,986 to support its efforts related to the development of a vaginal thermosetting gel formulation for the delivery of live biotherapeutics that can be reconstituted at the point of care.
Scientific evidence suggests that there may be potential benefits to administering live bacterial cultures to rebalance the vaginal microbiota disrupted by the infection.
The US FDA approved Daré Bioscience’s clindamycin phosphate vaginal gel, 2% for the treatment of bacterial vaginosis in females 12 years of age and older in December 2021.
Daré’s portfolio also includes potential first-in-category candidates in clinical development such as Ovaprene, a novel, hormone-free monthly intravaginal contraceptive whose US commercial rights are under a license agreement with Bayer.
Others candidates in the pipeline include Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone therapy following menopause.
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