PHILADELPHIA, March 20, 2018 /PRNewswire/ -- Coriell Life Sciences, Inc. (CLS), an innovative provider of clinical genetic reporting solutions, today announced the launch of their next-generation solution for the quantitative diagnosis and reporting of bacterial vaginosis (BV). The test can simultaneously aid in the differential diagnosis of other vaginal infections that clinically present with the same signs and symptoms as BV.
There are more than 10 million office visits annually due to vaginal infections.1 Bacterial vaginosis is the most common vaginal infection among women 15 to 44 years of age. While asymptomatic in as many as 84% of cases, BV can lead to an array of symptoms, including an unpleasant vaginal odor, discharge, and itching. BV also increases the risk of severe complications in pregnant and postpartum women. It puts women at higher risk of acquiring HIV and other sexually transmitted infections (STIs). Finally, among those already infected with HIV, BV increases viral shedding.2
Traditionally, diagnosis of BV requires laboratory examination of vaginal smears by microscopy. Based on a manual assessment of the bacterial organisms observed, an associated Nugent score is assigned. Alternatively, clinical signs can be assessed using the Amsel criteria. "Unfortunately, both methods rely on subjective criteria and are prone to human error," said Scott Megill, President and CEO of Coriell Life Sciences. "Neither method can definitively distinguish between BV and other, related infections that require different treatment and management protocols."
The response from CLS and Quantigen was to develop a quantitative assay and reporting algorithm that runs on Thermo Fisher Scientific's real-time PCR-based OpenArray™ technology. The platform provides an affordable and comprehensive sample analysis with rapid turnaround times. This allows CLS to report, with high specificity, which microorganisms are present and at what quantities.
"We didn't stop there," said Jeffrey Shaman, PhD, Director of Business Development at CLS. "This new molecular Women's Health Report provides complete decision support, with diagnosis and treatment options for BV as well as candidiasis, trichomoniasis, and other sexually transmitted infections (STIs). We also take into account pregnancy status and prior infection history, which influence the treatment protocols."
Building upon a previous clinical trial, the Indiana-based Quantigen Genomics, which designs and executes customized research projects, tested hundreds of symptomatic and non-symptomatic patients and compared the results of the CLS algorithm against those of Nugent testing, Amsel scoring and other, less comprehensive molecular tests. "Our trials enabled Coriell Life Sciences to refine and validate its algorithm to offer reporting with greater sensitivity and specificity than current testing methods," said Doug Rains, CSO of Quantigen.
"We now have a truly quantitative way to measure the presence of bacterial vaginosis with a high degree of accuracy," said Shaman. "Because we're not waiting for a culture, results can be had much faster, with diagnosis reporting measured in hours rather than days."
Treating physicians can now order a comprehensive or targeted vaginal microbiota panel covering up to 34 microorganisms from a single vaginal swab, with reports provided within 24 hours of sample receipt. For labs running Thermo Fisher equipment, the new quantitative reporting platform from CLS provides faster, more accurate results with immediately actionable guidance for informed decision-making.
About Quantigen Genomic Services
Quantigen, founded in 2008, is both a diagnostic testing laboratory and a full-service contract research organization (CRO). In addition to women's health testing, Quantigen offers an array of diagnostic options in the fields of infectious disease and genetic testing. As a CRO, the laboratory works closely with its various biotechnology and pharmaceutical partners to carry out both basic and translational research, from companion assay development and validation to early-stage clinical trials. For further information, please visit www.quantigen.com
About Coriell Life Sciences
Coriell Life Sciences is the commercial arm of the world-renowned, non-profit Coriell Institute for Medical Research. The organization's focus is to bridge the gap between genetic science and clinical application. It provides a testing and reporting infrastructure for women's health and other healthcare scenarios that require the use of genetics to provide more precise, more appropriate care for patients. Coriell Life Sciences has also created the most comprehensive medication safety solution in the market with its core products: GeneDose, GeneDose LIVE, and SafeTRx. For more information, visit www.coriell.com/wh
1. Christina A. Muzny, Jane R. Schwebke, in Women and Health (Second Edition), 2013.
2. Koumans EH, Sternberg M, Bruce C, McQuillan G, Kendrick J, Sutton M, Markowitz LE. The prevalence of bacterial vaginosis in the United States, 2001-2004; associations with symptoms, sexual behaviors, and reproductive health. Sex Transm Dis. 2007 Nov;34(11):864-9.
SOURCE Coriell Life Sciences