FDA-approved PCR test aids for faster identification of three different conditions within one hour
Sunnyvale, California., November 15, 2022 /PRNewswire/ — Cepheid announced today that it has launched Xpert Xpress MVP, a multiplex PCR test that detects DNA from organisms associated with three different diseases – bacterial vaginosis (BV), vulvovaginal candidiasis and trichomoniasis – from a single sample, contributing to more accurate diagnosis and antibiotic treatment regimens.
Each year, approximately 10 million women’s doctor visits in the United States are related to vaginitis symptoms1. Diagnosis of vaginitis is often made through clinical examination2 where the doctor prescribes a treatment regimen that may not target the patient’s specific type of infection. Consecutive treatment errors prolong patient suffering and increase the potential for antimicrobial resistance. Because the pathogens come from three different classes of pathogens, but have similar symptoms3precise diagnosis made possible by multiplex PCR testing can enable more targeted and timely treatments.
BV is the most common cause of vaginitis/vaginosis syndrome, but vaginitis can also be caused by trichomonads and yeasts such as Candida. The use of antibiotics is a major factor in this Candida overgrowth4, so identifying the underlying infection is critical to reducing antibiotic overuse. The recurrence rate of BV after therapy is high, often greater than 60 percent5and compared to a molecular test, empirical approaches can miss 45.3% of positive cases and misidentify 12.3% of negative cases as positive6.
“Misdiagnosis of the specific underlying causes of vaginitis and vaginosis often leads to inappropriate and ineffective treatments and, in some cases, to an increased risk of developing serious complications and antibiotic-resistant organisms,” he said David Persing, MD, Ph.D., EVP and Chief Scientific Officer. “With the addition of the MVP to our growing women’s health portfolio, physicians can quickly and accurately identify their patient’s infection and prescribe the right treatment regimen, with the goal of avoiding multiple visits related to treatment failure.”
expert Xpress MVP helps clinicians detect these infections, including co-occurrence from a single sample with a detection time within 60 minutes, significantly reducing the test-to-treat gap and better supporting treatment outcomes.
Learn more about Cepheid’s Xpert Xpress MVP test, please visit Cepheid website.
Based in Sunnyvale, California, Cepheid is a leading molecular diagnostics company that is an operating company within the Diagnostics platform of Danaher Corporation (NYSE: DHR). Cepheid is dedicated to improving healthcare through the development, manufacture and marketing of precise yet easy-to-use molecular systems and assays. By automating highly complex and time-consuming manual processes, the company’s solutions offer institutions of all sizes a better way to perform sophisticated genetic testing for organisms and genetic diseases. Through its strong molecular biology capabilities, the company focuses on the applications where accurate, rapid and actionable test results are most needed, such as: B. the treatment of infectious diseases and cancer. Visit http://www.cepheid.com for more information.
1 Cammarata, CLBS; Stonebraker, E.BS; Eckert, K.MS; Van der Pol, B. PhD, MPH; Taylor, SN MD. (2021) Performance of a vaginal panel assay compared to clinical diagnosis of vaginitis. Obstetrics & Gynaecology: December 2021 – Volume 138 – Issue 6 – pp. 853-859. https://journals.lww.com/greenjournal/Fulltext/2021/12000/Performance_of_a_Vaginal_Panel_Assay_Compared_With.6.aspx
2 Mayo Clinic. Vaginitis: Diagnosis. https://www.mayoclinic.org/diseases-conditions/vaginitis/symptoms-causes/syc-20354707
3 Mayo Clinic. Vaginitis: overview. https://www.mayoclinic.org/diseases-conditions/vaginitis/symptoms-causes/syc-20354707
4 Centers for Disease Control and Prevention. (2010). Bacterial vaginosis – CDC fact sheet. https://www.cdc.gov/std/bv/stdfact-bacterial-vaginosis.htm
5 Muzny, C. Sobel, J. (2022) The role of antibiotic resistance in refractory and recurrent bacterial vaginosis and current treatment recommendations. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9024683/
6 Performance of a Vaginal Panel Assay Compared to Clinical Diagnosis (2022). Obstetrics & Gynaecology. https://www.mlo-online.com/molecular/mdx/article/21254666/study-finds-up-to-onethird-of-women-receive-misdiagnosis-of-vaginitis
For Cepheid media inquiries: