Cepheid Launches Multiplex Vaginal Panel to Support More Accurate Women's Health Diagnosis in U.S.

FDA-cleared PCR test aids in the faster identification of three distinct conditions within an hour

Cepheid announced today that it has launched Xpert Xpress MVP, a multiplexed PCR test which detects DNA from organisms associated with three distinct conditions bacterial vaginosis (BV), vulvovaginal candidiasis, and trichomoniasis from a single sample, aiding in more accurate diagnosis and antibiotic treatment regimens.

Each year, about 10 million healthcare visits by women in the U.S. are related to vaginitis symptoms ¹ . Diagnosis of vaginitis is often made through a clinical examination ² where the physician will prescribe a treatment regimen that may not be targeted to the patients' specific infection type. Sequential treatment failures prolong patient suffering and increase the potential for antimicrobial resistance. Since the causative agents are from three distinct pathogen classes, but present with similar symptoms ³ , a precise diagnosis afforded by multiplexed PCR testing can enable more targeted and timely treatments.

BV is the most common cause of the vaginitis/vaginosis syndrome, but vaginitis can also be caused by Trichomonas and yeasts such as Candida. Antibiotic use is a major factor responsible for Candida overgrowth ⁴ , so identifying the underlying infection is critical to decrease the overuse of antibiotics. The rate of BV recurrence after therapy is high, often greater than 60 percent ⁵ , and compared to a molecular test, empiric approaches can miss 45.3% of positive cases and incorrectly identify 12.3% of negative cases as positives ⁶ .

"Misdiagnosis of the specific underlying causes of vaginitis and vaginosis often lead to inappropriate and ineffective treatments and, in some cases, an increased risk of developing serious complications and antibiotic resistant organisms," said David Persing , M.D., 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 correct treatment regimen, with the goal of avoiding multiple office visits associated with therapeutic failure."

Xpert Xpress MVP aids clinicians in the detection of these infections, including co-occurrences from a single sample with a detection time within 60 minutes, significantly narrowing the test-to-treatment gap and better supporting patient outcomes.

For more information about Cepheid's Xpert Xpress MVP test, please visit Cepheid's website .

Based in Sunnyvale, Calif. , Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation's (NYSE: DHR) Diagnostics platform. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com .

¹ Cammarata, C. L. BS; Stonebraker, E. BS; Eckert, K. MS; Van Der Pol , B. PhD, MPH; Taylor, S. N. MD. (2021) Performance of a Vaginal Panel Assay Compared With the Clinical Diagnosis of Vaginitis. Obstetrics & Gynecology: December 2021 - Volume 138 - Issue 6 - p 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 Antimicrobial Resistance in Refractory and Recurrent Bacterial Vaginosis and Current Recommendations for Treatment. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9024683/
⁶ Performance of a Vaginal Panel Assay Compared With the Clinical Diagnosis (2022). Obstetrics & Gynecology. https://www.mlo-online.com/molecular/mdx/article/21254666/study-finds-up-to-onethird-of-women-receive-misdiagnosis-of-vaginitis

For Cepheid Media Inquiries:
Darwa Peterson
darwa.peterson@cepheid.com

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