Clinical Study Shows Xpert® Xpress MVP Delivers Appropriate Treatment More Often to Women with Vaginal Symptoms

SUNNYVALE, Calif., July 7, 2026 /PRNewswire/ -- Cepheid, a Danaher company and a leader in molecular diagnostics, today announced the publication of a study demonstrating the real-world impact of the Xpert Xpress MVP (multiplex vaginal panel) test when used at the point of care. The study showed that significantly more women with vaginitis symptoms (e.g., abnormal discharge, odor, itching, or discomfort) received appropriate treatment within 24 hours of their clinic visit when tested with Xpert Xpress MVP compared to standard diagnostic methods. Standard methods are still common in clinical practice and include symptom-based assessment and microscopy.

This study is the first randomized clinical trial to evaluate the utility of a multiplex molecular test for vaginitis at the point of care. The research was led by investigators at Magee-Womens Research Institute and the University of Pittsburgh and was supported by an investigator-initiated grant from Cepheid.

Key Study Findings

• 89.6% of women tested with Xpert Xpress MVP received appropriate treatment within 24 hours of their clinic visit compared to 51.9% with usual care (p < 0.001)
• Among symptomatic women confirmed with no infection, 50% in the usual care arm received unnecessary antimicrobial treatments compared to 27.1% in the Xpert Xpress MVP arm (p = 0.031)
• Most healthcare providers in the study with patients randomized to Xpert Xpress MVP were satisfied with the turnaround time and workflow

Limitations of Current Diagnostic Practices

Women presenting with vaginal infections with overlapping symptoms such as abnormal discharge, itching, or irritation are frequently treated based on nonspecific signs, visual assessment, or wet mount microscopy, which can be subjective.

This study provided insight into real-world diagnostic practices for vaginitis. The investigators reported that 25% of providers relied solely on symptoms to guide treatment decisions, and standard approaches correctly identified infections only about 50–63% of the time. These findings reinforce longstanding challenges associated with microscopy-based diagnosis, including inconsistent use and variable accuracy.

Significant Improvement in Appropriate Treatment

Overall, women tested with Xpert Xpress MVP were significantly more likely to receive appropriate treatment within 24 hours than those receiving usual care.

Findings also highlighted the risk of overtreatment in routine care. Among women with no detectable vaginal pathogens, 50.0% received inappropriate and unnecessary treatment with usual care compared to 27.1% of those tested with Xpert Xpress MVP.

"Overuse of antimicrobials when no pathogens are detected should be avoided since it can contribute to antimicrobial resistance, may disrupt the vaginal microbiome, may cause side effects and adds costs to women and their insurers," the study authors noted.

The majority of healthcare providers who experienced Xpert Xpress MVP reported positive perceptions of the test, with 87% indicating they would like to incorporate this type of testing into routine clinical practice.

Supporting Evidence-Based Care in Women's Health

Commenting on the findings, Connie Savor, MD, Chief Medical Officer at Cepheid, emphasized how access to rapid, on-demand molecular results can improve treatment decisions at the point of care.

"Women presenting with vaginal symptoms deserve accurate answers and timely, evidence-based care," said Dr. Savor. "This study demonstrates how molecular point-of-care tests, such as Xpert Xpress MVP, can help clinicians make more informed treatment decisions in a single visit, improving care while reducing unnecessary treatment."

Given that vaginal symptoms are often nonspecific and may occur in women without infection, the findings highlight the limitations of symptom-based management and the value of fast, accurate diagnostics at the point of care.

IVD. In vitro diagnostic medical device. Not available in all countries.

Reference
Hillier SL et al. 2026. Randomized Study of Usual Care vs Xpert^® Xpress MVP at the Point of Care for Accurate Diagnosis and Appropriate Treatment of Vaginal Infections. Sexually Transmitted Diseases ():10.1097/OLQ.0000000000002343, May 12, 2026. | DOI: 10.1097/OLQ.0000000000002343 Sexually Transmitted Diseases

About Xpert Xpress MVP

Xpert Xpress MVP (multiplex vaginal panel) is an FDA-cleared, CLIA‑waived PCR test. Using a single vaginal swab specimen (clinician- or self-collected in a clinical setting), the test detects the causative agents of bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis, including co-infections, in women 14 years old and over. The test runs on Cepheid's GeneXpert and GeneXpert Xpress systems and provides results in approximately 1 hour. Learn more.

About Cepheid
Cepheid, a Danaher company and a leader in molecular diagnostics, is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. Cepheid's GeneXpert^® systems and Xpert^® tests automate highly complex and time-consuming manual procedures, providing A Better Way for institutions of any size to perform world-class PCR testing. Cepheid's broad test portfolio spans respiratory infections, blood virology, women's and sexual health, TB and emerging infectious diseases, healthcare-associated infectious diseases, oncology, and human genetics. The company's solutions deliver actionable results where they are needed most—from central laboratories and hospitals to near-patient settings. For more information, visit http://www.cepheid.com.

About Danaher
Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health. Through our connected ecosystem of industry-leading businesses, we work side by side with customers to solve their most complex scientific and clinical challenges—helping move innovations from discovery to delivery faster for patients who depend on them. Powered by the Danaher Business System, our advanced science and technology and proven ability to innovate help enable faster, more accurate diagnoses and reduce the time, cost, and risk required to discover, develop, and deliver life-changing therapies. Through continuous improvement and operational excellence, our approximately 60,000 associates worldwide are focused on delivering lasting impact and improving quality of life around the world, while building a healthier, more sustainable tomorrow. Explore more at www.danaher.com.

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SOURCE Cepheid