Cepheid’s Xpert® Xpress MVP test aids in diagnosing conditions related to vaginitis
Vaginitis and vaginosis are responsible for over 10 million visits per year to physician offices by women in the U.S., making it the most common gynecologic diagnosis in primary care.1
The Xpert® Xpress MVP (multiplex Vaginal panel) test from Cepheid is a new FDA-cleared on-demand PCR test designed to aid clinicians in diagnosing distinct sexually transmitted infections, including bacterial vaginosis (BV), Candida species associated with vulvovaginal candidiasis, and trichomoniasis, that cause overlapping symptoms in women and potential co-occurrence.
“There’s a significant need in the marketplace for this test,” said Cisco Merrill, National Sales Director, Alternate Site for Sunnyvale, Calif.-based Cepheid.
Easy-to-use testing
The test is for patients ages 18 and up.
Its single sample collection is designed to run on the easy-to-use GeneXpert® systems for increased efficiency and to reduce repeat visits. And its easy-to-use testing provides physicians with same-day results for appropriate treatment the first time. There is less than one minute of hands-on time and results within one hour.
“Patients may present with what’s considered cross infections and will test positive for one or two of these different infection states,” Merrill said. “But if a clinic is only testing specifically for one infection state, something may be missed. So, a patient might not get put on a good treatment plan.”
Merrill says this can lead to mistrust for patients.
“It’s a sensitive subject,” he said. “So, the ability to test in-house and meet and treat in one visit is powerful.”
“Our Xpert Xpress MVP test allows clinicians to test for three different infection states,” he continued. “That way, the treatment can align with the ailment. These infection states present similarly but are treated very differently. Getting patients on the right path to recovery is a winning proposition that resonates with our distributor reps and their customers.”
Target markets
Most women depend on their primary care physician or OB-GYN to diagnose vaginitis and vaginosis. But urgent care is also emerging as an alternative market. These markets, as well as labs that reps usually call on, are four primary target markets for the Xpert Xpress MVP test.
“It’s a moderately complex test and we have a very strong program that helps customers transition from waiver to moderate complexity,” Merrill said. “A strategic team will assist throughout the entire licensing process and the team can also work with licensing agencies that assist clinics from waiver to moderately complex.”
Merrill says Cepheid is seeking a CLIA waiver but launched the Xpert Xpress MVP test in the moderately complex category.
Cepheid’s GeneXpert systems and Xpert tests automate highly complex and time-consuming manual procedures for institutions of any size to perform best-in-class PCR testing.