Cepheid Announces World Health Organization Prequalification of Xpert HIV-1 Qualitative Test

Point of Care HIV diagnostic testing for infants and early detection of HIV infections 

SUNNYVALE, Calif., April 3, 2024 /PRNewswire/ -- Cepheid today announced that Xpert^® HIV-1 Qual XC has been awarded World Health Organization (WHO) prequalification. Inclusion on the prequalification list signifies that Xpert HIV-1 Qual XC meets WHO's stringent performance, quality, safety and reliability standards. Xpert HIV-1 Qual XC (extended coverage) is an in vitro nucleic acid amplification test for the qualitative detection of HIV-1 total nucleic acids directly from human dried blood spots and capillary or venous whole blood specimens.

Xpert HIV-1 Qual XC provides extended strain coverage by including two gene targets for the identification of HIV-1 infections - delivering results up to seven to ten days before seroconversion. The test has been cleared for use in early diagnosis of infants, adolescents, and adults at the point of care and in laboratories.

Prompt diagnosis and treatment are critical for survival of infants with HIV. Untreated, around 50% of infants infected with HIV during or around the time of birth will die before the age of two years.¹ Although efforts have been made to scale up diagnosis, only around 60% of exposed infants are given an HIV test within the first two months of life.¹ 

"Timing is critical for infants born to mothers living with HIV. When accurate and sensitive test results are provided to clinicians quickly, they can immediately initiate the highly effective therapies that are now available to babies with HIV." said Devasena Gnanashanmugam, M.D. and VP Medical Affairs at Cepheid. "Mothers and families also benefit from the test's quick turnaround time since they have fewer days of anxiety waiting for answers." 

In high-burden regions, centralized laboratory-based infant diagnosis often results in only about half of infants and children living with HIV being linked to and initiated on antiretroviral therapy (ART). Simple point-of-care molecular tests can deliver results to the care giver on the same day, enable earlier linkage to care and initiation of ART, and improve retention in care.²

"Xpert HIV-1 Qual XC leverages dual target technology to improve detection while maintaining the flexibility to be performed on-demand with results in as little as 91 minutes. "said David Persing, M.D., Ph.D., EVP, Chief Medical and Scientific Officer at Cepheid." The combination of peripartum determination of HIV viral load in mothers along with early qualitative HIV detection in newborns facilitates same-day treatment decisions, which will result in improved outcomes for babies, mothers, and entire communities."

The test is designed for use on any of Cepheid's GeneXpert^® systems, which provide simple, reference lab-quality PCR testing on location at medical centers and hospitals or near-patient testing in community health clinics and physician offices.

Xpert HIV-1 Qual XC is part of a comprehensive portfolio of WHO pre-qualified Xpert tests available internationally, including Xpert HIV-1 Viral Load, Xpert HBV Viral load, Xpert HCV Viral Load, Xpert HCV VL Fingerstick, and Xpert HPV, and WHO endorsed Xpert MTB/RIF Ultra and Xpert MTB/XDR. 

For more information on Cepheid's GeneXpert systems or the complete menu of Xpert tests, visit www.cepheidinternational.com. 

CE-IVD. In Vitro Diagnostic Medical Device. May not be available in all countries. Not available in the United States.

About Cepheid
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation's 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 Updated recommendations on HIV prevention, infant diagnosis, antiretroviral initiation and monitoring. Geneva: World Health Organization; 2021 Mar. Accessed Mar 2024. https://www.who.int/publications/i/item/9789240022232 

² Bianchi et al. 2019 Evaluation of a routine point-of-care intervention for early infant diagnosis of HIV: an observational study in eight African countries. Lancet HIV. 2019 Jun;6(6):e373-e381. Accessed Mar 2024. https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(19)30033-5/abstract

For Cepheid Media Inquiries:
Darwa Peterson
[email protected]

SOURCE Cepheid