Cepheid Receives CE-IVD Clearance for Two Next-Generation Xpert® HIV-1 Tests

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Jul 29, 2021, 07:00 ET

SUNNYVALE, Calif., July 29, 2021 /PRNewswire/ -- Today Cepheid announced that it has received CE-IVD clearance for Xpert^® HIV-1 Viral Load XC and Xpert^® HIV-1 Qual XC, next-generation extended-coverage (XC) tests for HIV testing.

Xpert^® HIV-1 Viral Load XC adds a second target for HIV-1 detection that provides extended strain coverage to improve performance and address the risk of false negative results due to gene mutations or deletions. Xpert^® HIV-1 Viral Load XC is intended to assess viral load levels, which are used to monitor effectiveness of antiretroviral treatment.

Xpert^® HIV-1 Qual XC also adds a second target for early identification of HIV-1 infections up to 7-10 days before seroconversion. The test has been cleared for use with infants, adolescents, and adults in both laboratory and near-patient testing environments. With all reagents on board in one fully integrated cartridge, Xpert HIV-1 Qual XC facilitates dried blood spot (DBS) sample processing and a simplified workflow. Finally, Xpert HIV-1 Qual XC does not contain guanidinium thiocyanate (GTC), making cartridge disposal simpler and more environmentally friendly.

"Xpert^® HIV-1 Viral Load XC and Xpert^® HIV-1 Qual XC leverage new dual target technology to improve detection while maintaining the flexibility to be performed on-demand in as little as 90 minutes." said Dr. David H Persing, Executive Vice President and Chief Medical and Technology 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."

Both tests are 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.

Cepheid will start shipping the new kits to countries accepting CE-marked products at the end of July. Both Xpert HIV-1 Viral Load XC and Xpert HIV-1 Qual XC will undergo WHO pre-qualification assessment, aiming for pre-qualification in 2022.

About Cepheid
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company. 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 molecular diagnostic 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.

For Cepheid Media Inquiries:
Darwa Peterson
[email protected]

Jason Spark, CanaleComm
[email protected]

SOURCE Cepheid