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Cepheid Nabs CE Mark for PCR-Based HIV-1 Tests

NEW YORK – Danaher subsidiary Cepheid announced on Thursday that two of its PCR-based tests for HIV-1 have received CE-IVD marking.

The Xpert HIV-1 Viral Load XC and Xpert HIV-1 Qual XC are next-generation extended-coverage tests for HIV and can run on any of the firm's GeneXpert instruments, the company said in a statement.

The viral load test adds a second target for detection to provide extended strain coverage, which will improve performance and address the risk of false negative results because of gene mutations or deletions. By determining viral load levels, clinicians can monitor the effectiveness of antiretroviral treatment.

The Xpert HIV-1 Qual XC test also adds a second target for early identification of the disease seven to 10 days before seroconversion. All reagents are on one integrated cartridge, facilitating dried blood spot sample processing and a "simplified workflow," the company said. The cartridge doesn't contain guanidinium thiocyanate, which makes it easier to dispose of and more environmentally friendly. It has been cleared for use with infants, adolescents, and adults in laboratory and near-patient settings.

Sunnyvale, California-based Cepheid said it will begin shipping the kits to countries accepting the CE mark at the end of July. It will also undergo pre-qualification assessment from the World Health Organization, aiming for pre-qualification in 2022.

The tests "leverage new dual target technology to improve detection while maintaining the flexibility to be performed on demand in as little as 90 minutes," David Persing, executive VP and chief medical and technical officer at Cepheid, said in a statement.

"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," he added.