Cepheid

Cepheid has received Health Canada medical device licence for Xpert® HIV-1 Viral Load XC, a next-generation molecular test for monitoring HIV viral load levels.

• Cepheid and Oxford Nanopore Technologies have formed a strategic partnership to develop an integrated workflow combining Cepheid's GeneXpert system with Oxford Nanopore's sequencing platform for infectious disease analysis. • The collaboration will initially focus on bacterial and fungal pathogen profiling through whole genome sequencing, with plans to expand into cancer, human genetics, and eventually clinical diagnostics. • The joint solution aims to deliver sequencing results within hours instead of days, making advanced genomic analysis accessible to laboratories without specialized sequencing expertise.

• A new, high-sensitivity HER2 assay developed by Dr. Rimm's lab aims to improve the accuracy and sensitivity of HER2 testing, crucial for identifying patients who may benefit from ADCs. • The assay utilizes immunofluorescence to measure HER2 antibody binding, offering a more quantitative approach compared to traditional methods, potentially increasing sensitivity by tenfold. • Danaher's Beacons program supports the assay's development into a standardized product through collaboration with Leica Biosystems and a clinical trial in partnership with Cepheid. • The clinical trial will assess both the new HER2 assay and Cepheid's STRAT4 assay, which measures HER2 RNA levels, to determine the optimal method for predicting ADC response in breast cancer patients.

• A new point-of-care hepatitis C virus (HCV) RNA assay (Xpert HCV) has shown potential for rapid diagnosis in non-traditional settings, particularly for individuals under community supervision. • The FDA granted marketing authorization for the Xpert HCV test in June 2024, streamlining the HCV testing process and enabling quicker treatment initiation. • Study results demonstrated high sensitivity (96.8%) and specificity (99.4%) of the Xpert HCV test for detecting HCV RNA, confirming its feasibility and accuracy. • The availability of point-of-care testing could allow for same-day initiation of curative HCV treatment, especially benefiting marginalized populations with limited access to care.