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Hologic Gains CE Mark for Aptima HCV Assay

NEW YORK (GenomeWeb) – Hologic today announced it has earned CE-IVD certification for its Aptima hepatitis C virus (HCV) Quant Dx assay.

The transcription-mediated amplification-based assay, which runs on the Panther system, is certified both to confirm active infection in patients with a positive antibody result and to monitor viral load. The firm said in a statement that the assay's limit of detection is 4.3 IU/mL in plasma and 3.9 IU/mL in serum, and its lower limit of quantitation is 10 IU/mL.

In December 2014, Hologic's Aptima HIV-1 assay received the CE Mark. The firm noted that its Aptima HCV and HIV-1 assays are not approved for use in the US.

The Scan

Removal Inquiry

The Wall Street Journal reports that US lawmakers are seeking additional information about the request to remove SARS-CoV-2 sequence data from a database run by the National Institutes of Health.

Likely to End in Spring

Free lateral flow testing for SARS-CoV-2 may end in the UK by next spring, the head of Innova Medical Group says, according to the Financial Times.

Searching for More Codes

NPR reports that the US Department of Justice has accused an insurance and a data mining company of fraud.

Genome Biology Papers on GWAS Fine-Mapping Method, COVID-19 Susceptibility, Rheumatoid Arthritis

In Genome Biology this week: integrative fine-mapping approach, analysis of locus linked to COVID-19 susceptibility and severity, and more.