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MARLBOROUGH, Mass., Nov. 10, 2016 /CNW/ — Hologic, Inc. (Nasdaq: HOLX) announced today that it has obtained approval from Health Canada for the Company’s hepatitis C and B assays.
The Aptima® HCV and HBV Quant assays are nucleic acid amplification tests for the quantitative detection of RNA from hepatitis C, and DNA from hepatitis B-infected patients. These assays supplement the already available Aptima HIV-1 Quant assay, rounding out the Company’s virology portfolio on the Panther® system in Canada.
The Aptima HCV and HBV Quant assays provide excellent performance in sensitivity and precision parameters, along with sample-to-result automation on the Panther system. Both assays provide coverage across a wide linear range and employ multiple layers of protection for viral detection and quantitation across all major genotypes.
[Note from CDM: The Aptima HCV Quant Dx assay’s Limit of Detection (LoD) is 4.3 IU/mL in plasma (3.9 IU/mL in serum) – which is slightly lower than transcription-mediated amplification (TMA) testing, which use to be the lowest.]
Read complete press release here: http://www.newswire.ca/news-releases/hologic-obtains-canadian-approval-for-aptima-hepatitis-c-and-b-quant-assays-600669411.html