23:31 , Jun 22, 2017 |  BC Week In Review  |  Clinical News

FDA approves Hologic's Aptima HSV 1 & 2 assay

FDA approved the Aptima HSV 1 & 2 assay from Hologic Inc. (NASDAQ:HOLX) to diagnose and differentiate HSV-1 and HSV-2 infection. The...
20:31 , Feb 16, 2017 |  BC Week In Review  |  Clinical News

Aptima HCV Quant Dx assay regulatory update

FDA approved a PMA for Hologic’s Aptima HCV Quant Dx assay to diagnose HCV infection and monitor viral load. The...
22:20 , Jan 4, 2017 |  BC Week In Review  |  Clinical News

Aptima HIV-1 Quant Dx assay regulatory update

FDA approved a PMA for Hologic’s Aptima HIV-1 Quant Dx assay for the quantitative detection of HIV-1 RNA from plasma. The...
07:00 , Sep 12, 2016 |  BC Week In Review  |  Clinical News

Aptima Zika Virus assay regulatory update

FDA expanded the emergency use authorization (EUA) for Hologic’s Aptima Zika Virus assay for in vitro qualitative detection of RNA from the Zika virus to include urine samples. The EUA previously covered the assay’s use...
07:00 , Jun 27, 2016 |  BC Week In Review  |  Clinical News

Aptima Zika Virus assay regulatory update

FDA granted emergency use authorization (EUA) to Hologic’s Aptima Zika Virus assay for in vitro qualitative detection of RNA from the Zika virus in serum or plasma. The transcription-mediated amplification test is authorized for use...
08:00 , Nov 16, 2015 |  BC Week In Review  |  Clinical News

Aptima HCV Quant Dx regulatory update

Hologic received CE Mark approval for Aptima HCV Quant Dx assay to diagnose HCV infection and monitor viral load. The in vitro nucleic acid amplification test to detect and quantify HCV RNA in plasma or...
08:00 , Dec 22, 2014 |  BC Week In Review  |  Clinical News

Aptima HIV-1 Quant Dx assay regulatory update

Hologic received CE Mark approval for its Aptima HIV-1 Quant Dx assay to diagnose HIV-1 infection and monitor viral load. The in vitro nucleic acid amplification test to detect and quantify HIV-1 RNA is designed...
08:00 , Nov 18, 2013 |  BC Week In Review  |  Clinical News

Aptima HPV 16 18/45 Genotype Assay regulatory update

Hologic said FDA approved the Aptima HPV 16 18/45 Genotype Assay for use on Hologic's fully automated Panther system to detect the presence of HPV genotypes 16, 18 and/or 45 infection. The assay is indicated...
07:00 , Jul 29, 2013 |  BC Week In Review  |  Clinical News

Aptima HPV assay regulatory update

Hologic said FDA approved the Aptima HPV assay for use on Hologic's fully-automated Panther system to detect 14 high-risk strains of HPV associated with cervical cancer and precancerous lesions. Specifically, the Aptima HPV assay is...
07:00 , Jun 17, 2013 |  BC Week In Review  |  Company News

Hologic, Quest Diagnostics sales and marketing update

The partners entered a five-year, non-exclusive deal to allow Quest to offer a broader range of Hologic's Aptima diagnostic products and to co-develop and promote diagnostics to improve women's health. Hologic's Aptima products include FDA-approved...