BioCentury | Jun 22, 2017
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...
...Hologic Inc. (NASDAQ:HOLX), Marlborough, Mass. Product: Aptima HSV 1 & 2 assay Business: Diagnostic Julian Zhu Hologic Inc. Aptima...
BioCentury | Feb 16, 2017
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...
...Mark approval. Hologic Inc. (NASDAQ:HOLX), Marlborough, Mass. Product: Aptima HCV Quant Dx assay Business: Diagnostic Julian Zhu Aptima...
BioCentury | Jan 4, 2017
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...
...Mark approval. Hologic Inc. (NASDAQ:HOLX), Marlborough, Mass. Product: Aptima HIV-1 Quant Dx assay Business: Diagnostic Julian Zhu Aptima...
BioCentury | Sep 12, 2016
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...
...use in CLIA high complexity labs in the U.S. Hologic Inc. (NASDAQ:HOLX), Bedford, Mass. Product: Aptima...
BioCentury | Jun 27, 2016
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...
...use in CLIA high complexity labs in the U.S. Hologic Inc. (NASDAQ:HOLX), Bedford, Mass. Product: Aptima...
BioCentury | Nov 16, 2015
Clinical News

Aptima HCV Quant Dx regulatory update

...Hologic received CE Mark approval for Aptima HCV Quant Dx assay to diagnose HCV infection and...
...serum samples runs on the company’s automated Panther system. Hologic Inc. (NASDAQ:HOLX), Bedford, Mass. Product: Aptima...
BioCentury | Dec 22, 2014
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...
...is designed to run on the company’s Panther system. Hologic Inc. (NASDAQ:HOLX), Bedford, Mass. Product: Aptima...
BioCentury | Nov 18, 2013
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...
...indicated for use with samples from woman who tested positive for HPV infection with Hologic's Aptima...
...ages >=21 years with atypical squamous cells of undetermined significance cervical cytology results. FDA approved Aptima...
BioCentury | Jul 29, 2013
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...
...to detect E6 and E7 mRNA associated with progression of HPV to cervical cancer. The Aptima...
BioCentury | Jun 17, 2013
Company News

Hologic, Quest Diagnostics sales and marketing update

...Hologic's Aptima diagnostic products and to co-develop and promote diagnostics to improve women's health. Hologic's Aptima...
...HPV, HPV genotyping, chlamydia, gonorrhea and Trichomonas vaginalis. Quest already offers in the U.S. Hologic's Aptima...
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