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Tag Archives: Hologic—

Hologic adds Open Access functionality to Panther Fusion

Nov. 13, 2018—Hologic announced the availability of Open Access functionality for its Panther Fusion system. The enhanced functionality will allow CLIA-certified laboratories to develop laboratory-developed tests to run on the fully automated Fusion platform. Laboratories will be able to run their LDTs simultaneously with commercially available IVD assays, and results will release automatically to laboratory information systems. “We know that ...

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Panther Fusion GBS assay cleared

October 2018—Hologic received FDA clearance for its group B Streptococcus assay on the Panther Fusion system. The Panther Fusion GBS assay is a real-time PCR assay for the qualitative detection of group B strep in antepartum women with dual-target detection of Cfb and SIP genes.

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Health Canada approves Panther Fusion

August 2018—Hologic has obtained approval from Health Canada for its Panther Fusion system and Panther Fusion assays for respiratory virus infections. The Panther Fusion module adds the capacity to run PCR assays in addition to tests based on transcription-mediated amplification, the proprietary Hologic chemistry that powers the company’s Aptima brand.

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FDA OKs ThinPrep Integrated Imager

May 1, 2018—Hologic has received FDA premarket approval for its Hologic ThinPrep Integrated Imager. The company says the Integrated Imager combines the power of ThinPrep computer-assisted imaging and the ease of dual slide review into a single, automated microscope. “Approval of the ThinPrep Integrated Imager brings the benefits of ThinPrep automated Pap imaging to small- and mid-sized laboratories in the United ...

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Aptima HBV Quant Assay gets PMA approval

Jan. 30, 2018—Hologic announced the FDA has granted PMA approval for the Aptima HBV Quant Assay for quantitation of hepatitis B viral load on the Panther system. The Aptima HBV Quant assay is the newest addition to the Panther system’s viral load menu, joining the previously approved Aptima HIV-1 Quant Assay and Aptima HCV Quant Dx Assay. The three assays ...

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FDA clears third Panther Fusion assay

Dec. 6, 2017—Hologic announced that it has received FDA 510(k) clearance for its Panther Fusion AdV/hMPV/RV assay running on the Panther Fusion system. The assay detects adenovirus, human metapneumovirus, and rhinovirus. The Panther Fusion assays, which also include the Panther Fusion Flu A/B/RSV assay and the Panther Fusion Paraflu assay, offer a modular approach to syndromic respiratory testing via the ...

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