SAMDaily.us | AWARD | A | FDA Submission of IVD Assays and Collection Device for Hologic IVD Panther Fusion SARS-CoV-2/Flu A/B/RSV and IVD Aptima SARS-CoV-2 Assays

SAMDAILY.US - ISSUE OF OCTOBER 02, 2022 SAM #7611
AWARD

A -- FDA Submission of IVD Assays and Collection Device for Hologic IVD Panther Fusion SARS-CoV-2/Flu A/B/RSV and IVD Aptima SARS-CoV-2 Assays

Notice Date: 9/30/2022 8:24:30 AM
Notice Type: Award Notice
NAICS: 541714 — Research and Development in Biotechnology (except Nanobiotechnology)
Contracting Office: BARDA - ASPR / DAAPPO / BARDA DCMA WASHINGTON DC 20515 USA
ZIP Code: 20515
Solicitation Number: 75A50122C00074
Archive Date: 10/29/2022
Point of Contact: Davis Perkins, Amber Gray
E-Mail Address: davis.perkins@hhs.gov, amber.gray@hhs.gov
(davis.perkins@hhs.gov, amber.gray@hhs.gov)
Award Number: 75A50122C00074
Award Date: 09/20/2022
Awardee: Hologic Inc. Marlborough MA 01752 USA
Award Amount: 35600000.00
Description: The purpose is to ensure test availability for SARS-CoV-2 after the emergency authorization closes by submitting an in vitro diagnostic or IVD assay for SARS-CoV-2, influenza (Flu) A, Flu B and Respiratory syncytial virus (RSV) along with a respiratory sample collection device with a nasal claim. Another purpose is to ensure test availability after the emergency authorization is revoked by submitting an IVD assay for SARS-CoV-2 on the Panther system, incorporating a respiratory sample collection device for the assay.
Web Link: SAM.gov Permalink
(https://sam.gov/opp/941ba2b569164959a11723e25a66003b/view)
Place of Performance: Address: Marlborough, MA 01752, USA; Zip Code: 01752; Country: USA
Record: SN06483219-F 20221002/220930230105 (samdaily.us)
Source: SAM.gov Link to This Notice
(may not be valid after Archive Date)

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