AWARD
A -- A Rapid, Accurate, Disposable Molecular Diagnostic to Detect Influenza and Emerging Infectious Disease, SARS-CoV-2
- Notice Date
- 2/3/2021 6:13:58 AM
- Notice Type
- Award Notice
- NAICS
- 541714
— Research and Development in Biotechnology (except Nanobiotechnology)
- Contracting Office
- ASPR OFFICE OF THE ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE Washington DC 20201 USA
- ZIP Code
- 20201
- Solicitation Number
- 75A50121C00019
- Archive Date
- 02/13/2021
- Point of Contact
- Jeffrey Schmidt, Phone: 2022050260, John Edwards, Phone: 2026912058
- E-Mail Address
-
jeffrey.schmidt2@hhs.gov, john.edwards@hhs.gov
(jeffrey.schmidt2@hhs.gov, john.edwards@hhs.gov)
- Award Number
- 75A50121C00019
- Award Date
- 01/29/2021
- Awardee
- VISBY MEDICAL, INC. San Jose CA USA
- Award Amount
- 48710544.00
- Description
- The overall objective of this contract is to advance the development of a multiplexed, single-use molecular diagnostic test that detects Flu A, Flu B, and SARS-CoV-2 viral RNA from a single nasal swab. The scope of work for this contract includes non-clinical, clinical, CMC, and regulatory activities necessary to take this multiplexed Respiratory Health test through FDA EUA for use in point of care (POC) settings. The assay will be implemented on the Contractor�s Version B platform, which is the lowcost, scalable platform suitable for automated manufacturing. Options are included to take the multiplexed Respiratory Test through to EUA-Over the Counter (OTC), 510k/CLIA-waiver and OTC approvals. Additionally, another Option is included to take the Contractor�s COVID-19 test implemented on the Version B platform through to EUA-OTC. Additionally, the Contractor will complete projects designed to reduce the cost of goods (COGs) such as assessing cheaper Reverse Transcriptase and DNA polymerase enzymes, and value-based engineering on the printed circuit board, plastics, and packaging. Moreover, the Contractor will develop digital assets (Electronic Health Record (EHR) integration and web-based patient portal) to complement the Contractor�s respiratory device and is designed to integrate seamlessly with patient EHRs in point of care settings.�
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/9597ab31b61f400699919e010c7215b7/view)
- Place of Performance
- Address: San Jose, CA 95134, USA
- Zip Code: 95134
- Country: USA
- Zip Code: 95134
- Record
- SN05906571-F 20210205/210203230104 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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