SPECIAL NOTICE
W -- Notice of Intent to Sole Source Sentosa SQ HIV Genotyping Assay
- Notice Date
- 8/23/2021 11:24:23 AM
- Notice Type
- Special Notice
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- W4PZ USA MED RSCH ACQUIS ACT FORT DETRICK MD 21702-5014 USA
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-21-JC-82321
- Response Due
- 9/7/2021 12:00:00 PM
- Archive Date
- 09/22/2021
- Point of Contact
- James Cheng, Phone: 3016191012
- E-Mail Address
-
james.cheng1.civ@mail.mil
(james.cheng1.civ@mail.mil)
- Description
- This notice announces the intent by the U.S. Army Medical Research Acquisition Activity (USAMRAA) in support of the Walter Reed Army Institute of Research (WRAIR) to�procure a Sentosa SQ HIV Genotyping Assay without competition as prescribed in FAR 13.501(a)(1)(ii). Specifically, the Government will procure this from Vela Diagnostics There are only two FDA approved HIV genotyping platforms with associated assays, the newly approved next generation Vela Sentosa SQ Next Generation System (NGS) and the 20 year old ViroSeq platform, by Abbott Laboratories. HIV Diagnostic Reference Lab (HDRL) currently uses the ViroSeq platform/assay which has consistently failed performance criteria and requires execution of two separate assays for determination of drug resistance to HIV anti-viral drugs. This assay is programmed to be discontinued by Abbott by Dec 2021, or sooner since most labs are experiencing very high number of failed test runs on the platform. DCB has not been able to meet its mandated College of American Pathologist (CAP) test turnaround times with the Abbott VeriSeq assay over a period of months. Since HDRL provides HIV resistance genotype testing, i.e., monitors whether a Service Member's viral infection is sensitive to the drugs he/she is taking, for all DoD wide HIV infected Service Members, it is critical DCB pivots to a reliable system which will meet DoD requirements. The Vela System is the only FDA approved next generation genotype system, it combines two assays into one; will permit test-turn-around times to within three days of receipt - 5-fold faster than DCB�s current 20 year old genotyping platform.� VELA is the manufacturer of the Sentosa system and to ensure the continuation of critical HIV genotype testing, WRAIR must obtain the required system, installation, training and maintenance from the manufacturer. Competition would not have been feasible had more time been available, since VELA owns the technology patents and is the sole manufacturer of the Sentosa System that provides the requisite testing, as the other prospective vendor�s technology will be phased out no later than December 2021. This system is critical for HDRL, DCB to provide HIV-1 drug resistance testing results to Military Testing Facilities for use by physicians in the treatment of HIV-1 positive soldiers and their beneficiaries.� The test results indicate sensitivity or resistance to various anti-retroviral drugs and are used by physicians to select the appropriate drugs to prevent HIV-1 viral replication such that the virus is not detectable in the blood and thus, is not transmissible, preventing new infections and advancement to disease state, AIDS. This announcement fulfills the synopsis requirements under FAR 5.102(a)(6) and 5.203(a). USAMRAA intends to publish a solicitation no sooner than 15 days after publishing this synopsis. This Special Notice of Intent is not a request for competitive quotes. Information received in response to this notice will be considered solely for the purpose of determining whether a competitive procurement is in the best interest of the Government. If no written responses are received by the date listed below, which reflects at least fifteen (15) days after the publication of this notice, the solicitation will be issued as sole source requirement. All questions and responses concerning this notice shall be emailed to James Cheng at james.cheng1.civ@mail.mil. Interested concerns must identify their capability in writing to the above email address listed above no later than 3:00 PM ET,�7 Sept 2021.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/846e0df049ba4c3289eb42e574c4cd3d/view)
- Place of Performance
- Address: USA
- Country: USA
- Country: USA
- Record
- SN06106602-F 20210825/210823230118 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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