SoleSourceStmt_Aviana_.pdf

NAVAL MEDICAL RESEARCH UNIT SAN ANTONIO

SOLE SOURCE STATEMENT

FY ‘21 Page 1

1. IDENTIFICATION OF THE AGENCY AND THE CONTRACTING ACTIVITY:

This is a Sole Source Statement. Contracting Agency: Naval Medical Research Command (NMRC), 503 Robert Grant Avenue, Silver Spring, MD 20910, acquiring on behalf of Naval Medical Research Unit, San Antonio (NAMRU-SA).

2. NATURE/DESCRIPTION OF CONTRACT ACTION:

Award of a contract on a sole source basis will be made with Aviana Molecular Technologies, LLC to provide a 12-month support and product contract for the development and fabrication of a handheld influenza diagnostic device. Support will be provided for a 12 month base year with no option periods.

Reports and deliverables will be scheduled at designated locations upon order. The proposed source is Aviana Molecular Technologies, LLC (AMT), 6555 Sanger Road, Orlando, FL 32827, USA.

3. DESCRIPTION OF REQUIRED SUPPLIES/SERVICES:

This requirement is for a contract to provide NAMRU-SA with a one-year agreement for the technical and manufacturing/fabrication support in pursuit of a surface acoustic wave (SAW) biosensor coupled with phage display technology. AMT will first metalize the sensing area of the SAW device with a layer of aluminum, then covalently bind influenza A nucleoprotein-binding peptides (peptides produced by NAMRU-SA) to this surface. AMT will then assess the precision and sensitivity of the device response.

AMT will generate a standard curve using different titers of influenza virus load in buffered solution.

AMT will also test influenza virus infused into nasal swab samples to optimize and determine the sensitivity and selectivity of the assay. AMT will calculate assay sensitivity and specificity within 95% confidence intervals. AMT will produce a SAW biosensor based on their current technology with the following alterations a secure packaging that integrates liquid-proof protection by incorporating two air pockets inserted during fabrication. It will protect the transducers and the reflectors from fluid in the sensing area. AMT will integrate this design via a capacitive coupling connection between the SAW sensor and the disposable sensor cartridge support, directly connected to the reader. Deliveries to be scheduled at designated locations upon order. The quoted pricing for this contract is $138,000.00 for one year with no option periods. The total estimated value is $138,000.00.

4. IDENTIFICATION OF THE JUSTIFICATION RATIONALE AND/OR DEMONSTRATION

OF CONTRACTOR’S UNIQUE QUALIFICATIONS:

10 U.S.C. 2304c (1), as implemented by FAR 6.302-1; only one responsible source and no other supplies or services will satisfy agency requirements.

Due to Aviana Molecular Technologies, LLC expertise and patented SAW technology no other business is able to meet the listed requirements. (See accompanying Sole Source Statement from Aviana)

5. MARKET SURVEY/RESEARCH CONDUCTED:

Market research was performed and AMT was contacted via email and video conference. They provided a quote that meets all the above requirements including an initial report on the current status of Aviana’s platform with supporting data as it relates to the virus detection using recognition antibodies, developing a biomolecular coating with anti-influenza A peptides and generate a standard curve using different titers of influenza virus load in buffered solution, and future testing of influenza virus infused into nasal swab samples to optimize and determine the sensitivity and selectivity of the assay. The proposed contract has

NAVAL MEDICAL RESEARCH UNIT SAN ANTONIO

SOLE SOURCE STATEMENT

FY ‘21 Page 2 been synopsized through the FedBizOpps website. No other known sources have expressed an interest, and no other source is expected to express interest in this effort.

6. REMOVE OR OVERCOME BARRIERS TO COMPETITION:

If future requirements exist that do not require the same or similar end results, the government will solicit through full and open competition to remove barriers.

Points of Contact Technical POC Yoon Hwang, Ph.D.

Phone: 210-539-6263 Email: yoon.y.hwang.mil@mail.mil Contract POC Mr. Michael Simonoff Phone: (210) 539-6252 Email: michael.simonoff.civ@mail.mil