Single_Source_Justification_-_xTAG_Redacted.pdf

Single Source Justification (Simplified Acquisition)

Page 1 of 1Updated: 9 Jun 16

Section A: General Contract Information

Contracting Activity: 81 CONS/LGCB

Project/Program Name: XTAG CF 39 KIT V2 96/PK

Purchase Request/Identification Number: FM301092630161

Estimated Contract Cost (including Options):

Section B: Description of the Supplies/Services Required

81 Medical Operations Squadron/Genetics Flight (81 MDOS/SGOU) requests sole source purchase of cystic fibrosis (CF) reagents through Luminex Corporation. These reagents come in one kit, xTAG Cystic Fibrosis CF39v2 Catalog #I027C0231, and are priced at

Section C: Justification for Soliciting from a Single Source or Brand Name xTAG Cystic Fibrosis In Vitro Diagnostic (IVD) assays are designed to detect and identify the most common cystic fibrosis transmembrane conductance regulator (CFTR) mutations and variants. They offer the ability to test for the 23 CFTR mutations recommended by the American College of Medical Genetics/American College of Obstetricians and Gynecologists (ACMG/ACOG), as well as the flexibility to use an expanded panel of CF mutations to obtain broad ethnic coverage across populations. xTAG Technology uses a proprietary universal tag system that allows easy development and optimization of nucleic acid assays. The kits are designed for use with the three existing Luminex analyzers in the lab. IAW FAR 6.302, the statutory authority permitting other than full and open competition for this acquisition is 10 USC 2304(c). The 81 MDOS has performed an Internet marker search which returned three other Food and Drug Administration (FDA) approved testing reagent kits (GenMark, Thermo Fisher, and Kerafast) but only Luminex can meet the current requirement. There is no other company that produces an xTAG CF kit for use with the Luminex, nor does any other company make a CF kit that can be run on these instruments. Market research was performed and currently, there are no other manufacturers with these specific chemistries for cystic fibrosis testing. To use different presently available products would necessitate the purchase of a newer gene analyzer which would cost approximately $156,000.00. If genetics lab is unable to obtain this item, the lab would not be able to analyze 22,883 patient samples, or 63% of the workload will come to a halt, while DoD's cost from outsourcing this test to a civilian facility would be approximately $1.2M.

Section D: Efforts to Obtain Competition

Market research was conducted via the Internet and found that various other vendors such as Thermo Fisher and Invitae can provide cystic fibrosis screening kits. However, only Luminex Corporation's xTAG CF kits can meet this requirement. There is no other company that produces an xTAG CF kit for use with Luminex, nor does any other company make a CF kit that can be run on these instruments. As such, a sole source acquisition from the aforementioned vendor will be completed under a firm-fixed price purchase order. Recommend Other Than Full and Open Competition.

Section E: Steps to Preclude Future Single Source or Brand Name Awards

The 81 MDOS will continue to review and monitor the commercial market to identify other suitable products in the event they become available.

Section F: Contracting Officer's Determination

I have determined, in accordance with FAR 13.106-1(b)(1), that the circumstances of this contract action deem only a single source is reasonably available.

Date

23-Sep-2019

Typed Name and Rank/Grade of Contracting Officer

TIMOTHY M. THULIN, MSgt, USAF

Signature of Contracting Officer

THULIN.TIMOTHY.MICHAEL.10

96909035

Digitally signed by

THULIN.TIMOTHY.MICHAEL.1096909035

Date: 2019.09.23 13:03:10 -05'00'