Notice of Intent: xMAP Multiplex Kits

Added: Jul 27, 2017 2:46 pm This synopsis is hereby issued in accordance with FAR Part 5.203 and FAR 13.501(a) in response to the mandatory requirement for a 15 day notification. The purpose of this synopsis is to announce the Food and Drug Administration's intent to negotiate a Firm Fixed Price sole source contract with RADIX BIO SOLUTIONS, LTD, located at 111 W Cooperative Way, Georgetown, TX 78626-7676 for the purchase of xMAP food allergen multiplex kits.

The Government intends to negotiate solely with Radix Bio Solutions, as no other source of supplies will satisfy agency requirements. This procurement will continue studies awarded under contract # HHSF223201510071A, that provided single lab validation. The purpose of this acquisition is to conduct the studies required to demonstrate the reliability of an xMAP multiplex assay prior to its use in support of the Food Allergen Labeling and Consumer Protection Act of 2004 and the Gluten-Free Regulation of 2013.

The kits to be purchased are the only assay that can simultaneously test for fourteen (14) different food allergens and gluten, with most involving two (2) confirmatory tests. The kits to be acquired have an analytical sensitivity demonstrated to be 1/100th of that reported for other antibody based tests commercially available, filling a critical gap in the methodology employed the Food and Drug Administration in its enforcement of the Food Allergen Labeling and Consumer Protection Act of 2004.

Quantities to be purchased are as follows:

-Fifty-one (51) xMap Assay Kits in 17, 3-Kit Packages.
-Fifty (50) xMap Assay Kits in 25, 2-kit Packages.

THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE PROPOSALS, however, interested firms may submit a capability statement in response to the above requirement with pricing information by August 11th, 2017@ 3:00 PM Eastern Time to Christopher McGucken, Contract Specialist, Phone: (240) 402-7566, Email: Christopher.McGucken@fda.hhs.gov. A determination not to open competition based responses to this notice is solely within the discretion of the Government.