The Centers for Disease Control and Prevention, Division of Laboratory Sciences (DLS) intends to award a sole source firm-fixed price contract, to procure MiSeq CF clinical sequencing kits to Illumina Inc., 5200 Illumina Way, San Diego CA 92122-4616. The requirement must fulfill the requirement of being a FDA-cleared next generation sequencing assay that works on the MiSeqDx system and makes accurate calls for the polyTG/polyT region in intron 9. Illumina is the only vendor that has the FDA cleared product which complies with the DLS requirements.

Potential vendors should be able to also fulfill the following for MiSeqDx Cystic Fibrosis Clinical Sequencing Assay product:
1. Capture all variants in the coding regions of the CFTR gene as well as intron/exon boundaries, two deep intronic variants and two large deletions.
2. Sequence coverage of a lleast 3000x with a least 99% of accuracy including the polyTG/polyT region.
3. Works with the MiSeqDx instrument.

The statutory authority for this sole source acquisition is U.S.C. 2304 (c) (1) in accordance with FAR Part 6.302-1 only one responsible source and no other supplies or services will satisfy the agency requirements. The NAICS code for this procurement is 325413 IN-VITRO DIAGNOSTIC SUBSTANCE MANUFACTURING with size standard of 1,250 employees.

No solicitation will be posted to FedBizOpps. This notice of intent is not a request for quote. A determination by the government not to compete the proposed purchase order based upon responses to this notice is solely within the discretion of the Contracting Officer.

Interested parties who believe they possess the capability to satisfy this requirement should submit a capability statement demonstrating their ability to meet the requirement. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. All responses should be emailed to Mr. Philip Robinson at [email protected] using solicitation number 2017-Q-66576 in the subject line no later than 11:00 am Eastern Standard Time, September 7, 2017.

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