CLIA-certified clinical genetic testing for TP53

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E626, Bethesda, MD 20892, UNITED STATES. Non-USPS mail such as Fedex, UPS and other private carriers please use Rockville, MD 20850. This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation: No. N02CP52612-24 includes all applicable provisions and clauses in effect through FAR FAC 2005-82 (May 2015) simplified procedures for commercial items. Only one award will be made as a result of this solicitation. This will be awarded as an Indefinite Delivery, Indefinite Quantity with firm fixed price task orders issued as needed. Period of performance of five years. I. Description of Requirement The National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Clinical Genetics Branch (CGB), intends to procure CLIA-certified clinical genetic testing for TP53. Li-Fraumeni syndrome (LFS) is a rare, dominantly-inherited, cancer predisposition syndrome that is characterized by early-onset of multiple specific cancers and very high lifetime cumulative cancer risks. Germline mutations in the TP53 gene have been identified to be the underlying molecular etiology of LFS. Clinical genetic testing for TP53 is available, and is recommended for families meeting clinical criteria for mutation testing, and for at-risk individuals from families in which a TP53 mutation has been identified. One important aspect of the Clinical Genetics Brach (CGB) study NCI Protocol# 11-C-0255 "Clinical, Epidemiologic, and Genetic Studies of Li-Fraumeni Syndrome" is to estimate more precisely risk of various cancers in TP53 mutation carriers and to provide genetic counseling and testing to participants when appropriate. Over the course of one calendar year, we anticipate ordering approximately 10-15 full testing assays (TP53 full gene sequencing (p53-SEQ) +/- TP53 gene, MLPA analysis (p53-DEL)) on study participants from families in which the TP53 mutation status is unknown and 20-25 study participants from families with known TP53 mutations, for family-specific mutation testing. The family specific mutation can be a small change (TP53 gene, targeted mutation analysis, known mutation, or p53-CAS) or a large rearrangement (TP53 gene, MLPA analysis, known deletions/duplications, or p53-DEL-CAS). NCI will provide the contractor will the following samples: - Blood samples: 2 tubes with a total of 6 cc in ACD (yellow top) or EDTA (lavender top) tubes. Blood will be kept at ambient temperature and ship by overnight courier. For young children, only 3cc of blood will be sent, or - 10 microgram of extracted DNA The contractor shall perform TP53 genetic testing, including sequencing and testing for large rearrangements, to identify any functionally relevant variants. For individuals from families in which no TP53 testing had been done, the contractor will start with performing full-sequencing, and if no mutation is found, will follow with MLPA analysis to look for large rearrangement. For individuals from families in which a TP53 mutation has been previously identified, the contractor will perform either single site testing or MLPA, depending on the nature of the known mutation. A. Sequencing: 1) For full-gene testing (p53-SEQ), sequencing of all coding exons (exon2 through exon11) and associated intron junctions of the TP53 gene will be analyzed by direct DNA sequence analysis, using an automated fluorescent sequencing machine. When a mutation is detected, confirmation will be carried out on an independent amplification of PCR, using a second sample prep (the "B-prep") by sequencing in the opposite direction. If no mutation is found, sequence analysis is performed in both directions. 2) For single site mutation-specific testing (p53-CAS), sequence analysis of only the amplicon containing the specific mutation will be carried out. B. MLPA analysis: 1) Full large rearrangement testing (p53-DEL) will be performed using the SALSA Multiplex Ligation-Dependent Probe Amplification (MLPA) kit, which contains probes for each of the 11 exons of the TP53 gene, as well as several probes at close distances telomeric and centromeric of the TP53 gene, as well as two probes for detecting sequences in exon 1 of TP53. 2) For known large rearrangement testing (p53-DEL-CAS), same testing using the SALSA Multiplex Ligation-Dependent Probe Amplification (MLPA) kit will be performed. For result reports, the contractor shall provide detailed interpretations of any relevant variant and categorize findings into one of five categories: - Positive, predicted to be deleterious - Variant, likely to be deleterious - Variant of uncertain significance - Variant, unlikely to be deleterious - Negative, no variant of likely functional significance was detected. II. Delivery: The contractor shall deliver result reports to NCI within 4-8 weeks of sample receipt III. Payment: Payment will be made when the test has been completed and the test report with its associated invoice is received by NCI. Payment authorization requires submission and approval of invoice to the NCI COR and NIH Commercial Accounts. QUOTATIONS ARE DUE: July 7, 2015 PROVISIONS AND CLAUSES: The following FAR provisions and clauses apply to this acquisition: FAR clause 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS (July 2013); FAR clause 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS- (March 2015) WITH DUNS NUMBER ADDENDUM {52.204-6 (July 2013)}; FAR Clause 52.212-4 CONTRACT TERMS AND CONDITIONS - COMMERCIAL ITEMS (December 2014); FAR Clause 52.212-5: CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (March 2015). The following FAR clauses cited in paragraph (b) of the clause at FAR 52.212-5 are also applicable to this acquisition; FAR Clause 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards FAR Clause 52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment FAR Clause 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns FAR Clause 52.219-28 Post Award Small Business Program Representation FAR Clause 52.222-3 Convict Labor FAR Clause 52.222-19 Child Labor-Cooperation with Authorities and Remedies FAR Clause 52.222-21 Prohibition of Segregated Facilities FAR Clause 52.222-26 Equal Opportunity FAR Clause 52.222-35 Equal Opportunity for Veterans FAR Clause 52.222-36 Affirmative Action for Workers with Disabilities FAR Clause 52.222-37 Employment Reports on Veterans FAR Clause 52.223-18 Contractor Policy to Ban Text Messaging while Driving FAR Clause 52.225-13 Restrictions on Certain Foreign Purchases Far Clause 52.232-33 Payment by Electronic Funds Transfer-System for Awards Management (SAM) Full text copies of the representations and certifications for other cited provisions and clauses may be obtained on line at the NCI website at http://ncioa.cancer.gov/oa-internet/ or from Kimesha Leake, Contract Specialist at contact@example.gov OFFERORS: Offers must be submitted on an SF-1449 with a completed 52.212-3 Offeror Representations and Certifications-Commercial Items-with DUNS Number Addendum, signed by an authorized representative of the offeror OR provide a copy of the valid certification registrations of the offeror's System for Award Management (SAM) through sam.gov. Quotations must be received in the NCI-OA contracting office by 7/7/15. Please refer to solicitation number N02CP52612-24 on all correspondence. No collect calls will be accepted. Faxed or electronic mail quotations will be accepted. All questions shall be in writing and may be addressed to the aforementioned individual noted above. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management through sam.gov.