Description This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Revolutionary FAR Overhaul (RFO) in Federal Acquisition Regulation (FAR) subpart 12.202, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2025-06. This solicitation is unrestricted. The associated North American Industrial Classification System (NAICS) code for this procurement is 621511, with a small business size standard of $41.5 million. The FSC/PSC is Q301. The VA South Texas Healthcare System at the Audie L. Murphy Memorial Veterans' Hospital, Pathology & Laboratory Medicine Service, 7400 Merton Minter Blvd., San Antonio TX 78229 is requesting brand name or equal Specialized Genetic Laboratory Testing and studies that produce evidence to reduce variants of unknown significance (VUS). All interested vendors shall provide quotations for the following: Line Items 0001, 1001, 2001, 3001, 4001 CancerNext Testing to include genes APC, ATM, AXIN2, BAP1, BARD1, BMPR1A, BRCA1, BRCA2, BRIP1, CDH1, CDKN2A, CHEK2, EPCAM, FH, FLCN, GREM1, HOXB13, MBD4, MET, MLH1, MSH2, MSH3, MSH6, MUTYH, NF1, NTHL1, PALB2, PMS2, POLD1, POLE, PTEN, RAD51C, RAD51D, RPS20, SMAD4, STK11, TP53, TSC1, TSC2, VHL and Line Item 0002, 2001, 2002, 2003, 2004 ColoNext Plus RNA Insight to include genes APC, AXIN2, BMPR1A, CDH1, EPCAM, GREM1, MBD4, MLH1, MSH2, MSH3, MSH6, MUTYH, NTHL1, PMS2, POLD1, POLE, PTEN, RPS20, SMAD4, STK11, TP53, RNA Insight: AIP, ALK, APC, ATM, ATRIP, AXIN2, BAP1, BARD1, BMPR1A, BRCA1, BRCA2, BRIP1, CDC73, CDH1, DK4, DKN1B, CDKN2A, CEBPA, CFTR, CHEK2, CPA1, CTNNA1, CTRC, DX4, DICER1, EGFR, EGLN1, EPCAM, ETV6, FH, FLCN, GATA2, GREM1, HOXB13, KIF1B, KIT, LZTR1, MAX, MBD4, MEN1, MET, MITF, MLH1, MLH3, MSH2, MSH3, MSH6, MUTYH, NF1, NF2, NTHL1, PALB2, PALLD, PDGFRA, PHOX2B, PMS2, POLD1, POLE, POT1, PRKAR1A, PRSS1, PTCH1, PTEN, RAD51B, RAD51C, RAD51D, RB1, RET, RNF43, RPS20, RUNX1, SDHA, SDHAF2, SDHB, SDHC, SDHD, SMAD4, SMARCA4, MARCB1, MARCE1, SPINK1, STK11, UFU, TERT, TMEM127, TP53, TSC1, TSC2, VHL, WT1. The Contractor must provide complementary studies that produce evidence to reduce variants of unknown significance (VUS). The laboratory must be able to provide evidence of supporting variant classifications in the final results report sent to clinicians. The evidence summary must include any significant published literature references as well as internal laboratory data weighted towards the reported classification for full transparency. The Contractor must also perform specialized studies, such as targeted RNA analysis of splicing variants and Ribonucleic Acid (RNA) / Deoxyribonucleic Acid (DNA) tandem analysis, providing the necessary data points to better define whether a VUS is benign (normal variation) or pathogenic (disease-causing). Contractor shall provide the following tests in-house. Test must be brand name or equal to the test description described below. The Laboratory selected is required to be fully licensed, accredited and inspected by the Laboratory Accreditation of an accrediting agency to include College of American Pathologists (CAP) with deemed status from the Center for Medicare and Medicaid Services, Center for Disease Control and any other state regulatory agencies as mandated by Federal and State Statutes. The Laboratory is required to be certified by the Joint Commission, American Associates of Blood Banks (AABB) as applicable. The Clinical Laboratory shall meet all requirements set forth by the Clinical Laboratory Improvement Act (CLIA) of 1988 and comply with the National Standards to Protect the Privacy of Personal Health Information (HIPPA). In addition, contractors must meet all requirements outlined in VHA Directive 1106. These above-mentioned requirements must be met upon the date of Solicitation. The full text of FAR provisions or clauses may be accessed electronically at https://www.acquisition.gov/browse/index/far. Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of RFO FAR 12. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government. Options will be evaluated at time of award. The following are the decision factors: The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors will be used to evaluate offers; Technical Capability Past Performance Price Evaluation Approach. The Government reserves the right to consider a quotation other than the lowest price that provides additional benefit(s). Quotations may exceed minimum requirements of the solicitation. The Government reserves the right to select a quotation that provides benefit to the Government that exceeds the minimum requirements of the solicitation but is not required to do so. Each response must meet the minimum requirements of the solicitation. The Government is not requesting or accepting alternate quotations. Failure to provide the information requested may result in being found non-responsive. The evaluation will consider the following: Technical Capability: Contractor shall clearly demonstrate the ability to meet all requirements in the Statement of Work. Offers will be rated as meets technical factors, exceeds technical factors, does not meet technical factors. Any offer that does not meet the technical factor will not be considered for award. Past Performance: Past performance will be evaluated for past performance using assessment reports in Contractor Performance Assessment Reporting System (CPARS). A review of assessment from the past five (5) years will be used. Vendors with no past performance history will be rated "Neutral" for past performance. Ratings for past performance will be categorized as either Less than Satisfactory, Satisfactory, or Better than Satisfactory. Price: In evaluating the offeror s proposed price for this procurement, the techniques and procedures described under RFO 12.204(a), Price reasonableness. Price will be evaluated for reasonableness, completeness, and fairness by comparing the proposed prices for each period with the prices posed by other offerors and by comparison with the Independent Government Cost Estimate (IGCE). Evaluation of Options. For purposes of award of this Contract, the Government intends to evaluate the option to extend services under FAR 52.217-8 as follows: The evaluation will consider the possibility that the option can be exercised at any time and can be exercised in increments of one to six months, but not for more than a total of six months during the life of the contract. The evaluation will assume that the prices for any option exercised under FAR 52.217-8 will be those rates in effect under the contract each time an option is exercised under this clause. The evaluation will, therefore, assume that the addition of the price or prices of any possible extension or extensions under FAR 52.217-8 to the total price for the basic requirement and the total price for the priced options has the affect the ranking of quotes based on price, unless, after reviewing the quotes, the Government determines that there is a basis for finding otherwise. This evaluation will not obligate the Government to exercise any option under FAR 52.217-8. The award will be made to the response most advantageous to the Government. Responses should contain your best terms and conditions. The following provisions are incorporated into 52.212-1 as an addendum to this solicitation: Technical quotation package shall include sufficient detail and supporting documentation for effective evaluation of offerors abilities at the time of quotation submission. Submit a list of laboratories to include 3rd party laboratories that will be used to perform the testing and analysis / study services. The list must include the laboratory name, address, and CLIA Certification Number. The offeror is required to provide copies of all relevant permits, licenses and certifications of all Contractors and subcontractors upon solicitation. The offeror must submit a quote that clearly shows evidence of the offeror s compliance to meet the minimum requirements set forth herein solicitation. The offeror must clearly demonstrate that the tests and analysis offered are brand name or equal. Contractor shall provide supplies/services as specified in solicitation and the SOW and/or supplies/services listed to include turn-around-time (TAT) that meets the Governments need. If delivery/performance lead time is not provided or deemed unreasonable, quote will be ineligible for award and found technical unacceptable. The offeror must submit a sample of a final report / analysis that supports the requirements of the SOW. Price Quote. The offeror shall submit a fully complete B.3 Price / Cost Schedule. The offeror must complete the vendors test description, vendor test code, firm-fixed-price (FFP) unit and extended price for each line item and the grand total. A vendor produced quote is acceptable as long as it contains all of the information required at B.3 Price / Cost Schedule. The offeror agrees to hold the price in its offer firm for 90 calendar days from the closing date of the solicitation. Technical Question. Technical questions shall be accepted by the Government in writing via email no later than 01/21/2026, at 11:00 AM Eastern Standard Time (EST). Please list Technical Questions 36C25726Q0210, STX Genetic Testing Services in the subject line of the e-mail and send to Kathryn Prose, Contract Specialist, at kathryn.prose@va.gov. Please include in your questions the section of the solicitation/page number that your question is referencing. Offeror shall submit offers by Due Date/Time specified in Block 8 of the Standard Form (SF) 1449 of the solicitation via email to Kathryn Prose at kathryn.prose@va.gov. Please ensure the email subject line states, Quote - 36C25726Q0210, STX Genetic Testing Services Contractor Name . Signed SF-1449. Offeror shall complete blocks 17a and b, and 30a through c of the RFQ, page 1, Standard Form (SF) 1449, and the fill-ins in the B.1 Contract Administration Data section of the solicitation. Exceptions to the solicitation will not be considered for the award.
