ThyroSeq Tissue Sample Testing

INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA) on behalf of the on behalf of the National Institute of Digestive, Diabetes & Kidney Diseases intends to award a purchase order without providing for full and open competition (Including brand-name) to CYTOPATH BIOPSY LAB INC for ThyroSeq Tissue Sample Testing. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541380 with a Size Standard of $16.50. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2022-04 Effective January 30, 2022. This acquisition is conducted under the procedures as prescribed in FAR subpart 13'Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000). STATUTORY AUTHORITY This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302- FAR 6.302-1'Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1). PERIOD OF PERFORMANCE Base Year: May 16, 2022 - May 15, 2023 Option Year 1: May 16, 2023 - May 15, 2024 Option Year 2: May 16, 2024 - May 15, 2025 Option Year 3: May 16, 2025 - May 15, 2026 Option Year 4: May 16, 2026 - May 15, 2027 Place of Performance National Institutes of Health National Institute of Digestive, Diabetes & Kidney Diseases 10 Center Drive Bethesda, MD 20892 ? DESCRIPTION OF REQUIREMENT Thyroid cancer is the most common endocrine malignancy. The incidence rate is rising faster than any other type of cancer, and it has a slowly increasing mortality rate. This phenomenon is likely due to the combination of two factors: (1) increase in imaging studies of the neck, leading to incidental discovery of thyroid nodules; (2) environmental factors, such as nuclear reactor accidents, and epidemy of obesity likely leading to a true increase in thyroid cancer incidence. It is important to differentiate an indolent disease course from a highly aggressive thyroid cancer to tailor therapeutic modalities towards avoiding over-treatment in low-risk patients and implementing effective targeted therapies for high-risk patients. Therefore, our scientific interest involves translational and clinical studies focused on both the optimization of thyroid nodules and thyroid cancer diagnosis, as well as appropriate risk stratification and therapy aimed at improving patients morbidity and mortality. _________________________ PURPOSE AND OBJECTIVES Thyroseq helps determine if thyroid nodules that have indeterminate cytology per the biopsy (meaning could be either benign or cancerous) are more likely to be benign or malignant. Hence, Thyroseq adds to the diagnostic procedure and decision-making process about referral for the surgery or not. The aim is to avoid unnecessary overtreatment of benign nodules and under-treatment for malignant nodules. By testing our patient tissue we can provide better standard of care treatments to our clients. SALIENT / REQUIRED FEATURES AND SPECIFICATIONS - Clinically proven method of testing thyroid samples to assist with clinical diagnosis and treatment options for cancers. - Defined protocol for clinicians - Ability to provide quick turnaround on samples so as not to delay critical care decisions TASKS AREAS Independently, and not as an agent of the Government, the contractor shall perform all of the detailed Task Areas listed below: Task Areas: Tissue samples will be collected by NIH and submitted in accordance with the protocol established by Thyroseq for this featured testing. Task Area 1 - Storage instructions before tissue collection: Thyroseq Preserve solution is light sensitive, always store vials in a dark place (inside the collection kit transport box or dark bag) and at room temperature (+15 to +25'C) until expiration date. Task Area 2 - The NIDDK Lab is responsible for labeling the Thyroseq vial with the patient's name and specimen site using labels from the test requisition form. Task Area 3 - storage instructions for after sample collection: 1. No longer than 3 hours at room temperature (i.e.,+15 to 25'C) 2. No longer than 24 hours at +2 to +8'C (i.e., in a refrigerator) 3. Up to 12 months at -15 to -25'C (i.e., in a freezer) Task Area 4 - Shipping Instructions are: 1. Ensure that all vials, tubes, and slides are labeled with at least two unique patient identifiers. 2. Place the Thyroseq specimen vial(s) that are inside the dark bag in the bio-hazard bag along with a flat frozen cold pack, then place the specimen inside the foam insert in the transport kit along with all other tubes and slides used for specimen collection. 3. Include a completed test requisition and a copy of the cytopathology or surgical report for each sample. 4. Call for courier/ carrier pick-up. Task Area 5 - For Thyroid FNA Cytology smears: Results emailed to Project Manager. 1. 1-2 slides with at least 200-300 cells are required. 2. Diff-Quik and Papanicolau (PAP) stained smears are acceptable. Pap-stained smears are preferred. If the above conditions are met, there is a 79-93% success rate of testing2. An increased turnaround time by 2-3 days should be expected for processing cytology smears. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10'Market Research. Only one source is available: Per FAR 13.106-1(b)(1) the Contracting Officer has determined CYTOPATH BIOPSY LAB INC to be the only reasonable available source to provide ThyroSeq Tissue Sample Testing. This acquisition was pursued on a sole source basis centered on the following. The Thyroseq test is proprietary and only available through Cytopath Biopsy Lab. The sequencing and methods used are unique on the market and Cytopath is the only laboratory utilizing this test. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties bona-fide capabilities for fulfilling the requirement and include: descriptive literature, delivery timeframe, warranties and/or other information that demonstrates that the offer meets all the foregoing requirements, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Wednesday, March 30, 2022 to the Contract Specialist, Amber Harris, at contact@example.gov . Assessment of Capability Lowest Price Technically Acceptable