Support for pathology and molecular assays

General Information Short Title: Support for pathology and molecular assays Document Type: Presolicitation Notice Solicitation Number: N02CO72727-78 Posted Date: 9/12/2017 Response Date: 9/15/2017 9:00 AM ET Classification Code: B529 NAICS Code: 541990 Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E136, Rockville, MD 20850, UNITED STATES Description National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Infections and Immunoepidemiology Branch(IIB), plans to procure on a sole source basis, services to for the support for pathology and molecular assays from the University of Chicago, 5841 S. Maryland Avenue, Chicago, IL 60637. This acquisition will be processed in accordance with FAR Part 13.106-1 (b)(1)(i). The North American Industry Classification System code is 541990 and the business size standard is $15 million. It has been determined there are no opportunities to acquire green products or services for this procurement. 1) Purpose The purpose of the procurement is to provide support for pathology and molecular assays for 300 patients with oral leukoplakia. Specifically, to provide support for pathology review of hematoxylin & eosin (H&M) stained slides, sectioning of formalin-fixed, paraffin-embedded (FFPE) blocks, DNA extraction from FFPE sections, PCR and sequencing of DNA for the presence of somatic mutations in seven genes known to be frequently altered in oral cancers, and bioinformatics analysis of results. 2) Contract Requirements The Contractor shall perform the following tasks: - Task 1: Study start-up, creation of study protocols, and submission for University of Chicago Internal Review Board (IRB) review/exemption. - Task 2: Pathology review of 300 H&E slides/FFPE blocks and creation of 5 five-micron sections on slides and 10 ten-micron sections in tubes. - Task 3: Extraction of DNA from the ten-micron sections for each of the 300 study subjects. - Task 4: Using the extracted DNA for each of the 300 study subjects, conduct PCR, sequencing, and bioinformatics analyses of the presence of somatic mutations in seven genes (TP53, PIK3CA, CDKN2A, FBXW7, HRAS, NRAS, and FAT-1) and for the presence of HPV infection. 3) Government responsibilities NCI investigators will work with the Contractor to conduct the analyses specified in Tasks 1-4. NCI investigators will provide advice on statistical models and review interim results. 4) Reporting requirements and deliverables Each deliverable shall be provided in electronic form by email to the Technical Point of Contact. Files listing subjects or samples shall be provided as Excel files. Other reports shall be provided as Word documents. Deliverable 1: Corresponding to task 1. Submission of study application to University of Chicago IRB. Due date: One month after start of contract. Deliverable 2: Corresponding to task 2. Shall include a report listing the number of slides and curls created from each of the 300 FFPE blocks. Due date: Four months after start of contract. Deliverable 3: Corresponding to task 3. Shall include a listing of DNA yields from the tissues for each of the 300 study subjects. Due date: Seven months after start of contract. Deliverable 4: Corresponding to task 4. Shall include an excel spreadsheet with masked IDs that correspond to mutational status of each of the 300 study subjects. Due date: 11 months after start of contract. 5) Period of Performance The period of performance is September 30, 2017 through September 29, 2018 6) Payment Schedule The Government will issue payment for each deliverable following acceptance of the deliverable, after the submission of an invoice(s) as per the attached Invoice and Payment Provisions. 7) Inspection and Acceptance Requirements The Government shall have 15 days for the inspection of each deliverable. Unique qualifications The current procurement requires expertise in the handling of FFPE material, including pathology review and sectioning as well as expertise in the development, validation, and molecular and bioinformatic analyses of a panel somatic mutations in genes that are commonly altered in head and neck cancers. Dr. Nishant Agrawal at the University of Chicago is a leading authority in the United States on somatic mutational analysis of oral cancer and has developed a validated panel of somatic mutations that provide a 100% coverage of oral cancers in a US-setting. This panel of somatic mutations is the only validated panel that is currently available in the published literature. All of these features make the University of Chicago the sole source of the current procurement. This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 9 AM ET, on September 15, 2017. All responses and questions must be via email to Francisco Mendoza, Contracting Specialist at francisco.mendoza@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must be registered and have valid certification through SAM.GOV and have Representations and Certifications filled out. Reference: N02CO72727-78 on all correspondence.