SOLICITATION NOTICE
Q -- Renal Cell Carcinoma Genome-Wide Association Study: Extraction of Germline DNA Samples from Fox Chase Cancer Center Biobank
- Notice Date
- 7/13/2018
- Notice Type
- Presolicitation
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02CP82593-24
- Archive Date
- 8/14/2018
- Point of Contact
- Kimesha Leake, Phone: 2402765669, Reyes Rodriguez, Phone: 240-276-5442
- E-Mail Address
-
kimesha.leake@nih.gov, reyes.rodriguez@nih.gov
(kimesha.leake@nih.gov, reyes.rodriguez@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E134, Bethesda, MD 20892, UNITED STATES Description The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG) plans to procure on a sole source basis services to analyze DNA samples stored at the biobank of the Fox Chase Cancer Center from The Institute for Cancer Research, 333 Cottman Avenue, Philadelphia, PA 19111-2434. This acquisition will be processed in accordance with the simplified acquisition procedures as authorized by FAR Part 13.106-1 (b) (1) and is exempt from the requirements of FAR part 6. The North American Industry Classification System Code is 541380 and the business size standard is $15.0 million. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The period of performance shall be August 20, 2018 through August 19, 2019. It has been determined there are no opportunities to acquire green products or services for this procurement. BACKGROUND There is clear evidence that genetic factors influence susceptibility to renal cell carcinoma (RCC), with very high rates of RCC observed among patients with von Hippel-Lindau (VHL) syndrome and other genetic disorders, including hereditary papillary renal cell carcinoma and Birt Hogg Dubé syndrome. However, such familial cases represent a miniscule fraction of overall cases. The contributions of common low-penetrance genetic variants to RCC heritability have become increasingly apparent through genome-wide association studies (GWAS), several of which have been conducted by investigators at the National Cancer Institute (NCI). It is likely that only a small fraction of common genetic loci affecting RCC risk have been identified to date. In a recent NCI-led GWAS analysis, it was estimated that the total number of RCC loci identified to date explain approximately 10% of disease heritability, suggesting that many more risk variants remain to be discovered. To better understand the role of common genetic variation in RCC susceptibility, NCI is genotyping additional RCC cases to expand the size of its GWAS. This expanded GWAS will comprehensively identify common risk variants with moderate effect sizes, identify several new risk markers of lower frequency or small effect size, and provide the best opportunity to date to identify gene variants associated with specific histologic subtypes and patient survival. OBJECTIVE As part of this GWAS expansion NCI will analyze DNA samples stored at the biobank of the Fox Chase Cancer Center (FCCC), a NCI-designated Comprehensive Cancer Center research facility and hospital, from approximately 1,891 RCC patients. SCOPE The Contractor shall: 1) Select approximately 1,891 RCC cases with banked germline DNA or blood samples; 2) Extract DNA for those subjects without previously extracted DNA; 3) Aliquot and ship DNA specimens from 1,891 FCCC patients to NCI; and 4) Provide data for the subjects and assist in answering and resolving study-related questions. The data shall include selected demographic characteristics (age at diagnosis, age at specimen collection, sex, race) and any available risk factors (family history of kidney cancer, smoking status, height, weight, history of hypertension) and clinical data (stage, grade, tumor size, bilaterality, histology, date of death, cause of death, date of first recurrence). CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS The Contractor shall perform the following tasks. 4.1 Select approximately 1,891 RCC cases (ICD-9 / ICDO-1 89.0; ICD-10 / ICDO-2 C64) with banked germline DNA or blood from its biobank. 4.2 Extract DNA from subjects for whom DNA is not already available and quantify by PicoGreen or similar technique. 4.3 The Contractor shall aliquot samples of native genomic DNA from each case. The aliquoted samples shall contain 2 micrograms of DNA, at a concentration of 50-80 ng/ul and a minimum volume of 25ul 4.4 The specimens shall be placed in Sarstedt 1.5mL screw top cryovials (PN 72.703.406) or similar tube labeled with printed human-readable ID and, if possible, a corresponding 1D or 2D barcode. The cryovials containing the specimens shall be shipped in clearly labeled freezer boxes. 4.5 The specimens shall be shipped on dry ice to the NCI Staging Laboratory. The shipment of specimens shall occur on either a Monday, Tuesday or Wednesday only via same day or overnight delivery. All specimens shall be shipped at the same time. 4.6 A specimen manifest shall be provided for the samples prior to shipment. 4.7 Provide data for the subjects and assist in answering and resolving study-related questions. The data shall include selected demographic characteristics (age at diagnosis, age at specimen collection, sex, race) and any available risk factors (family history of kidney cancer, smoking status, height, weight, history of hypertension) and clinical data (stage, grade, tumor size, bilaterality, histology, date of death, cause of death, date of first recurrence). PLACE OF PERFORMANCE The work shall be performed at the Contractor's Facility. REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE The NCI Technical Point of Contact will review the contents and quality of the specimens sent. The Technical Point of Contact will review the specimen manifest and covariate data provided. The Technical Point of Contact will be provided at the time of award. If no comments or requests for revisions are provided within 30 days, the deliverables shall be considered acceptable. DELIVERABLE DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS DUE DATE #1 (Task 4.5) The specimens shall be placed in Sarstedt 1.5mL screw top cryovials (PN 72.703.406) or similar tube labeled with printed human-readable ID and, if possible, a corresponding 1D or 2D barcode. Specimens shall be shipped on dry ice to the NCI Staging Laboratory. The shipment of specimens shall occur on either a Monday, Tuesday or Wednesday only via same day or overnight delivery. All specimens shall be shipped at the same time. July 31, 2019 or one year after date of award, whichever is later #2 (Task 4.6) The Contractor shall deliver a summary report of the samples aliquoted and shipped at the time of shipment. July 31, 2019 or one year after date of award, whichever is later #3 (Task 4.7) The Contractor shall provide data for the subjects and assist in answering and resolving study-related questions. The data shall include selected demographic characteristics (age at diagnosis, age at specimen collection, sex, race) and any available risk factors (family history of kidney cancer, smoking status, height, weight, history of hypertension) and clinical data (stage, grade, tumor size, bilaterality, histology, date of death, cause of death, date of first recurrence). July 31, 2019 or one year after date of award, whichever is later No other known institution manages specimens from FCCC biobank. Given the large number of RCC patients' samples available from FCCC and the detailed clinical information available from these patients, obtaining samples from this institution is critical to the success of the GWAS by ensuring reasonable statistical power to identify risk variants that are harder (i.e., weaker effect size, rarer frequency) and enabling analyses of patient survival. Few institutions or studies have both this large number of banked RCC germline DNA samples and clinical data, making FCCC an essential contributor to the project. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 5:00 PM EST, on July 30, 2018. All responses and questions can be emailed to Kimesha Leake, Contracting Officer via electronic mail at kimesha.leake@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 in the System for Award Management (SAM) through sam.gov. Reference: N02CP82593-24 on all correspondence.
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