MODIFICATION
Q -- Germline mutation testing and variant validation in inherited bone marrow failure syndromes
- Notice Date
- 9/8/2015
- Notice Type
- Modification/Amendment
- NAICS
- 621511
— Medical 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
- NCI-N02CP52565-85
- Archive Date
- 9/24/2015
- Point of Contact
- Chad M. Shearer, Phone: 2402766801
- E-Mail Address
-
chad.shearer@nih.gov
(chad.shearer@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- ****Response Date Updated to Reflect September 9th, 2015**** Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Dr., Room 1E638, Rockville, MD 20850. Description The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Clinical Genetics Branch (CGB) plans to procure services including the validation of genetic variants that are identified through CGB's gene, exome, and whole genome sequencing research order to appropriately classify family members as affected or unaffected with disease. Additionally, testing of germline mutation will be ordered within this study as the need arises. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1(b)(2) and 13.501-(a)(1) using simplified acquisition procedures for commercial acquisitions. The North American Industry Classification System code is 621511 and the business size standard is $32.5 million. Only one award will be made as a result of the solicitation. This will be awarded as an Indefinite Delivery, Indefinite Quantity where firm fixed price task orders will be issued. This will be awarded using Full and Open Competition. Period of Performance shall be from award through sixty (60) months. It has been determined there are no opportunities to acquire green products or services for this procurement. The CGB is conducting this project as part of a comprehensive, multidisciplinary, intramural research program within DCEG's Human Genetics Program, which is focused upon elucidation of the entire spectrum of scientific and clinical issues related to hereditary forms of cancer. This is an ongoing study. The contractor shall perform the following tasks: CLIA-certified germline genetic testing, including sequencing, insertion/deletion analyses, and testing for large rearrangements, to identify clinically relevant variants. Additionally, the contractor shall also perform CLIA-certified validation of variants that are identified by CGB investigators during research-level gene, whole exome, and/or whole genome sequencing. All sequencing and variant validation must be performed within a CLIA lab. Sequencing: When the contractor detects a mutation in a gene, 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 (5' and 3' strands). For mutation-specific testing, bi-directional sequence analysis of only the amplicon containing the specific mutation will be carried out. Additional Testing Information: The NCI requires validation of variants in genes discovered in research studies. One Task Order will be a request for variant validation. The attached list of genes (Attachment I) is intended to demonstrate the types of single genes that may need to be requested for an individual patient. There is no intention to ask for sequencing of all the genes on the list for any patient at one time. Proposal prices should reflect estimated cost for individual tests that may be requested, one test per task order, such as: RPS 17 test, RPS 19 test, FANCA, TERC, etc. It is understood by NCI that different tests have different costs. It is our intent for the proposal to estimate what the average cost of a test might be, considering both the least and most costly from the list of genes provided, so that the minimum and maximum cost of the contract can be determined. This estimated cost will not be binding for all tests, but will allow us to determine the approximate ceiling of the contract based on the number of tests needed over the course of the period of performance. For result reports, the contractor shall provide detailed results 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. The contractor shall deliver result reports to NCI within 4-8 weeks of sample receipt. Potential offerors may request a copy of the solicitation from Chad Shearer, Contract Specialist via electronic mail at chad.shearer@nih.gov. Interested parties shall include the name of company; complete mailing address; point of contacts, phone, fax numbers, and email address; company DUNS number and business size. In addition, the responses must be received by 3:30 PM EST on September 9, 2015. Deadline for questions is September 1, 2015. 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 Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) which are both completed at www.sam.gov. Reference: RFQ-NCI- N02CP52565-85 on all correspondence. ATTACHMENT I - Required Genes List FANCA FANCB FANCC FANCD BRCA2 FANCD2 FANCE FANCF FANCG XRCC9 FANCI FANCJ BACH1 BRIP1 FANCL FANCM FANCN PALB2 DKC1 TINF2 TERC TERT NOP10 NOLA3 NHP2 NOLA2 RPS19 RPS24 RPS17 RPL5 RPL11 RPL35A SBDS ELA-2 ELANE
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/NCI-N02CP52565-85/listing.html)
- Place of Performance
- Address: 9609 Medical Center Drive, Rockville, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03876052-W 20150910/150908235933-036ac24f214bc6415594f0d6f9ec0f87 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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