SOLICITATION NOTICE
Q -- Biomarker Testing
- Notice Date
- 1/19/2017
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6710B Rockledge Dr., Suite 1124, MSC7000, Bethesda, Maryland, 20892-7510, United States
- ZIP Code
- 20892-7510
- Solicitation Number
- NICHD-17-046
- Archive Date
- 2/9/2017
- Point of Contact
- Tina Robinson, Phone: 301-443-7796
- E-Mail Address
-
tr207f@nih.gov
(tr207f@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation number is NICHD-17-046 and is issued as a Request for Quotation (RFQ). The solicitation/contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2005-95. The North American Industry Classification (NAICS) Code is 541380 and the business size standard is $15m. However, this solicitation is not set aside for small business. This acquisition is being conducted using Simplified Acquisition Procedures in accordance with FAR Part 13. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) intends to contract on a sole source basis with Myriad RBM - 3300 Duval Road - Austin, TX 78759 to provide biomarker testing of patients samples and provide the following multiplexed assays that include biomarkers that will be used to monitor potential therapeutic efficacy of vorinostat in treating Niemann -Pick C1 patients: 1. Human ExplorerMap v.1.0 (serum /Plasma) - 400µL sample requirement - Fatty Acid-Binding Protein, adipocyte Galectin-3 Receptor tyrosine-protein kinase erbB-3, Quantity 50 EA 2. Human CustomMap HMPC68 - Thyroglobulin Tissue type Plasminogen activator, Tyrosine Kinase w/Ig and EGF homology domains 2, Urokinase-type Plasminogen Activator, MHC Class I chain-related protein A - Quantity 50 EA Myriad will provide their standard result report and sample disposition return and samples after testing services. Sole sourcing to Myriad because of the following: • The testing to be done by is in support of a phase 1/2a trial protocols that were performed by Myriad RBM. All of these protocols involve Niemann-Pick disease, type C1 patients and prior testing included control pediatric samples. Use of Myriad would provide consistent testing across studies and avoid having to obtain repeat testing of samples to establish consistency. • Myriad RBM has done prior testing for a protocol which included pediatric control CSF samples. Use of another company would require redoing a control set. It would be prohibitively expensive to repeat these pediatric controls, the availability of control pediatric CSF is extremely limited. The NICHD would have to recollect many control samples prior to being able to proceed. Prior testing included patients that enrolled in this therapeutic trial. Thus use of alternative company would not allow us to compare with longitudinal data collected under our Natural History protocol. This would be a major limitation that would require repeating the prior assays with a new company. Again this would be duplication of expense and would utilize a limited resource. • Because this data may ultimately be used to support a therapeutic intervention for Niemann-Pick disease type C1 and a new drug application, it must be done under strict laboratory conditions. These include Clinical Laboratory Improvement Amendments and Commission on Office Laboratory Accreditation certification and participation in College of American Pathologist internal proficiency testing. • For experimental and regulatory validity rigorous quality control must be applied. Specifically, Levey-Jennings charts and Westgard rules to measure assay performance longitudinally for assay acceptance criteria. • To increase precision robotic liquid handlers should be utilized and to avoid sample errors all sample data should be tracked and maintained within an automated laboratory information management system. With regards to the specific analytes, this testing will give us information on 150 analytes from 400 microliters of serum. Obtaining the necessary information from a minimal volume of serum is critical in order to maximize the information that can be obtained from the available specimens that have to be collected from protocol patients. Based on our prior work, two analytes must be included in the panel. These primary analytes include galectin-3 and cathespin D. Secondary analytes include MIP-1α, cytokines (IL-1α, IL-1β, IL-6, IL-8, and TNFα) and markers of innate immunity (ferritin, C3, C-reactive protein, haptoglobin). As outlined above, use of another company would be both expensive due to the need to repeat testing and would waste valuable samples. The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under authority of the 41 U.S.C. 253(c) (1), FAR 6.302. The offeror must include a completed copy of the provision of FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Items with its offer. The provisions of FAR Clause 52.212-1 Instructions to Offerors - Commercial Items; FAR Clause 52.212-2, Evaluation - Commercial Items; FAR Clause 52.212-4, Contract Terms and Conditions - Commercial Items; and FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items - Deviation for Simplified Acquisitions applies to this acquisition. The offeror must include their Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. The clauses are available in full text at http://www.acquisition.gov/far/. Interested vendors capable of furnishing the government with the services/products specified in this synopsis should submit a copy of their quotation to the following email address robinsti@mail.nih.gov. Offers must also be accompanied by descriptive literature, delivery/turnaround timeframe, warranties and other information that demonstrates that the offer meets all of the foregoing requirements. Quotations will be due fifteen calendar days from the publication date of this synopsis or by February 2, 2017 by 10:00am EST. via email to robinsti@mail.nih.gov. The quotation must reference "Solicitation number" NICHD-17-046. Any questions must be sent via email to robinsti@mail.nih.gov and must include solicitation# NICHD-17-046 in the subject line of email. Faxed copies/responses will not be accepted. Note: In order to receive an award, contractor must be registered and have valid certification in the SAM database @www.sam.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NICHD-17-046/listing.html)
- Place of Performance
- Address: Myriad, Austin, Texas, 78759, United States
- Zip Code: 78759
- Zip Code: 78759
- Record
- SN04375950-W 20170121/170119234738-a48213568391ea495f37550a5c1f4619 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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