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FBO DAILY ISSUE OF JULY 10, 2009 FBO #2783
MODIFICATION

B -- Nanoscale Multiplex Real-Time PCR Detection of Pathogens in Blood

Notice Date

7/8/2009
 

Notice Type

Modification/Amendment
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

FDA-09-1056047
 

Archive Date

8/4/2009
 

Point of Contact

Tara R. Hobson, Phone: 3018279691, Doreen Williams , Phone: 301-827-3366
 

E-Mail Address

Tara.Hobson@fda.hhs.gov, doreen.williams@fda.hhs.gov
(Tara.Hobson@fda.hhs.gov, doreen.williams@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

RESPONSE DATE HAS BEEN EXTENDED TO JULY 20, 2009 AT 4:30PM EST. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, streamlined procedures for evaluation and solicitation for commercial items-as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. This solicitation is being issued using simplified acquisition procedures 13.5. This solicitation is a Request for Quotations (RFQ). The solicitation document and incorporation provisions and clauses are those in effect through Federal Acquisition Circular 05-32. This announcement constitutes the only solicitation and a written solicitation will be not issued. The associated North American Classification System (NAICS) code for this procurement is 621511. This procurement will be full and open competition. The purpose of this contract is to develop and test a platform that can perform real-time PCR on a nucleic acid sample extracted from blood testing for the presence of 10 or more pathogens simultaneously in a volume less than 25ul. The platform must be optimized to achieve the greatest degree of sensitivity possible while achieving the highest possible level of multiplicity. This will be a labor hour contract for one year. Background: Nucleic acid detection of pathogens in blood products to increase the safety of transfusion has proven to be the most sensitive and efficient method. However, with the number of pathogens recommended by the FDA for testing and the constant threat of newly emerging pathogens, the number of individual tests performed on each product unit is becoming burdensome and delays the process of fresh blood products reaching the patients in urgent need. To solve this problem, multiplex Nucleic Acid Tests (NATs) have been developed. To date the highest number of pathogens that can be assayed in one multiplex test licensed for blood screening is three, HIV, HCV and HBV. New technology must be developed that can achieve higher levels of multiplicity. Scope of Work: NAT assays targeted to specific blood borne pathogens are comprised of oligonucleotide primer pairs and a set of reaction conditions that have been optimized to give the most efficient amplification of the target. Such NAT assays have been developed by scientists in the Division of Emerging and Transfusion Transmitted Diseases for at least ten different blood borne pathogens individually. The contractor will take these primer pairs and associated reaction conditions and combine them into a Nanoscale Multiplex platform that can perform real-time PCR with at least 10 reactions simultaneously. The platform will also incorporate internal standards to provide quantitative and QA/QC for each test. The FDA investigators will provide nucleic acid samples extracted from the various pathogens as well as nucleic acid extracted from blood samples that have been spiked with pathogens. The contractor will use these samples to evaluate and optimize the performance of the Nanoscale Multiplex platform. The contractor will report the data on limits of detection of each pathogen when assayed on the Nanoscale Multiplex platform. The Contractor will perform these tasks: Task 1.0Meet with the project officer and develop study design. Subtask 1.1The Contractor shall meet with the Government Project Officer (PO) within two weeks after the date of award to discuss the study design and requirements. The study design described in the proposal will be reviewed at this meeting. Subtask 1.2The contractor shall prepare and submit a summary report of the meeting not later than seven (7) days after the meeting. Task 2.0Receive blood pathogen oligonucleotide primers and reaction conditions for individual pathogen detection NAT assays Subtask 2.1Accept delivery of blood pathogen primers, notify sender of receipt, store properly Task 3.0Assemble Nanoscale Multiplex PCR processing devices with blood pathogen primer sets Subtask 3.1Load individual primer pairs into nanoscale reaction chambers in multi-chamber array Subtask 3.2Store arrays for subsequent sample processing Task 4.0Receive and store nucleic acid samples from cultured pathogens Task 5.0Optimize detection with pathogen nucleic acid Subtask 5.1Demonstrate detection is possible Subtask 5.2Determine lower limit of analytical sensitivity for pathogen nucleic acid Task 6.0Report results to Project Officer or his designee and plan subsequent experiments Task 7.0Optimize detection with nucleic acid from pathogen spiked blood Subtask 7.1Receive and store nucleic acid samples from pathogen-spiked blood samples Subtask 7.2Demonstrate detection is possible Subtask 7.3Report interim results to Project Officer or his designee (telephone and email is sufficient) Subtask 7.3Determine lower limit of sensitivity for pathogen spiked blood sample nucleic acid Task 8.0Finalize results Subtask 8.1Prepare results in publication-ready format Subtask 8.2Communicate results to Project Officer or his designee Delivery Schedule: Item DescriptionDue Date after award 1Meet with project officer2 weeks 1.1Summary report of meeting3 weeks 2Accept delivery of blood pathogen primers, notify sender of receipt, store properly1 month 3Assemble Nanoscale Multiplex PCR processing devices with blood pathogen primer sets3 months 4Receive and store nucleic acid samples from cultured pathogens3 months 5Optimize detection with pathogen nucleic acid6 months 6Meet with project officer or representative to evaluate the initial results and set agreed upon target pathogens for validation in Nanoscale Multiplex assay7 months 7Interim report to Project Officer on progress9 months 8Optimize detection with nucleic acid from pathogen spiked blood11 months 9Submit final report to project officer with publication-ready data validating the limit of detection of the agreed upon pathogens assayed in Nanoscale Multiplex format on the platform12 months Evaluation Factors: 1 Qualifications. The Offeror shall provide qualifications necessary to perform the 3multiplex real-time PCR detection of pathogens. This contract will involve complex interplay of multiple individual assays. Therefore, qualifications shall be demonstrated in testing, adjusting and optimizing new procedures in collaboration with the CBER scientists. 2. Technical Approach. The proposal shall demonstrate whether the Offeror recognizes the scope of the services required and can successfully accomplish these requirements with minimum risk to the Government. The offeror shall describe an Understanding of the Requirements in the scope of work. Also the offeror shall demonstrate their Work Approach/Methodology. 3. Past Performance. (1) The offeror shall provide relevant past performance on contracts, including peer reviewed publications if possible. The information provided will be screened to make the determination of its relevance to the current requirement. The Government is not bound by the offeror’s opinion of relevancy and will perform an independent assessment of the relevancy of contracts or subcontracts provided. It is ultimately the decision of the government to determine the relevancy and degree of relevancy to this acquisition. (2) Recent is defined as those contracts currently being performed and/or completed within the last (3) three years. (3) A relevant contract is defined as that of the same or similar scope, size, and complexity in performing work of the same nature as that of the requirement. The same nature is defined as providing the same type of work as required to be provided by the PWS. A neutral rating will apply when the offeror has little/no relevant past performance upon which to base a meaningful performance risk prediction. (4) Offerors shall include written consent of all teaming partners and subcontractors to allow the government to discuss the partner’s/subcontractor’s past performance information with the offeror. 4. Price. Please provide firm fixed price for one year. Award will be made to the party whose quote offers the best value to the Government, technical, price and other factors considered. The Government may award this contract other than lowest price technically acceptable quote. The Government will evaluate information based on the following criteria: 1) Qualifications 2) Technical Approach 3) Past Performance and 4) Price. Qualifications, Technically Approach and Past Performance are more important than price. The Period of Performance of this contract is for one year. QUESTIONS DEADLINE: All questions must be received by email (Tara.Hobson@fda.hhs.gov) before 4:30pm EST on July 1, 2009. Telephone calls will not be accepted. QUOTATIONS DUE: All quotations are due, via email to: Tara.Hobson@fda.hhs.gov, no later than 4:30pm EST on July 13, 2009. Vendors must be registered in the Central Contractor Register (CCR) prior to the award of the contract. You may register by going to www.ccr.gov. PROVISIONS AND CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. Offerors shall include a completed copy of FAR 52.212-3, Offeors Representations and Certifications-Commercial Items. The clause 52.212-4 Contract Terms and Conditions-Commercial Items applies to this acquisition. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items applies to the acquisition as well as the following clauses within: FAR 52.222-26, FAR 222-35, FAR 52.222-36, FAR 52.232-33, FAR 52.246-4 and FAR 52.246-6. Clauses and provisions are incorporated by reference and apply to this acquisition.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-09-1056047/listing.html)
 

Place of Performance

Address: FDA, 8800 Rockville Pike, Bethesda, Maryland, 20892, United States

Zip Code: 20892
 

Record

SN01868442-W 20090710/090708235759-8ad3574105d814e78901d0ff4b10d872 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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