Q -- GENOTYPIC AND PHENOTYPIC TESTING/ANALYSIS ON ANTIRETROVIRAL DRUG RESISTANCE FOR SELECTED HIV-1 STRAINS

Notice Date

March 26, 2001

Contracting Office

Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, GA, 30341-4146

ZIP Code

30341-4146

Solicitation Number

2001-Q-00074

Response Due

April 10, 2001

Point of Contact

Sherry Smallwood, Contract Specialist, Phone (770)488-2641, Fax (770)488-2671, Email SSmallwood@CDC.GOV

E-Mail Address

Sherry Smallwood (SSmallwood@CDC.GOV)

Description

The Centers for Disease Control and Prevention (CDC) has a requirement to obtain genotypic and phenotypic testing/analysis of HIV-1 strains in specimens obtained from six clinical research sites in the United States currently conducting a VAX004 AIDSVAX study. This is a combined synopsis/solicitation using simplified acquisition procedures. This announcement constitutes the only solicitation. Quotes are hereby requested, and a written solicitation will not be issued. Solicitation No. 2001-Q-00074 is hereby issued as a Request for Quotation (RFQ). The associated NAICS code is 541380 and the small business size standard is $5 million. BACKGROUND AND NEED: Hypothesis -- Resistant HIV-1 virus is being transmitted and is detectable in a growing proportion of antiretroviral drug-naive patients. Within the United States, the introduction of new antiretroviral drugs and drug combinations has increased their availability and use. Because of drug selection pressures together with the natural mutational attributes of HIV-1, resistant strains and their transmission may be increasing. To address this, epidemiologic surveillance for antiretroviral drug resistance among isolates of HIV-1 from drug-naive recently infected individuals can provide information of benefit to public health. It will determine if there is transmission of resistant viral genotypes and phenotypes from HIV-1 infected, presumably drug-experienced persons to uninfected persons, and it will determine the distribution of resistant viral genotypes and phenotypes among persons who are drug-naive. Surveillance can potentially benefit communities or geographic areas by providing information that might impact recommendations for resistance testing and treatment. PROJECT OBJECTIVES: To perform genotypic and phenotypic analysis of HIV-1 strains to determine the distribution of resistant strains among drug naive individuals. GENERAL REQUIREMENTS: The contractor shall provide the mechanism for laboratory studies on antiretroviral drug resistance for selected HIV-1 strains obtained from six clinical research sites in the United States currently conducting the VAX004 AIDSVAX study. Two methods shall be used by the contractor. The first, genotypic characterization, shall be performed on all specimens and involves direct genetic sequencing of the polymerase-protease area of HIV-1. The second, phenotypic characterization, shall be used on a subset of specimens, based on genotypic findings, and is the biological determination, through recombinant and cellular methods of antiretroviral drug susceptibility. SPECIFIC REQUIREMENTS: The contractor shall provide all labor, technology, materials, drugs, supplies, equipment, transportation, and other incidentals necessary to conduct genotypic and phenotypic analyses of HIV-1 drug resistance of specimens representing selected HIV-1 strains from a multi-site study. In addition, the contractor will cover transportation costs (COD) for specimens to be shipped to their facility for analysis. Task 1. Perform genotypic analysis on all plasma specimens. The contractor shall amplify by PCR methods and perform sequencing analysis of all of the protease region and, approximately, the first 305 amino acids of the reverse transcriptase region. The contractor shall report all mutations that differ from the consensus sequence. The analysis shall report the mutations for the dominant species, as well as for minor species, when detected. The raw sequence data (the chromatographic data as well as the ASCII text sequence file) shall be stored in an electronic format. to be delivered to the Project Officer and his designee at the completion of the entire study. The contractor shall submit to the Project Officer all genotypic data by hard copy and by disk or electronic transfer at the conclusion of all genotypic testing. A hard copy shall be delivered to designees of the Project Officer at the completion of testing of each specimen. Task 2. Perform phenotypic analysis on a subset of specimens. The contractor shall use a recombinant method. The contractor shall use already amplified material to conduct phenotypic analysis on a subset of specimens, approximately 10-30% of the total number of specimens, based on genotypic findings as determined by the Project Officer. The contractor shall use all of the protease and the first 305 amino acids of the reverse transcriptase region, using the same amplified material as for the genotypic analysis. The antiretroviral drugs used in the assay shall be those currently approved by the FDA. Drugs that are not approved but are available through expanded access could be included in the panel as well. Phenotypic data shall be submitted to the Project Officer by hard copy and by disk or electronic transfer at the conclusion of all phenotypic testing. GOVERNMENT PROVIDED MATERIALS, WORK PROCEDURES, DELIVERIES: Within 30 days of the award date of the contract, plasma specimens in 0.5 ml aliquots will be shipped to the contractor for genotypic analysis. Specimens will be shipped to the contractor initially in one batch lot of 30-50 samples and then as individual specimens and one monthly batch of 1-4 specimens. The contractor will complete genotypic analysis of this first batch of 30-50 specimens within 45 days of receipt of the specimens as specified in F. below. Upon successful completion of the genotypic analyses required for this batch, the CDC will ship additional individual specimens over 24 months for genotypic analysis to be completed within 15 days of receipt of each specimen. The contractor will commence genotypic analysis of the specimens upon receipt of the specimens. The contractor shall maintain all specimen identification numbers as directed by CDC. The CDC will notify the contractor in writing to commence work on the phenotypic analyses within 10 business days of successful completion of all genotypic analyses. The contractor shall provide reports of phenotypic analyses within 45 days of being notified in writing to conduct them. Any excess plasma sample not used for purposes stated in the contract shall be returned to CDC Project Officer or his designee, as these specimens were collected for analysis under a CDC IRB-approved protocol, and any additional testing requires review by the CDC IRB to ensure consistency with the approved protocol. If CDC requests that the contractor return unused samples back to the CDC, then CDC will bear the costs of shipping these samples. DELIVERABLES/DELIVERY SCHEDULE: The period of performance is from the effective date of the contract through June 30, 2003. During this contract period, the contractor shall perform genotypic analysis for 50-125 specimens, and of this amount the contractor shall perform phenotypic analysis for 10- 40 specimens. The contractor shall provide to the Project Officer or his designees the following deliverables within the time frames specified: Genotypic Analysis a. The contractor shall provide hard copies of genotypic analysis reports with interpretation within 45 days of receipt of the original batched lot of 50-125 specimens and within 15 days of receipt of the monthly batched lots of 1-4 specimens and individual specimens to two designees of the Project Officer. b. The contractor shall provide hard copies of genotypic analysis reports with interpretation within 15 days of receipt of each individual specimen and monthly batched specimen to the designees of the Project Officer. c. The contractor shall provide genotypic analysis reports with interpretation and raw sequence data in an electronic format (by disk or electronic transfer) and by hard copy for all specimens tested within 45 days of the completion of the study to the Project Officer. Phenotypic Analysis a. The contractor shall perform phenotypic analyses results within 45 days of being notified in writing to conduct them. b. The contractor shall provide phenotypic analysis reports with interpretation and raw sequence data in an electronic format (by disk or electronic transfer) and by hard copy for all specimens tested within 45 days of the completion of the study to the Project Officer. AWARD SELECTION: Award will be made to the offeror whose integrated proposal (laboratory methods, organizational experience, personnel qualifications, past performance, and price) is determined by the Government to be the best overall value to the Government. PROPOSAL SUBMISSION: Proposals must be priced for the following CLINS: CLIN 0001, Perform genotypic analysis on all plasma specimens in accordance with the requirements of the statement of work, quantity = 125 maximum specimens; CLIN 0002, Perform phenotypic analysis on a subset of plasma specimens in accordance with the statement of work, quantity = 40 maximum specimens. In addition to a price proposal, all offerors must submit a work plan that (a) describes the offeror's laboratory methods for determining genotype and phenotype, (b) describes the offeror's organizational experience in performing similar work, (c) demonstrates that the offeror's personnel who will be performing this project have adequate training and experience in performing similar work, and (d) past performance references for the last 5 contracts the organization has received for work similar in size and complexity to this acquisition. Quotes are due at 2:00 PM EST on April 10, 2001 to the following address: Centers for Disease Control & Prevention, Procurement & Grants Office, ATTN: SHERRY SMALLWOOD, 2920 Brandywine Road, Atlanta, GA 30341-4164. Facsimile quotes may be faxed to (770) 488-2671. Quotes received after the time and date set for receipt of quotes will not be considered for award.

Web Link

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Record

Loren Data Corp. 20010328/QSOL003.HTM (D-085 SN50H394)