Short Title: Tissue sample and data preparation for Sherlock-Lung study among never-smoking adenocarcinoma cases in Hong Kong, China
Document Type: Notice of Intent
Solicitation Number: 75N91019R00037
Posted Date: 8/6/2019
Response Date: 8/16/2019
Classification Code: B - Special Studies and Analyses - Not R&D
NAICS Code: 541990 - All Other Professional, Scientific and Technical Services

Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E232 Bethesda, MD 20892, UNITED STATES

Description

The NCI is conducting whole-genome sequencing study of lung adenocarcinoma tumors from never-smokers in Asia to identify exposure-related mutational signatures to extend its findings and will compare results with signatures identified in cases it is analyzing from other parts of China, Asia, the West, and other regions as part of the Sherlock-Lung study. Hong Kong has been selected as one of the study sites for this project.

To achieve the goal of Sherlock-Lung study, it's critical to collect fresh-frozen tumor and normal tissues, FFPE tumor tissue, FFPE normal lung tissue, blood samples and data from never-smoking female and male lung cancer cases. The contractor shall obtain samples from frozen fresh tumor tissue and adjacent normal lung tissue, FFPE tumor and normal lung tissue, matched blood sample, accompanying H and E diagnostic slide and copy of CT report.

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)(1) using simplified acquisition procedures for commercial items. The North American Industry Classification System code is 541990 and the business size standard is $15,000,000.

Only one award will be made as a result of this solicitation. This will be awarded as a non-severable firm fixed price type contract.

It has been determined there are no opportunities to acquire green products or services for this procurement.

The Contractor shall perform the following tasks for 200 never-smoking female and male lung cancer adenocarcinoma cases with fresh-frozen tumor tissue and adjacent normal tissue samples from these 200 cases enrolled in Hong Kong:

1.1 Evaluate the tumor tissue by H and E staining method to determine an estimate of the percentage of tumor cells.
1.2 Cut fresh-frozen tumor tissue with at least 50% tumor from each lung cancer case and store in 1.8ml sterile cryovials.
1.3 Cut fresh-frozen normal lung tissue from each lung cancer case and store it in 1.8ml sterile cryovials
1.4 Prepare for each lung cancer cases at least 8 sections of 10 µm from FFPE tumor tissue.
1.5 Prepare for each lung cancer cases at least 8 sections of 10 µm from FFPE normal lung tissue.
1.6 If there are blood samples available, prepare an aliquot of at least 1 ml of whole blood or a buffy coat sample derived from at least 1 ml of whole blood, or at least 2 ug of DNA derived from a buffy coat sample.
1.7 Send an H and E diagnostic slide for each case or a photomicrograph and a copy of the patient's CT report with any identifier removed if available.
1.8 Fresh-frozen tissues should be shipped on dry ice to the laboratory designated by NCI. FFPE tissues at room temperature and H&E diagnostic slides should be shipped at room temperature.
1.9 Fill out a study subject log in Excel file format that will be provided by NCI that will include date of diagnosis, type of procedure used to obtain the sample, age and sex of study subject by the end of the period of performance.
1.10 Shipping charges must be included in the quote. NCI will not be responsible in the event
charges are not included in the quote.

Note: NCI plans to award a contract that has FOB origin delivery terms.

The period of performance shall be for 12 months from September 15, 2019 to September 14, 2020.

University of Hong Kong has exceptional experience in genetic research. Moreover, it has carried out and published molecular epidemiology studies and has a well-conducted molecular pathology study of lung cancer in Hong Kong. Queen Mary Hospital at the University of Hong Kong stores fresh tumor tissues, blood samples collected from lung cancer cases in Hong Kong and is the only hospital in Hong Kong or anywhere else in the world that stores frozen tissues on large numbers of lung cancer cases from Hong Kong. The university is well-qualified concerning all aspects required for the completion of this contract and has unique staff and experience that is necessary to carry out the terms of this procurement. Further, NCI has conducted a genome-wide association study (GWAS) of lung cancer cases from non-smoking females on tissue samples provided by the University of Hong Kong, and it is important that the data can be linked to whole-genome sequencing data that will be obtained from this procurement.

The University of Hong Kong has previously successfully provided tumor tissue samples from cases for NCI lung cancer studies (HHSN261201600748P). Given that using the same case identification procedure, pathology review for lung cancer cell enrichment, sample collection and storage protocol as well as validation and selection of optimum samples for the NCI in the previous and current studies in Hong Kong, it is necessary that there be scientific comparability between the results of that study and the results of this one so as to maintain consistency by combining the two study results to increase study power. Thus, the proposed vendor is the sole source to perform the required analyses.

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 12:00 PM EST, on August 16, 2019. All responses and questions must be in writing and faxed 240-276-5401 or emailed to David Romley, Contract Specialist OR via electronic mail at [email protected]. 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. No collect calls will be accepted. 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: 75N91019R00037 on all correspondence.