Combined_JA_JWC (Redacted).pdf

b. Project background.

Laboratory of Pathology (LP)

The Clinical Oncologic Molecular Pathology Sequencing Service (COMPASS) program in the Laboratory of Pathology at the National Cancer Institute is committed to advancing genomic research and offering genomic testing so that new treatments, therapies and therapeutics against cancer can be developed. The COMPASS program has implemented DNA methylation and NGS panels to identify genetic changes in clinical specimens from cancer patients who are being evaluated and/or treated by the Intramural program of the National Cancer Institute.

Overall, the COMPASS program performs testing to identify genetic and epigenetic alterations to assist in the diagnosis of a variety of cancers. The laboratory develops tests that assist in pathologic diagnosis, predict prognosis, and identify potential targets for rational personalized therapies. It is currently the only CLIA and College of American Pathology approved clinical laboratory within the NCI certified for performing molecular oncology testing on materials from NIH patients.

The lab extracts DNA and RNA from over 1500 FFPE tissue specimen, DNA from over 1000 blood, bone marrow or other liquid specimens. In current time, all these extractions are performed as manual or semi-automated process. With increasing test requests from NIH clinical center an automated DNA/RNA extraction system is needed. Additionally, a nucleic acids extraction instrument is needed to handle increasing number of requests for extraction from FFPE tissue.

Genitourinary Malignancies Branch (Banday Lab)

The Banday Lab, of the Genitourinary Malignancies Branch (GMB) currently has focused research efforts related to Bladder Cancer, which is the 10th most common neoplasm worldwide and for which treatment option remain limited.

The goal of the Banday Lab is to elucidate mechanisms and map therapeutically actionable pathways underlying genetic and molecular alterations in bladder cancer. Specifically, the lab uses functional genomics and bioinformatics approaches to explore molecular mechanisms that drive and support tumor progression, weaken or inhibit tumor-immune surveillance, and impart resistance to therapies. To accomplish this, research is focused on three areas:

Mechanisms underlying genetic alterations in bladder cancer Role of APOBEC3s in tumor evolution and interactions with cancer therapies Explore and exploit RNA splicing dependencies in tumors as druggable targets for cancer therapies

Laboratory of Cancer Biology and Genetics (LCBG)

The Laboratory of Cancer Biology and Genetics focuses on the study of several different types of cancer from the aspects of molecular biology, biochemistry, cell biology, genetics and biology. Many scientists from LCBG perform isolation of RNA and DNA routinely. LCBG currently utilizes a QIAcube system for RNA and DNA isolation; however, the inner chamber and centrifuge of the QIAcube have shown the sign of wear and tear and is near the end of its useful life cycle. This machine has been used by scientists from up to 10 laboratories in LCBG. Given the number of users, and validated protocols the lab requires a new machine that will reduce, or eliminate the need for revalidation, as well as ensure scientific comparability with previous research efforts.

3. Description of the supplies required to meet the agency’s needs (including the estimated value).

a. Project title. Procurement of Three (3) Brand Name Qigen QIAcube Connect MDx FUL-1, Associated Accessories, and Supplies.

b. Project description.

The QIAcube Connect MDx is designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications using QIAGEN spin-column technology. Thereby, it combines the outstanding performance in standardization of sample processing from lysis to purification. Spin column kits and sample information can be easily imported by scanning the kit barcode using the barcode reader. The system has a capacity for full worktable decontamination for maximum user and sample safety. Monitoring the process and instrument status from remote is possible with the new QIAsphere app.

1. Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D)

X Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

2. Type of action.

X New requirement Follow-on Other (specify): ______________________

3. Proposed contract/order type.

X Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

4. Acquisition identification number.

Solicitation and Award number are to be determined.

c. Total estimated dollar value and performance/delivery period.

Estimated delivery, installation, and training is twenty-one (21) days after receipt and acknowledgement of award.

4. Identification of the statutory authority permitting other than full and open competition.

X This acquisition is conducted under FAR 13.106-1 (b)(1)(i)

(b) Soliciting from a single source.

(1) For purchases not exceeding the simplified acquisition threshold.

(i) Contracting officers may solicit from one source if the Contracting Officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the Brand Name contractor(s).

QIAGEN - Sample & Assay Technologies 19300 Germantown Road Germantown, MD 20874 Cell: 240-449-5109 Fax: 661-702-3904 jeffrey.durocher@qiagen.com www.qiagen.com

Government Scientific Sources 12351 Sunrise Valley Drive Reston, VA 20191 Phone: 1-800-248-8030 govsci.com

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

Qiagen QIAcube Connect MDx is compatible with Qiagen consumable kits currently possessed by all three (3) laboratories which are utilized for RNA/DNA extraction and isolation in support of their various research efforts. In addition to the need for compatibility with currently utilized consumable kits, two (2) of the three (3) labs have established validated protocols utilizing the Qiacube system platform for both clinical and non-clinical research. As such, the QIAcube Connect MDx is the only system that can reduce or eliminate the need for revalidation of lab protocols, as well as ensure scientific comparability between new and previous patient care and research efforts already conducted utilizing QIAcube system platforms.

Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

This requirement is exempt from FAR 5.2, per the exception contained under FAR 5.202 (a)(13). The requirement will be posted to SAM.gov utilizing a combined synopsis/solicitation per FAR Part 12, utilizing the authority for simplified acquisitions contained under FAR Part 13. Per FAR 13.105 (c), this justification will be published with the solicitation.

Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The Independent Government Estimate (IGE) was developed based on IGEs provided with each laboratory’s initial procurement request. The Contracting Officer will consider the IGE, past contract pricing for similar procurements, competitive quotations, or any other reasonable basis allowed per FAR 13.106-3 (a)(2).

Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Market research was completed conducted utilizing Required Sources, Federal Supply Schedules, NIH Strategic Sources, Commercial Websites, historical data, and correspondence with industry. The Contracting Officer has determined that the required instrument is commercially available via the open market from two (2) businesses.

9. Any other facts supporting the use of other than full and open competition.

All facts have been previously stated.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources have expressed written interest in the proposed acquisition. All sources who respond to the combined synopsis solicitation will be considered.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

NCI anticipates the need to be successfully met. If upon completion of the anticipated Purchase Order it is identified that similar or additional equipment are needed, the NCI will conduct market research to re-evaluate if there are other manufacturers and products that can meet the salient characteristics required by NCI.