Sequence-based detection of Minimal Residual Disease (MRD) in Acute Lymphoblastic Leukemia Patients.

Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E224, Rockville, MD 20850, UNITED STATES. 1. Description The National Cancer Institute (NCI), Center for Cancer Research (CCR), Pediatric Oncology Branch (POB) plans to procure service for Sequence-based detection of Minimal Residual Disease (MRD) in Acute Lymphoblastic Leukemia Patients. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 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 includes all applicable provisions and clauses in effect through FAR FAC 2005-89 (August 2016) Simplified Procedures for Commercial items. The Government contemplates only one award of a Firm-Fixed Price contract. The Associated North America Industry Classification Code (NAICS) 621511 and the Business Size Standard is $32.5M. It has been determined there are no opportunities to acquire green products or services for this procurement. Only one award will be made as a result of this solicitation. This will be 100% small business set-aside. 2. Background The Pediatric Oncology Branch (POB) is dedicated to improving outcomes for children and young adults with cancer and genetic tumor predisposition syndromes. NCI conducts translational research that spans basic science to clinical trials. NCI clinical studies are performed in an environment that supports NCI patient's medical and emotional needs, alongside cutting edge scientific research. The POB is in need of an assay more sensitive than flow cytometry to detect MRD in patient samples. These assays may improve the ability to define which patients may not require additional consolidative therapy such as hematopoietic stem cell transplantation after CAR treatment. The contractor needs to be able to perform highly sensitive sequence-based detection of Minimal Residual Disease (MRD) in CD22 CAR-treated patients participating in current, active POB protocols. The specific aim of this requirement is to allow a higher sensitivity than is currently available to POB investigators via flow cytometry. Minimal residual disease (MRD) is the name given to small numbers of leukemic cells (cancer cells from the bone marrow) that remain in the patient during treatment, or after treatment when the patient is in remission (no symptoms or signs of disease). Previously, none of the tests used to assess or detect cancer were sensitive enough to detect residual leukemia to the level of MRD. Flow cytometric evaluation allowed from MRD detection to the level of approximately 1 leukemic cell in 10,000 to 100,000 cells and was found to be an important predictor of relapse. Recently, very sensitive molecular biology tests have become available, based on DNA, RNA or proteins. In particular, targeted sequencing of rearranged immunoglobulin and T cell receptor loci can be used as a very leukemia specific market. These approaches can measure minute levels of cancer cells in tissue samples, sometimes as low as one cancer cell in a million normal cells. In cancer treatment, particularly leukemia, MRD testing now plays an important role in defining standard treatment. Data demonstrating the predictive power of MRD monitoring using flow cytometry in leukemia is robust and is being used to risk-stratify patients early in treatment, early detection of relapse, and determines the response level to novel therapeutics. MRD testing is often part of clinical research or trials, and some techniques have been accepted for routine clinical use. The POB currently has the ability to test for the presence of MRD in patients within 28 days after CAR therapy via flow cytometry. A detection method more sensitive than flow cytometry may improve the ability to define which patients may not require additional consolidative therapy such as hematopoietic stem cell transplantation after CAR treatment. 3. Contractor Tasks The contractor shall: 1. Extract DNA from patient samples provided by the POB at two-four different time points, pre-cancer treatment and 28 days post treatment; with possible additional samples sent at two months and three months after CAR therapy. 2. Survey sequencing of baseline samples at immunoglobulin and T cell receptor locus for specific DNA rearrangement established in baseline sample that is unique to leukemia. Deep sequencing of the informative locus at 28 days after treatment and, possibly at later timepoints depending on whether remission status defined by flow cytometry is sustained. 3. If detected, quantify the amount of MRD present in the patient sample. Measurements must be reproducible. 4. Targeted sequencing of the heavy chain of the B Cell receptor 5. Targeted sequencing of the gamma chain of the T Cell receptor 4. Deliverables The contractor shall provide a report summarizing the results within 10 days after processing the samples from the Government. The Contractor that receives the award will be provided with the complete mailing address and point of contact. Upon delivery, contractor must notify the NCI Contracting Officer's Representative (COR) to schedule the delivery date and time. 5. Period of Performance The Period of Performance shall be as follows: September 12, 2016 - September 11, 2017: Base Period September 12, 2017 - September 11, 2018: Option Period 1 September 12, 2018 - September 11, 2019: Option Period 2 6. Payment Payment shall be made after submission and approval of report stated in section 4. Payment authorization requires submission and approval of invoice to the NCI COR and NIH Commercial Accounts. 7. Contract Type Firm Fixed Price QUESTIONS ARE DUE: September 8, 2016 at 11:00 AM, EST. PROVISIONS AND CLAUSES: The following provisions and clauses will be incorporated by reference: 52.212-1 Instruction to Offerors Commercial Items (October 2015) 52.212-2, Evaluation Commercial Items (October 2014): The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: The order will be awarded to the Lowest Price Technically Acceptable (LPTA). The award will be made on the basis of the lowest evaluated price of quotations meeting or exceeding the requirements stated above. Offerors shall demonstrate knowledge and/or experience of each of the tasks listed above section 3. The technical evaluation will be a determination based on information furnished by the vendor. The Government is not responsible for locating or securing any information which is not identified in the proposal. The Government reserves the right to make an award without discussions. Offerors price proposal will be evaluated for reasonableness. For price to be considered to be reasonable, it must represent a price to the Government that a prudent person would pay when consideration is given to the price in the market. Normally, price reasonableness is established through adequate price competition, but may also be determined through price analysis techniques as described in FAR 15. 52.212-3 Offerors Representations and Certifications Commercial Items (April 2016) WITH DUNS NUMBER ADDENDUM (52.204-6) (July 2013): 52.212-4 Contract Terms and Conditions Commercial Items (May 2015), applies to this acquisition. (May 2015) 52.212-5 Contract terms and Conditions Required to Implement Statutes or Executive Orders---Commercial Items (June 2016). The following additional FAR clauses cited in this clause are applicable: (b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: 52.204-10 Reporting Executive Compensation and First Tier Subcontract Awards (Oct 2015) (Pub.L. 109-282) (31 U.S.C. 6101 note). 52.209-6, Protecting the Government' Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment October 2015) (31 U.S.C. 6101 note). 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a). 52.219-6 Notice of Total Small Business Set-Aside (NOV 2011) (15 U.S.C. 644) 52.219-28 Post Award Small Business Program Representation (JUL 2013) (15 U.S.C. 632(a) (2)). 52.222-3, Convict Labor (JUNE 2003) (E.O. 11755). 52.222-21 Prohibition of Segregated Facilities (Apr 2015) 52.222-26 Equal Opportunity (Apr 2015) (E.O. 11246). 52.222-35 Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212). 52.222-36 Affirmative Action for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). 52.222-37 Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212). 52.222-40 Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496). 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving (AUG 2011) (E.O. 13513). 52.225-13 Restrictions on Certain Foreign Purchase (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). 52.232-33 Payment by Electronic Funds Transfer System for awards Management (JUL 2013) (31 U.S.C. 3332). Full text copies of the representations and certifications for other cited provisions and clauses many be obtained online at the NCI website at http://ncioa.cancer.gov/oa-internet/reference.jsp or from Kathy Elliott, Contract Specialist at Elliottk@mail.nih.gov. OFFERORS INSTRUCTIONS: Offers must be submitted on an SF-1449 with a completed 52.212-3 Offeror Representations and Certifications-Commercial Items-with DUNS Number Addendum, signed by an authorized representative of the offeror OR provide a copy of the valid certification registrations of the offeror's Central Contractor Registration (CCR) and Online Representations and Certifications Applications (ORCA) System for Award Management (SAM) through www.sam.gov. For pricing purposes offerors shall assume no more than 10 samples being sent for analysis during each 12-month period. Quotations must be received in the NCI-OA Contracting Office by 5:00 p.m. EST, on September 9, 2016. Please refer to the solicitation number: N02RC62683-61 on all correspondence. No collect calls will be accepted. Electronic mail quotations will be accepted. All questions shall be in writing and may be addressed to the aforementioned individual noted above. In order to receive an award, contractor must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representation and Certifications Applications (ORCA) through www.sam.gov.