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Tumor Mutational Burden - VISN 15 Full and Open - Attachment

General Information

Document Type:FILE
Posted Date:Dec 02, 2017
Category: Medical Services
Set Aside:N/A

Contracting Office Address

Department of Veterans Affairs;Network Contracting Office (NCO) 15;3450 S 4th Street Trafficway;Leavenworth KS 66048


Page 2 of 2 This announcement is a Presolicitation Notice for 36C25518Q0115. For your awareness, a solicitation will be posted. The VA Network Contracting Office 15 has been tasked to seek commercial laboratories capable of performing breast and prostate Tumor Mutational Burden (Quantitative Genomic Biomarker) using next-generation sequencing (NGS). Potential sources are responsible for the complete performance of the technical aspects of this requirement. The acquisition awarded is anticipated to be firm, fixed-price. The type of solicitation shall be a competed full and open acquisition. No reimbursement will be made for any costs associated with providing information in response to this notice or any follow up information requested. The duration of this requirement is for a base period (start and end dates to be determined) with two each one-year option periods. The North American Industrial Classification System (NAICS) Code applicable to this acquisition is 621511. The Small Business Size Standard for this acquisition is $32.5M. Participating Medical Center are identified below: Department of Veterans Affairs Kansas City VA Medical Center 4801 Linwood Blvd. Kansas City, Mo. 64128-2226 Department of Veterans Affairs Dwight D. Eisenhower VA Medical Center 4101 S. 4th St. Leavenworth, Ks.66048-5014 Department of Veterans Affairs Marion VA Medical Center 2401 West Main St. Marion, IL. 62959-1188 Department of Veterans Affairs Colmery O Neil VA Medical Center 2200 Gage Blvd. Topeka, Ks. 66622-0001 Department of Veterans Affairs Robert J. Dole VA Medical Center 5500 E. Kellogg Drive Wichita, Ks. 67218-1607 Description of Services: The Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide comprehensive genomic profile services. Genetic Laboratory services include, but are not limited to: specimen storage; transportation of clinical laboratory specimens; performance of analytical testing; reporting of analytical test results; and consultative services. The two types of testing shall provide a fully informative genomic profile for hematologic cancers (leukemia, lymphoma, and myeloma) sarcomas and pediatric cancers, designed to provide physicians with clinically accountable information to guide treatment options for patients based on the genomic profile of their cancer. Comprehensive Genomic Biomarker (Next Generation Sequencing) to Predict Response to Immunotherapy for Hematologic Cancers Comprehensive Genomic Biomarker (Next Generation Sequencing) to Predict Response to Immunotherapy for Solid Tumor The comprehensive genomic profile shall apply next-generation sequencing to identify all four types of genomic alterations across all genes known to be unambiguous drivers of solid tumors with high accuracy. The test simultaneously sequences the coding region of 315 cancer-related genes plus introns from 28 genes often rearranged or altered in cancer to a typical median depth of coverage of greater than 500X. Each covered read represents a unique DNA fragment to enable the highly sensitive and specific detection of genomic alterations that occur at low frequencies due to tumor heterogeneity, low tumor purity and small tissue samples. The test shall detect all classes of genomic alterations, including base substitutions, insertions and deletions (indels), copy number alterations (CNAs), and rearrangements using a small, routine formalin-fixed paraffin-embedded (FFPE) sample (including core or fine needle biopsies). General Qualifications: Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation shall be considered. The Contractor shall have all licenses, permits, accreditation and certificates required by law. The reference laboratory shall be licensed/accredited by the College of American Pathologists (CAP). In addition, the laboratory must be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988. Contractor Personnel assigned by the Contractor to perform the services covered by this BPA shall be eligible to provide the services of this BPA and licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by Contractor personnel working on this BPA shall be full and unrestricted licenses. Contractor personnel shall be licensed by the governing or cognizant licensing board. All interested companies must be registered in SAM (http://www.sam.gov/) to be eligible for award of government contracts. Point of Contact: Paula Galvin, NCO 15 Contracting Office: paula.galvin@va.gov. Please reference the following solicitation number in the subject line of all correspondence submitted: 36C25518Q0115. Note: Only e-mail responses will be accepted.

Original Point of Contact

POC Paula Galvin

Place of Performance

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Link: FBO.gov Permalink
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