Special Notice Special Notice Page 4 of 4 Special Notice *= Required Field Special Notice Page 1 of 4 SUBJECT* Industry Day Virtual National Precision Oncology Minimal Residual Disease (MRD) Testing GENERAL INFORMATION CONTRACTING OFFICE S ZIP CODE* 22408-2697 SOLICITATION NUMBER* 36C10G22Q0028 ARCHIVE 30 DAYS AFTER THE RESPONSE DATE RECOVERY ACT FUNDS N PRODUCT SERVICE CODE* Q301 NAICS CODE* 621511 CONTRACTING OFFICE ADDRESS U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697 POINT OF CONTACT* Darrell Williamson
[email protected] ADDITIONAL INFORMATION AGENCY S URL URL DESCRIPTION AGENCY CONTACT S EMAIL ADDRESS EMAIL DESCRIPTION DESCRIPTION Industry Day Virtual Conference: National Precision Oncology Minimal Residual Disease (MRD) Testing ---------------------------------------------------------- The Department of Veterans Affairs (VA) announces an Industry Day Virtual Conference to acquire information from Contractors with capability and expertise in providing molecular testing for Minimal Residual Disease (MRD) in both solid and hematological malignancies. This notice should not be construed (1) as a commitment by the Department of Veterans Affairs to enter into an agreement with any entity participating in the industry day conference, (2) as a commitment to issue a solicitation, or (3) as a request for proposals. This Industry Day will be held on January 19, 2022 from 10:00 AM until approximately 4:00 PM as a Virtual Event. VA s National Precision Oncology MRD Testing Industry Day will focus on the capability, capacity, and viability of private industry to provide best business solutions for the enablement of MRD testing to support oncology clinical care at the VA. The contractor presentation focus shall be on molecular testing assays and services for MRD in both solid and hematological malignancies with the scope defined below. If your company would like to participate in the Industry Day, please complete the attached Industry Day Request form included at the end of this notice and send to Darrell Williamson at
[email protected] and Zachary Wilcox at
[email protected] by Wednesday, January 5, 2022 by 3:00 PM Eastern Time. The North American Industry Classification System Code (NAICS) is 621511 Medical Laboratories. Scope:Â The objective of the event is to conduct market research and acquire information for a potential molecular testing solicitation. The VA invites contractors providing MRD testing in both solid and hematological malignancies with a focus on assessment and recurrence monitoring for patients previously diagnosed with cancer. Molecular testing intended for non-invasive early cancer detection is not within scope for this industry day event. Industry Day presentations must cover (at a minimum), the following scope and/or capabilities: Testing methodology (to include considerations such as array based, next generation sequencing, ctDNA, tumor informed, methylation signatures, genome wide vs targeted approach, etc). Test performance, in particular sensitivity and specificity including performance comparison to other competing products on the market. Intended cancer types for the test including supporting data on test validation in those cancer types, both by contractor and independent groups. Data and evidence around clinical validity and clinical utility of tests including incorporation into professional guideline recommendations. Regulatory status if FDA approved or submitted to the FDA. Turnaround times for testing and return of results to providers. Example clinical grade patient reports and contractor s ability to return data to the VA in structured formats via secure file transfer mechanisms. Roadmap for contractor s planned improvements to current tests and technology or future availability of new MRD tests. Information on market adoption and the use of testing by academic medical centers or NCI comprehensive cancer centers. Registration for this Industry Day is on a first come, first served basis and must be completed no later than January 5, 2022. INDUSTRY DAY REQUEST Company Name: Point of Contact Information: Company Socio-Economic Status: Company Business Size for NAICS Code Does your company have a Federal Supply Schedule Contract for these services and if so, what is the contract number and the FSS Contracting Officer point of contact information? Please provide a copy of your capabilities statement for your company when replying to this posting.