Souces Sought ClonoSEQ.pdf

Version – July 2015

SOURCES SOUGHT

Brooke Army Medical Center, Fort Sam Houston TX

Clono-SEQ

INTRODUCTION

This is a Sources Sought Notice ONLY. The United States Army is planning to justify brandname(s) requirement to procure FDA-cleared in vitro diagnostic (IVD) testing services from Adaptive Biotechnologies Corportation for ClonoSEQ.

The Medical Readiness Contracting Office-West, Fort Sam Houston, TX is issuing this sources sought synopsis as a means of conducting market research to identify parties having an interest in and the resources to support the requirement for IVD Testing Services for Brooke Army Medical Center.

Accordingly, the U.S. Government highly encourages all interested businesses (large and small) to respond to this sources sought synopsis. In addition, small businesses, in all socioeconomic categories (including, 8(a) Business Development Program, Small Disadvantage Business, Historically Underutilized Business Zone, Service-Disabled Veteran-Owned, Women-Owned Small Business concerns), must describe their identifying capabilities in meeting the requirements at a fair market price, i.e., information which may help support a set-aside.

DISCLAIMER

“THIS SOURCES SOUGHT IS FOR INFORMATIONAL PURPOSES ONLY. THIS

IS NOT A “REQUEST FOR PROPOSAL (RFP)” TO BE SUBMITTED. IT DOES

NOT CONSTITUTE A SOLICITATION AND SHALL NOT BE CONSTRUED AS A

COMMITMENT BY THE GOVERNMENT. RESPONSES IN ANY FORM ARE NOT

OFFERS AND THE GOVERNMENT IS UNDER NO OBLIGATION TO AWARD A

CONTRACT AS A RESULT OF THIS ANNOUNCEMENT. NO FUNDS ARE

AVAILABLE TO PAY FOR PREPARATION OF RESPONSES TO THIS

ANNOUNCEMENT. ANY INFORMATION SUBMITTED BY RESPONDENTS TO

THIS TECHNICAL DESCRIPTION IS STRICTLY VOLUNTARY. RESPPONSES

WILL NOT BE RETURNED TO THE RESPONDER. NOT RESPONDING TO THIS

NOTICE DOES NOT PRECLUDE PARTICIPATION IN ANY FUTURE REQUEST

FOR QUOTE (RFQ) OR INVITATION FOR BID (IFB) OR RFP, IF ANY ISSUED. IF

A SOLICITATION IS RELEASED, IT WILL BE SYNOPSIZED ON THE

GOVERNMENT-WIDE POINT OF ENTRY (GPE). IT IS THE RESPONSIBILITY

OF POTENTIAL OFFERORS TO MONITOR THE GPE FOR ADDITIONAL

INFORMMATION PERTAINING TO THIS REQUIREMENT.”

PROGRAM BACKGROUND

The Brooke Army Medical Center (BAMC), Department of Pathology is requesting a new highly specialized laboratory testing service requirement. ClonoSEQ® is available as an FDA-cleared in vitro diagnostic (IVD) test service provided by Adaptive Biotechnologies to detect measurable residual disease (MRD) in bone marrow from patients with multiple myeloma or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL).

Additionally, ClonoSEQ® is available for use in other lymphoid cancers and specimen types as a CLIA-validated laboratory developed test (LDT). The ClonoSEQ® Assay measures minimal residual disease (MRD) to monitor changes in burden of disease during and after treatment. The test is indicated for use by qualified healthcare professionals in accordance with professional guidelines for clinical decision-making and in conjunction with other clinicopathological features.

REQUIRED CAPABILITIES

The Contractor shall provide IVD Testing services in support of the areas specified in Program Background (above). Further detail is provided in the draft Statement of Work (SOW) attached to this announcement (Attachment 1).

If your organization has the potential capacity to perform these contract services, please provide the following information: 1) Organization name, address, email address, Web site address, telephone number, and size and type of ownership for the organization;

and 2) Tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability. If significant subcontracting or teaming is anticipated in order to deliver technical capability, organizations should address the administrative and management structure of such arrangements.

The Government will evaluate market information to ascertain potential market capacity to: 1) provide services consistent, in scope and scale, with those described in this notice and otherwise anticipated; 2) secure and apply the full range of corporate financial, human capital, and technical resources required to successfully perform similar requirements; 3) implement a successful project management plan that includes:

compliance with tight program schedules; cost containment; meeting and tracking performance; hiring and retention of key personnel and risk mitigation; and 4) provide services under a performance based service acquisition contract.

ELIGIBILITY

The NAICS code(s) used for this notice is NAICS 621511 Medical Laboratories. The code has a size standard of $41.5 Million. This NAICS code is used for the purpose of this notice only. Future purchases may use a different NAICS depending on the total requirement. If you believe the suggested NAICS is not appropriate for the requirement, please suggest a NAICS and explain why it is more appropriate for this type of acquisition. In response to this sources sought, please provide the following:

•Offeror’s name, address, point of contact, phone number, and e-mail address.

•Offeror’s interest in providing a proposal/quote on the solicitation when it is issued.

•Offeror’s capability to meet personnel requirements.

•Offeror’s must provide documentation that they are qualified, and manufacture trained on the listed laser equipment. Offeror must provide documented proof of successful completion and certification of such training.

•Offeror’s capability to perform a contract of this magnitude and complexity (include offeror’s in-house capability to provide the endoscopy reporting system. Please provide three (3) examples. Documentation of appropriate products must be presented in sufficient detail for the Government to determine that your company possesses the necessary means to compete for this acquisition.

•Offeror’s type of small business and Business Size (Whether 8(a), HUB Zone, Women- Owned Small Business, Service-Disabled Veteran Owned Small Business, etc.), or Large Business Status, should be documented in the Statement of Capability.

Interested parties are responsible for marking information that is proprietary in nature.

No reimbursement will be made for any costs associated with providing information in response to this notice or any follow up information requests. The Government is not obligated to, nor will it, pay for or reimburse any costs associated with responding to this sources sought notice. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. No subcontracting opportunity is anticipated. A determination by the Government to not compete this proposed contract action based on the responses to this notice is solely within the discretion of the Government.

Questions for this sources sought shall be submitted on or before 12:00PM CDT on 20 January 2025.

Interested Offeror shall respond to this Sources Sought Notice no later than 07 February 2025 at 12:00 pm, Central time. All interested businesses must be registered in the System for Award Management (SAM) at www.sam.gov to be eligible for award of Government contracts. E-mail your response Colleen M. Rye, Contract Specialist at email: colleen.m.rye.civ@health.mil and Salameya Paulouskaya, Contracting Officer, salameya.paulouskaya2.civ@health.mil Please label the email, “PANHCA-24-P-0000-007774 ClonoSEQ Sources Sought Response. Telephonic inquiries will not be honored. EMAIL IS THE ONLY METHOD.

The Government will not return any information submitted in response to this notice.

This synopsis is for information and planning purposes only and is not to be construed as a commitment by the Government nor will the Government pay for information solicited. Respondents will not be notified of the results of the evaluation. No telephonic responses will be accepted. No solicitation currently exists; therefore, do not request a copy of the solicitation. If a solicitation is released it will be synopsized in www.sam.gov.

It is the potential offerors responsibility to monitor this site for the release of any solicitation or synopsis.

Primary Point of Contact: Secondary Point of Contact:

Colleen M. Rye Salameya Paulouskaya Contract Specialist Contracting Officer Email: colleen.m.rye.civ@health.mil Email: salameya.paulouskaya2.civ@health.mil