36C25026Q0548.docx

Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 10 Suite 210 3140 Governors Place Blvd Kettering OH 45409-1337

POINT OF CONTACT*

Contract Specialist Cierra S. Joshua Cierra.Joshua@va.gov 734-222-7154

PLACE OF PERFORMANCE

4646 John R Street

Detroit MI

ADDITIONAL INFORMATION

DESCRIPTION

Sources Sought Notice

SOURCES SOUGHT NOTICE

For Octave Lab Testing Services for the John D. Dingell Department of Veterans Affairs Medical Center, Detroit, MI This is a Sources Sought Notice. This advertisement is not a solicitation for offers, nor is it a request for quotes. A request for quotes may be issued at a later date.

This Sources Sought/Market Survey Notice is being conducted by the Network 10 Contracting Office, 24 Frank Lloyd Wright Drive, Ste. M2200, Ann Arbor, MI 48105 to determine if responsible sources exist and if there are any businesses capable of providing the requirements listed herein. The proposed NAICS Code is 541380, Testing Laboratories and Services ($19 Million Size Standard).

Period of Performance: 12 months from date of Award

Responses must include: (1) Business Name, GSA contract number (if applicable) and Address; (2) Point of Contact Name, Phone Number, and E-mail Address; (3) SAM UEID Number and NAICS code; (4) Business Size: are you SMALL or LARGE; and (5) Type of Business SERVICE-DISABLED VETERAN OWNED, VETERAN OWNED, 8A, HUB Zone, WOMEN-OWNED etc. All businesses eligible to provide this service are encouraged to reply as this information may be used to determine potential set asides for the above noted service. (6) Technical Capabilities that align with SOW and provide applicable certifications.

Prospective offerors shall respond to this Sources Sought no later than 2:00pm (Eastern), Wednesday, May 6, 2026. Send all replies to Cierra S. Joshua at Cierra.Joshua@va.gov. All responses shall include 36C25026Q0548 in the subject or body of the email.

Note: This is a Sources Sought Notice only and is not a request for proposals. No reimbursement will be made for any costs associated with providing information in response to this sources sought notice or any follow-up information requests.

Please review the attached Statement of Work (SOW).

STATEMENT OF WORK (SOW)

Octave Multiple Sclerosis Disease Activity (MSDA) Blood Biomarker Testing Services John D. Dingell VA Medical Center 4646 John R Street Detroit, MI 48201

1. GENERAL INFORMATION

1.1 Title: Octave MS Disease Activity (MSDA) Blood Biomarker Test Services

1.2 Scope

The contractor shall provide laboratory testing services for the Octave Multiple Sclerosis Disease Activity (MSDA) blood biomarker assay. The MSDA test is a proprietary, serum-based laboratory-developed test that measures 18 protein biomarkers and produces an overall disease activity score (1–10 scale) with supporting pathway sub-scores related to immunomodulation, neuroinflammation, myelin biology, and neuroaxonal integrity .

Testing shall support clinical management of Veterans diagnosed with Multiple Sclerosis (MS) receiving care through Neurology at the John D. Dingell VA Medical Center (VAMC).

2. BACKGROUND

Multiple Sclerosis (MS) is a chronic inflammatory and neurodegenerative disease requiring ongoing monitoring to guide Disease Modifying Therapy (DMT) decisions. Current monitoring methods rely on clinical examination and MRI, which may not fully capture subclinical disease activity.

The MSDA blood test provides objective and quantitative measurement of disease activity and supports:

Baseline phenotyping DMT selection DMT escalation or de-escalation Longitudinal disease monitoring (approximately every 6–12 months)

This contract establishes access to the proprietary MSDA assay performed exclusively by Octave Bioscience.

3. PERIOD OF PERFORMANCE

Base Year: 12 months from date of contract award Option Years: To be determined (if applicable)

4. PLACE OF PERFORMANCE

Specimen collection:

John D. Dingell VA Medical Center Pathology & Laboratory Medicine Service Detroit, Michigan

Testing location:

Contractor’s CLIA-certified laboratory facility.

5. REQUIREMENTS

5.1 Contractor Responsibilities

The Contractor shall:

1. Provide MSDA testing services utilizing its proprietary 18-biomarker assay and algorithm.

2. Maintain current CLIA certification and all required federal, state, and regulatory laboratory credentials.

3. Provide specimen collection requirements and handling instructions.

4. Supply Test Requisition Forms (TRFs), including pre-filled provider/clinic information when applicable.

5. Receive, process, and analyze submitted specimens.

6. Generate a comprehensive MSDA report including:

Overall Disease Activity Score (1–10 scale) Pathway-specific sub-scores

Individual biomarker concentrations Interpretive guidance

7. Deliver test results securely to ordering VA clinicians within the agreed turnaround time.

8. Provide customer support for ordering, specimen handling, and result interpretation inquiries.

9. Maintain HIPAA compliance and safeguard all Protected Health Information (PHI).

10. Bill the VA laboratory at the agreed contracted price per test.

5.2 VA Responsibilities

The VA shall:

1. Identify Veterans eligible for MSDA testing.

2. Obtain informed consent as clinically required.

3. Perform specimen collection, packaging, and shipment in accordance with contractor instructions .

4. Complete and submit required TRFs with each specimen.

5. Review and incorporate results into clinical decision-making.

6. Provide timely payment in accordance with contract terms.

6. ESTIMATED QUANTITY

The estimated annual contract value is $70,000.

Price per test (as referenced in supporting documentation): $1,349 per MSDA test.

Estimated test volume will be based on Neurology clinic utilization and MS patient population needs.

No minimum quantity is guaranteed.

7. QUALITY ASSURANCE

The Contractor shall:

Maintain laboratory accreditation and CLIA compliance.

Ensure analytical validity and quality controls consistent with industry standards.

Provide corrective action plans if testing discrepancies are identified.

Participate in any required VA quality review processes.

8. TURNAROUND TIME

Standard turnaround time shall be defined in the contract but is expected to align with routine reference laboratory testing standards from receipt of specimen to final report issuance.

9. SECURITY REQUIREMENTS

The Contractor shall:

Comply with HIPAA and all applicable federal privacy laws.

Ensure secure transmission of results.

Protect Veteran health information at all times.

No VA network access is required.

10. BILLING AND INVOICING

The Contractor shall submit invoices in accordance with VA payment procedures.

Invoices must include:

Veteran identifier (as permitted) Date of service Quantity of tests Unit price Total cost Payment will be made via authorized VA payment system upon verification.

11. GOVERNMENT-FURNISHED PROPERTY

None.

12. KEY PERSONNEL

Clinical Lead:

Dr. Anza B. Memon – Neurology Administrative Lead: Rocky DeBose – Administrative Officer, Integrated Clinical Services Laboratory Coordination:

Pathology & Laboratory Medicine Service

13. SPECIAL REQUIREMENTS

Contractor must maintain continuous CLIA certification.

Contractor must notify VA immediately of any regulatory changes affecting testing services.

Contractor shall provide updated testing methodology documentation if modifications occur during the contract period.

14. ACCEPTANCE CRITERIA

Services will be considered acceptable when:

Specimens are processed accurately.

Reports are delivered timely.

All required scoring components are included.

Regulatory compliance is maintained.

Failure to meet requirements may result in corrective action or contract termination.

15. SUMMARY

This Statement of Work establishes a service contract for the proprietary Octave MSDA blood biomarker assay to support evidence-based, precision management of Veterans with Multiple Sclerosis. The service provides objective disease activity measurement to assist in DMT selection, escalation, de-escalation, and longitudinal monitoring .

Page 1 of