Purchase sufficient Clearlab kits and reagents to perform WGS (Whole Genome Sequencing) using the Clear Dx system & to sequence SARS-CoV-2 samples.

MSSISSIPPI STATE DEPARTMENT OF HEALTH

Notice of Proposed Sole Source Purchase #0301-0134

RFx # 3150006814

The Mississippi State Department of Health anticipates purchasing the item(s) listed below as a sole source purchase. Anyone objecting to this purchase shall follow the procedures outlined below.

Commodity or commodities to be purchased (make, model, description):

The Centers for Disease Control and Prevention (CDC) has specific protocols and instruments that must be used to perform Whole Genome Sequencing (WGS) for submission of test results to the PulseNet database. PulseNet is a national laboratory network that connects foodborne illness cases to detect outbreaks by using DNA sequencing of bacteria to detect local and multistate outbreaks. The PulseNet database is used to monitor and track foodborne outbreaks and can determine if MS is part of a specific food related outbreak. The Mississippi Public Health Laboratory (MPHL) currently possesses one (1) Clear Labs Clear Dx system to perform WGS on foodborne isolates submitted to the MPHL for testing. The Clear Dx system workflow is fully automated and includes nucleic acid extraction, library preparation, and sequencing. The MPHL would like to purchase sufficient Clear Labs kits and reagents to perform WGS using the Clear Dx system. The MPHL also performs WGS on SARS-CoV-2-positive clinical and wastewater samples to detect mutations and variants circulating in the MS population. Clear Labs kits and reagents to sequence SARS-CoV-2 samples are also included in the product list.

Explanation of the need to be fulfilled by this item(s) and why it is the only one that can meet the

specific needs of the department:

Only Clear Labs kits and reagents approved by the manufacturer can be used to perform WGS on the Clear Dx system. WGS testing results must be uploaded into the PulseNet national database within seven (7) days of specimen receipt in the laboratory. To maintain sufficient kits and reagents to perform WGS testing, an ample supply of kits and reagents listed above must be on-hand to support testing for a large quantity of foodborne isolates submitted from hospitals to the MPHL for testing and meet the turn-around-time within seven (7) days. The MPHL receives over 1000 foodborne specimens annually for WGS testing. WGS results for SARS-CoV-2 are uploaded in the data pipelines for surveillance.

Name of company/individual selling the item and why that source is the only possible source that can provide the required item(s):

The kits and reagents used on the Clear Dx system for WGS are manufactured and distributed only by Clear Labs. Clear Labs does not use distributors in the clinical market and sells directly to laboratories.

Estimated cost of item(s) and an explanation why the amount to be expended is considered reasonable:

• Estimated Cost for kits and reagents: $221,872.00 for the quoted period

• Shipping & Insurance/Handling Fee: $4,200.00 for the quantity of kits included in the quote.

Explanation of the efforts taken by the department to determine this is the only source and the

efforts used to obtain the best possible price:

• Clear Labs is the sole manufacturer and sole vendor of the listed products and sells directly to laboratories.

• Only Clear Labs test reagents can be used on the Clear Dx system.

• All applicable discounts were explored and applied.

Any person or entity that objects and proposes that the commodity listed is not sole source and can be provided by another person or entity shall submit a written notice to: Cynthia Brasher, Mississippi State Department of Health Purchasing Department, 570 E. Woodrow Wilson, Room 134 Underwood Building, Jackson, MS 39216 or P. O. Box 1700, Jackson, MS 39215-1700.

Responses may be hand delivered, via regular mail, overnight delivery or by e-mail: Cynthia.Brasher@msdh.ms.gov . The envelope or e-mail should reference the sole source number.

The notice shall contain a detailed explanation of why the commodity is not a sole source procurement. Appropriate documentation shall also be submitted if applicable. The enclosed form (OSS) may be used if you so desire.

If after a review of the submitted notice and documents, Mississippi State Department of Health determines that the commodity in the proposed sole source request can be provided by another person or entity, then Mississippi State Department of Health will withdraw the sole source request publication from the procurement portal website and submit the procurement of the commodity to an advertised competitive bid or selection process.

If Mississippi State Department of Health determines after review that there is only one (1) source for the required commodity, the Mississippi State Department of Health will appeal to the Public Procurement Review Board. Mississippi State Department of Health will have the burden of proving that the commodity is only provided by one (1) source.

Notices/objections, etc. will be accepted at any time prior to: May 14, 2026 at 3:00 p.m. (CST)