SOLE-SOURCE DETERMINATION MEMO

FOR SUPPLIES AND SERVICES - Final

Date: February 10, 2026 Sole source number:

S-44300-00016838

To: Kirk N. Rhoades, Designated Procurement Officer ODHS Office of Contracts & Procurement

Requestor: Elizabeth Stelle Agency/division: Oregon Health Authority/Public Health Division, herein after referred to as “Agency” Program/office: Center for Public Health Practice/Public Health Laboratory Contract specialist:

Agency Sole source rule: Sole source authority:

DHS OAR 125-247-0275 OAR 125-246-0170(2)

OHA OAR 137-047-0275 ORS 413.033

Estimated total contract value: $250,000 over a period of 5 years

Description of goods or services: DiaSorin Liaison XS and Liaison MDX instrument systems, including consumables, maintenance/service, software, or other supplies required for use of these instrument systems

1. Background: This sole source justification applies to the purchase of Liaison XS and Liaison MDX instrument systems from DiaSorin, including consumables, maintenance/service, software, or other supplies required for use of these instrument systems.

The DiaSorin Liaison XS is a bench-top, chemiluminescent immunoassay analyzer.

Chemiluminescent Immunoassay analyzers are designed to detect and quantify a targeted substance in a sample by measuring the light produced in a chemical reaction occurring in a sample well. These assays are developed to be highly specific and highly sensitive – able to detect very small amounts of the targeted substance with minimal interference and false positives. Multiple infectious diseases are detectable with the DiaSorin Liaison XS, which supports assays designed to detect Mycobacterium tuberculosis (TB), Lyme Disease, Syphilis, Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), among others. The Oregon State Public Health Laboratory (OSPHL) primarily intends to use this instrument for the detection of TB, but the availability of other assays for this instrument provides OSPHL and opportunity to expand testing in the future, and it provides a secondary methodology for many infectious diseases identified at OSPHL, which contributes to resilience and emergency preparedness goals.

Tuberculosis was named a global health emergency by the World Health Organization in 1993, and the disease remains a serious public health concern.

While the incidence of TB in Oregon remains below the national average, the number of diagnosed cases has been increasing since 2020. OSPHL performs the diagnostic testing for the Oregon Health Authority’s Tuberculosis Program, and effective, reliable testing is critical for meeting the Oregon Health Authority’s goals of eliminating health inequities.

There are multiple options for TB testing available, but diagnostic blood testing is generally performed using an Interferon Gamma-Release Assay, which identifies the disease by detecting a byproduct of the bacterial infection in a blood sample.

The IGRA method has been demonstrated to be sensitive enough to detect latent infection and results are unaffected by prior vaccination. QuantiFERON was the first IGRA approved for use in the United States, and OSPHL currently uses the QuantiFERON enzyme-linked immunosorbent assay (ELISA).

DiaSorin provides the only commercially available and FDA-approved analyzer to use the chemiluminescence method for TB testing, and QuantiFERON producer Qiagen has adapted their highly reliable test process to be utilized with the DiaSorin Liaison instruments. These are also the only instruments that allow continuous loading of samples, which is preferable to batch testing because results are available more quickly and there is less waste of consumables. The DiaSorin Liaison XS is a smaller analyzer than the XL model, which will utilize the available space at OSPHL most efficiently.

The DiaSorin Liaison MDX is a real-time polymerase chain reaction (PCR) thermocycler for the amplification of genetic material and detection of pathogens.

DiaSorin is not the only manufacturer of this type of instrument, and OSPHL utilizes multiple thermocyclers from other manufacturers. However, the DiaSorin Liaison MDX is the only commercially available instrument that has received FDA approval to identify Candida auris colonization using all-in-one prepackaged reagent kits.

Candida auris is a fungal pathogen that has become a source of concern nationally and globally due to its resistance to multiple anti-fungal drugs. The drug resistance, increased incidence, and ability cause severe infection or death have made this organism an emerging threat. Traditional PCR methods to detect C auris include significant handling of the specimen. An all-in-one system reduces laboratory labor, but it also decreases the risk of exposure and potential infection for laboratory staff. Currently, OSPHL does not test for C auris, but with the rising interest in this organism, the ability to provide efficient, safe identification will be critical to support Oregonians in the near future.

With DiaSorin established as a sole source of these instruments, OSPHL intends to purchase the DiaSorin Liaison XS instrument and the applicable consumable goods needed to perform TB testing. The QuantiFERON testing reagents are available through Qiagen, and OSPHL will utilize the existing agreement with Qiagen to purchase those items. OSPHL may establish an agreement with DiaSorin to manage the ongoing need for instrument service (maintenance and repairs). This agreement will be amended to include additional instruments (Liaison XS or Liaison MDX) and consumables when and if OSPHL identifies the need to begin testing for C auris or other infectious organisms available for these platforms.

2. Prospective contractor/vendor:

Legal entity name:

DiaSorin Molecular LLC

DBA:

Address: 11331 Valley View St, Cypress CA 90630 Contact person: Lance Ferestad Phone: 651-571-6270 Email: lance.ferestad@diasorin.com

Protests are due by 3:00 PM within seven calendar days after the first date the notice is posted on OregonBuys. Protests must be sent via mail, fax, email, or hand carried to the following address: Protests via telephone will not be accepted.

Oregon Department of Human Services

Office of Contracts and Procurement

ATTN:

Address:

Phone: Fax: 503-378-4324 Email:

Agency reserves the right to purchase additional goods, services to include on-call maintenance, preventative maintenance, repair (unless available on DAS price agreement), or training.

3. Written findings of fact (market research):

The findings below must include factual information supporting the determination that meet the sole source requirement in statute.

Pursuant to ORS 279B.075, Agency must conduct market research that supports the assertion that there is only one source that can provide the goods or services.

Market research includes utilization of the internet, trade journals, agency vendor lists, professional organizations, studies, catalogs/industrial periodicals, vendor sources, yellow pages, etc.

For information technology contracts, any ownership or proprietary issues should be fully addressed with written documentation to support facts.

Agency must select at least one of the findings and prepare the determination as it specifically relates to the good or service being procured. More than one finding can be addressed. The findings are as follows:

Pursuant to ORS 279B.075 (2)(a): Provide findings supporting the determination that the efficient utilization of existing goods requires the acquisition of compatible goods or services from only one source.

or Pursuant to ORS 279B.075 (2)(b): Provide findings supporting the determination that the goods or services required for the exchange of software or data with other public or private agencies are available from only one source.

or

Pursuant to ORS 279B.075 (2)(c): Provide findings supporting the determination that the goods or services are for use in a pilot or an experimental project.

or Pursuant to ORS 279B.075 (2)(d): Any other findings that support the conclusion that the goods or services are available from only one source.

DiaSorin has provided the attached letters which state that they are the sole manufacturer and supplier of these instruments in the United States. Market research indicates that the DiaSorin Liaison XS and XL are the only chemiluminescent immunoassay analyzers approved to perform TB testing with the QuantiFERON method, and there are no traditional ELISA analyzers that can support continuous sample loading for TB testing. The DiaSorin Liaison MDX is the only all-in-one PCR system that has received FDA approval for clinical use in identifying Candida auris.

APPROVED:

By:

Signed by DPO electronically via OregonBuys Kirk N. Rhoades or acting DPO

BRAND NAME DETERMINATION:

If a brand name is involved, Agency must also satisfy the requirements of OAR 125- 247-0691 by completing Attachment 1.

ATTACHMENT 1

DETERMINATION OF BRAND NAME SPECIFICATION

Requestor: Elizabeth Stelle Agency/division: Oregon Health Authority/Public Health Division, herein after referred to as “Agency” Program/office: Center for Public Health Practice/Public Health Laboratory

Agency Brand name statute/rule: Brand name authority:

DHS OAR 125-247-0691 OAR 125-246-0170(2)

OHA ORS 279B.215 ORS 413.033

Total estimated cost: $250,000 over a period of 5 years

1. Background: This sole source justification applies to the purchase of Liaison XS and Liaison MDX instrument systems from DiaSorin, including consumables, maintenance/service, software, or other supplies required for use of these instrument systems.

The DiaSorin Liaison XS is a bench-top, chemiluminescent immunoassay analyzer.

Chemiluminescent Immunoassay analyzers are designed to detect and quantify a targeted substance in a sample by measuring the light produced in a chemical reaction occurring in a sample well. These assays are developed to be highly specific and highly sensitive – able to detect very small amounts of the targeted substance with minimal interference and false positives. Multiple infectious diseases are detectable with the DiaSorin Liaison XS, which supports assays designed to detect Mycobacterium tuberculosis (TB), Lyme Disease, Syphilis, Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), among others. The Oregon State Public Health Laboratory (OSPHL) primarily intends to use this instrument for the detection of TB, but the availability of other assays for this instrument provides OSPHL and opportunity to expand testing in the future, and it provides a secondary methodology for many infectious diseases identified at OSPHL, which contributes to resilience and emergency preparedness goals.

Tuberculosis was named a global health emergency by the World Health Organization in 1993, and the disease remains a serious public health concern.

While the incidence of TB in Oregon remains below the national average, the number of diagnosed cases has been increasing since 2020. OSPHL performs the diagnostic testing for the Oregon Health Authority’s Tuberculosis Program, and effective, reliable testing is critical for meeting the Oregon Health Authority’s goals of eliminating health inequities.

There are multiple options for TB testing available, but diagnostic blood testing is generally performed using an Interferon Gamma-Release Assay, which identifies the disease by detecting a byproduct of the bacterial infection in a blood sample.

The IGRA method has been demonstrated to be sensitive enough to detect latent infection and results are unaffected by prior vaccination. QuantiFERON was the first IGRA approved for use in the United States, and OSPHL currently uses the QuantiFERON enzyme-linked immunosorbent assay (ELISA).

DiaSorin provides the only commercially available analyzer to use chemiluminescence rather than an enzyme-linked method for TB testing, and QuantiFERON producer Qiagen has adapted their highly reliable test process to be utilized with the DiaSorin Liaison instruments. These are also the only instruments that allow continuous loading of samples, which is preferable to batch testing because results are available more quickly and there is less waste of consumables.

The DiaSorin Liaison XS is a smaller analyzer than the XL model, which will utilize the available space at OSPHL most efficiently.

The DiaSorin Liaison MDX is a real-time polymerase chain reaction (PCR) thermocycler for the amplification of genetic material and detection of pathogens.

DiaSorin is not the only manufacturer of this type of instrument, and OSPHL utilizes multiple thermocyclers from other manufacturers. However, the DiaSorin Liaison MDX is the only commercially available all-in-one instrument that has received FDA approval to identify Candida auris colonization from swabs.

Candida auris is a fungal pathogen that has become a source of concern nationally and globally due to its resistance to multiple anti-fungal drugs. The drug resistance, increased incidence, and ability cause severe infection or death have made this organism an emerging threat. Traditional PCR methods to detect C auris include significant handling of the specimen. An all-in-one system reduces laboratory labor, but it also decreases the risk of exposure and potential infection for laboratory staff. Currently, OSPHL does not test for C auris, but with the rising interest in this organism, the ability to provide efficient, safe identification will be critical to support Oregonians in the near future.

With DiaSorin established as a sole source of these instruments, OSPHL intends to purchase the DiaSorin Liaison XS instrument and the applicable consumable goods needed to perform TB testing. The QuantiFERON testing reagents are available through Qiagen, and OSPHL will utilize the existing agreement with Qiagen to purchase those items. OSPHL may establish an agreement with DiaSorin to manage the ongoing need for instrument service (maintenance and repairs). This agreement will be amended to include additional instruments (Liaison XS or Liaison MDX) and consumables when and if OSPHL identifies the need to begin testing for C auris or other infectious organisms available for these platforms.

2. Brand name to be acquired:

Legal entity name:

DiaSorin Molecular LLC

DBA: [Type DBA name, if applicable] Address: 11331 Valley View St, Cypress CA 90630 Contact person: Lance Ferestad Phone: 651-571-6270 Email: lance.ferestad@diasorin.com

3. Findings to satisfy required standards:

Use of a brand name specification is unlikely to encourage favoritism in the awarding of public contracts or substantially diminish competition for public contracts because:

or Use of a brand name specification would result in substantial cost savings to the agency or the public because:

or

There is only one manufacturer or seller of the product of the quality, performance or functionality required; because:

DiaSorin has provided the attached letters which state that they are the sole manufacturer and supplier of these instruments in the United States. Market research indicates that the DiaSorin Liaison XS and XL are the only chemiluminescent immunoassay analyzers approved to perform TB testing with the QuantiFERON method, and there are no traditional ELISA analyzers that can support continuous sample loading for TB testing. The DiaSorin

Liaison MDX is the only all-in-one PCR system that has received FDA approval for clinical use in identifying Candida auris colonization.

or

The efficient utilization of existing goods requires the acquisition of compatible goods or services because:

FINDINGS

The findings are accepted, adopted, and incorporated by reference herein.