Sole Source Justification_Hologic.docx

SOLE SOURCE JUSTIFICATION FORM:

This completed form is to be submitted to PCU via the Request website as the first step in the Sole Source Process.

Important! Consult the document “Sole Source Justification Guidance” for additional instructions.

TYPE OR CLEARLY PRINT ALL INFORMATION

Project Name: Hologic Wastewater Testing Vendor name: Hologic Sales and Service, LLC.

Vendor Address: 250 Campus Drive Marlborough, MA 01752 Select one: X Original ☐Modification CORE Vendor ID:

PO or Contract Number (if this is a modification):

Describe the products and/or services to be procured and how they meet your needs. (This space is limited – provide a scope of work or specs as additional documentation).

The Wastewater Program at CDPHE, has identified via the national wastewater community of practice workgroup, the application of the panther and panther fusion system’s ability to serve as a flexible, scalable, open source, high throughput, fully automated, rapid, extraction and multiplex capable molecular testing platform for response to surge testing for wastewater samples.

This project is meant to cover the purchase of the instrumentation and service, as well as any Hologic specific reagents needed to run the onboard workflow; it does not cover any Hologic panels as panels for this project will be generated in-house based on our wastewater workflow.

List dates, agreement numbers and dollar amounts for any previously procured products or services from this vendor related to this project:

Term of agreement:

(If multi-year, indicate the full term up to 5 years) Start Date

11/30/2031

amount $1.5M

Increased

Revised Total

If a modification, state the reason(s):

A. Criteria: Answer both 1 and 2.

If “NO” to either 1 or 2, answer 3 and 4, below.

3. The compatibility of equipment, software, accessories, or replacement parts is the paramount consideration and the items are only available from one vendor.

a. Is this a software package or other IT system and the existing system now requires only ongoing maintenance and support?

If “NO” to 1-4, above, this is not a sole source.

STOP

A formal solicitation is required. Complete a Purchasing Determination Form.

Submit all required documents via the PCU Request Site.

B. Explain in terms of 1 through 4, above, the basis for your identifying this as a sole source? A sole source is justified in the instance that this is the only vendor - not what the program may determine to be the best vendor. Is this the only vendor? Explain (See form instructions).

The Panther and Panther Fusion is the only option for onboard extraction and PCR that can run endpoint to endpoint overnight without staff present; allowing rapid results without a change to staffing, while also maintaining the infrastructure, foot print and capacity we would need to respond to urgent wastewater surveillance testing as well as support the utilization of an existing system, for a new application within the routine testing workflow. Additionally, this instrument allows for mixed runs, and on the same instrument, we are able to stagger and/or combine pathogens because each reaction is independent. This reduces cost per sample without impact to turn around time.

Other features that are specific to the Hologic system is that core reagents can be reused for 30 days once opened, and the platform is open access for target development which differs from other market available options. Open access is critical to onboarding our current workflow and not being locked into fixed panels based what is compatible with the instrument.

Hologic is the sole manufacturer and distributor of the instrumentation, service and core reagents identified in this documentation.

C. What makes this good or service unique to meeting your needs?

This instrumentation, service and core reagents meet the following needs:

· Endpoint to endpoint overnight without staff present

· Open access platform

· Foot print and capacity in line with current infrastructure and workflow

· Long shelf life reagents/reusable reagents

· Independent reactions/mix and match pathogen target capable

· Development and Validation plans already exist for Hologic Lab developed tests

E. What type of required, specific and exclusive experience, certifications, licenses etc. are possessed by this vendor that directly relate to the good or service to be procured?

Hologic, Inc. is the original equipment manufacturer (OEM) and the sole authorized provider of the Panther and Panther Fusion systems, including proprietary instrumentation, software, firmware, replacement parts, reagents, and manufacturer-supported service. Hologic possesses the exclusive technical expertise, factory-trained service personnel, proprietary diagnostic software, and access to OEM replacement components required to install, maintain, calibrate, repair, and support these systems in accordance with manufacturer specifications.

Hologic's service engineers are trained and certified on Panther and Panther Fusion instrumentation and have access to proprietary service tools, software updates, engineering documentation, and technical support that are not available to third-party service providers. Manufacturer service is required to maintain instrument performance, system validation, regulatory compliance, and compatibility with FDA-cleared assays and laboratory-developed tests.

Because the Panther and Panther Fusion platforms utilize proprietary hardware, software, consumables, and assay chemistry, no other vendor is authorized or possesses the necessary technical knowledge, OEM parts, or service capabilities to provide equivalent installation, maintenance, repair, software support, or warranty services for these systems.

F. What research has the program conducted to justify this sole source?

The program was made aware of the opportunity to integrate the Hologic Panther and Panther Fusion into the wastewater testing workflow, during an APHL community of practice workgroup meeting. Follow the meeting the program did a market comparison of similar platforms and found that while some combination of requirements can be met by other vendors, only Hologic has an integrated, fully automated, high-throughput, end point to end point, molecular based open access platform.

The vendor options that were compared include, Roche, Abbott, BioMerieux, Cepheid, BD, Qiagen, and Agilent.

If Yes: Please Explain. (This space is limited – please provide additional documentation if applicable.)

H. This Section is Required – You must answer “Yes” to at least one.

3. Did you conduct a cost/price analysis? (If “Yes”, attach documentation)

In buying the equipment and service outright, we maintain our installed equipment at a fraction of the cost of a new instrument, and in doing so we also avoid the downtime of delivery, install, and validation. Additionally, since this instrumentation will serve as a part of our surge testing workflow, it supports low cost per sample throughput without picking between cost or turn around time, it reduces labor costs (runs autonomously overnight) and does not require vendor specific panels for rapid onboarding of emerging threats as it is open source and therefore beyond the core reagents can be customized for target and scale, making it cost effective.

If No to #3 above:

4. Do you know if the cost is "fair and reasonable"?

Although another vendor cannot satisfy the sole source requirement (specifically open source, scalable, end point to end point), the overall market price for similar molecular assay platforms is in line with the Panther and Panther Fusion. In the application of our wastewater workflow, the Hologic platform, is not disproportionately more costly than our manual platform.

Demonstrate how you determined fair and reasonable prices/rates: Attach additional pages if required.

Division: Lab Services Program: Genomic Surveillance Program, Wastewater Unit Program Contact Name: Alexandria Rossheim Phone: 408-529-740 Program Manager: Shannon Matzinger --------------------------------------------------------------------------------------------------------------------------------------------------------------------- Procurement Use Only:------------------ Comments:

Approved: __________________________________________________________________________ Agency Procurement Director or Authorized Representative Signature Date Posted on VSS? Yes ☐ No ☐ If posted, original Intent to Sole Source VSS# __________________________________________

If not posted or modified, Approved CDPHE Request #: _______________________________________

Sole Source Justification 4 Version A2021