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Insight Molecular (IMDX) taps Quest Diagnostics for GraftAssureCore test collection

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Insight Molecular Diagnostics Inc. entered into a material Specimen Collection Agreement with Quest Diagnostics Incorporated on February 20, 2026. Quest Diagnostics will provide specimen collection-related services for samples on which Insight will perform its GraftAssureCore™ blood test, which measures donor-derived cell free DNA using a PCR-based platform.

The parties also agreed that, for a specified period, they will use commercially reasonable efforts to negotiate in good faith additional rights related to the GraftAssure technology. Fees will be paid to Quest Diagnostics for the services under this agreement.

Positive

  • None.

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Insights

Insight links GraftAssureCore™ test to Quest’s collection network.

The agreement with Quest Diagnostics gives Insight Molecular Diagnostics access to professional specimen collection services for its GraftAssureCore™ dd-cfDNA blood test. Operationally, this can support broader test availability by leveraging Quest’s established infrastructure for handling patient specimens.

The arrangement includes fees payable to Quest for services and a commitment for both parties to negotiate in good faith over additional rights to the GraftAssure technology for a specified period. The actual impact will depend on the negotiated terms and the volume of tests routed through this relationship.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (date of earliest event reported): February 20, 2026

 

Insight Molecular Diagnostics Inc.

(Exact name of registrant as specified in its charter)

 

California   1-37648   27-1041563
(State or other jurisdiction   (Commission   (IRS Employer
of incorporation)   File Number)   Identification No.)

 

2 International Plaza Dr., Suite 510

Nashville, Tennessee 37217

(Address of principal executive offices) (Zip code)

 

(615) 255-8880

(Registrant’s telephone number, including area code)

 

N/A

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, no par value   IMDX   The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 
 

 

Item 1.01. Entry into a Material Definitive Agreement.

 

On February 20, 2026, Insight Molecular Diagnostics Inc. (the “Company”) entered into a Specimen Collection Agreement (the “Agreement”) with Quest Diagnostics Incorporated (“Quest Diagnostics”). Pursuant to the Agreement, Quest Diagnostics will provide certain specimen collection-related services related to specimens upon which Provider will perform a GraftAssureCore™ test, a blood test designed to measure donor-derived cell free DNA (dd-cfDNA) using a novel PCR-based measurement platform, for potential patient registrants. The Agreement provides for certain fees to be paid to Quest for services rendered.

 

In addition, each of the Company and Quest Diagnostics agree that, for a specified period, the parties will use commercially reasonable efforts to negotiate, in good faith, certain additional rights to the GraftAssure technology.

 

The foregoing description of the Agreement does not purport to be complete and is subject to, and qualified in its entirety by reference to the full text of the Agreement, a copy of which the Company intends to file as an exhibit to a subsequent periodic report or on an amendment to this Current Report on Form 8-K.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 
 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  INSIGHT MOLECULAR DIAGNOSTICS INC.
     
Date: February 26, 2026 By: /s/ Peter Hong
    Peter Hong
    Vice President, General Counsel

 

 

FAQ

What agreement did Insight Molecular Diagnostics (IMDX) announce with Quest Diagnostics?

Insight Molecular Diagnostics entered a Specimen Collection Agreement with Quest Diagnostics. Quest will provide specimen collection-related services for samples used in Insight’s GraftAssureCore™ donor-derived cell free DNA blood test, supporting the operational delivery of this assay to potential patient registrants.

How does the Quest Diagnostics agreement support Insight Molecular Diagnostics’ GraftAssureCore test?

Quest Diagnostics will handle specimen collection-related services for samples on which Insight performs its GraftAssureCore™ test. This links Insight’s PCR-based dd-cfDNA testing platform to Quest’s collection capabilities, helping enable consistent sample acquisition and processing across potential patient registrants.

Does Insight Molecular Diagnostics pay Quest Diagnostics under this new agreement?

Yes. The agreement provides for specified fees to be paid to Quest Diagnostics for the specimen collection-related services it performs. These payments compensate Quest for handling samples that Insight subsequently tests using its GraftAssureCore™ donor-derived cell free DNA blood assay.

Are there plans to expand Quest’s rights to Insight’s GraftAssure technology?

Insight Molecular Diagnostics and Quest Diagnostics agreed to use commercially reasonable efforts, for a specified period, to negotiate in good faith additional rights related to the GraftAssure technology. Any expansion would depend on the outcome of those future negotiations between the parties.

What is Insight Molecular Diagnostics’ GraftAssureCore test mentioned in the Quest agreement?

GraftAssureCore™ is described as a blood test designed to measure donor-derived cell free DNA using a novel PCR-based measurement platform. Under the new agreement, Quest Diagnostics provides specimen collection-related services for samples on which Insight performs this transplant-focused test.

Is the full Quest Diagnostics agreement with Insight Molecular Diagnostics publicly available?

The company states that the brief description of the Specimen Collection Agreement is not complete. Insight Molecular Diagnostics intends to file the full text of the agreement as an exhibit to a subsequent periodic report or an amendment to a future filing.

Filing Exhibits & Attachments

3 documents
Insight Molecular Diagnostics Inc.

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