8-K

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): June 3, 2021

CAREDX, INC.

(Exact Name of Registrant as Specified in its Charter)

1 Tower Place, 9th Floor

South San Francisco, California 94080

(Address of Principal Executive Offices) (Zip Code)

(415) 287-2300

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 Exchange Act:

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 8.01 Other Events.

On June 3, 2021, CareDx, Inc. (the “Company”) issued a press release announcing the strategic agreement with OrganX. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

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.

Document

Exhibit 99.1

CareDx Advances Artificial Intelligence in Transplantation

Partnership with OrganX to develop decision support systems

SOUTH SAN FRANCISCO, Calif., June 3, 2021 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced it has entered into a strategic agreement with OrganX to develop clinical decision support tools across the transplant patient journey.

Together, CareDx and OrganX will develop advanced analytics that integrate AlloSure, the first transplant specific dd-cfDNA assay, with large transplant databases to provide clinical data solutions. This partnership delivers the next level of innovation beyond multi-modality by incorporating a variety of clinical inputs to create a universal composite scoring system.

“As AlloSure continues to evolve into the standard of care, we have added multi-modality as the next level of innovation for assessing organ injury for transplant recipients,” said Reg Seeto, President and Chief Executive Officer of CareDx. “This partnership with OrganX allows CareDx to further expand our leadership in multi-modality testing by integrating AlloSure into AI platforms.”

“CareDx has established itself as the leading transplant company and its focus on developing an integrated transplant ecosystem makes it an ideal partner for developing multidimensional solutions for transplant patients and healthcare providers,” said Dr. Alex Loupy, Founder, OrganX. “OrganX’s primary objective is to improve the quality of life and life expectancy for patients through translational science and the development of advanced digital health solutions. This partnership with CareDx will allow us to have this type of impact for organ transplant recipients.”

About CareDx

CareDx, Inc., headquartered in South San Francisco, California, is a leading precision medicine solutions company focused on the discovery, development and commercialization of clinically differentiated, high-value healthcare solutions along the pre- and post-transplant patient journey and is the leading provider of genomics-based information for transplant patients. For more information, please visit: www.CareDx.com.

About OrganX

OrganX is an independent nonprofit health organization that fosters research and access to advanced health technologies in order to improve quality of life and life expectancy of patients affected by severe noncommunicable diseases across the world.

Forward Looking Statements

This press release includes forward-looking statements, including statements regarding the Company’s collaboration with OrganX and the potential benefits and results that may be achieved through the collaboration. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including risks that CareDx does not realize the expected benefits of the collaboration; risks related to OrganX's intellectual property protection; general economic and market factors; and other

risks discussed in CareDx's filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2020 filed by CareDx with the SEC on February 24, 2021 and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.

CONTACTS:

CareDx, Inc.

Sasha King

Chief Marketing Officer

415-287-2393

sking@caredx.com

Investor Relations

Greg Chodaczek

347-620-7010

investor@caredx.com