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): March 26, 2019

CAREDX, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware	001-36536	94-3316839
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

3260 Bayshore Boulevard

Brisbane, California 94005

(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))

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 7.01 Regulation FD Disclosure.

On March 26, 2019, CareDx, Inc. (the “Company”) issued a press release regarding a patent infringement suit against filed against Natera, Inc. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The information in this Item 7.01, including the press release attached hereto as Exhibit 99.1, is intended to be furnished under Item 7.01 and Item 9.01 of Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
99.1	Press Release issued by CareDx, Inc., dated March 26, 2019.

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.

Date: March 26, 2019	CAREDX, INC.
	By:	/s/ Michael Bell
		Michael Bell
		Chief Financial Officer

EX-99.1

Exhibit 99.1

CareDx Files Patent Infringement Lawsuit Against Natera

CareDx protects innovation in transplantation by enforcing patent protection

BRISBANE, Calif., March 26, 2019 (GLOBE NEWSWIRE) — CareDx, Inc. (Nasdaq: CDNA), a leading molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients, today announced that it has filed a patent infringement suit against Natera, Inc., in the United States District Court for Delaware. CareDx is asserting U.S. Patent Nos. 9,845,497 and 8,703,652, that are exclusively licensed to CareDx from Stanford University. Stanford is joined in the suit as a necessary party because it is the registered owner of these patents. These patents cover non-invasive monitoring of organ transplant rejection through cell-free DNA analysis. CareDx is seeking all available remedies, including damages and injunctive relief. The suit asserts that Natera infringes through its marketing and performance of a test to analyze cell-free DNA from a transplant patient to inform rejection.

CareDx has been dedicated to continued research and development in transplantation for 20 years, and secured an exclusive license to the technology when it acquired ImmunMetrix in 2014.

“If intellectual property is disrespected, it is the transplant community that is impacted,” said Peter Maag, CEO of CareDx. “The intellectual property behind AlloSure was developed with substantial involvement from leading transplant researchers. We are filing this suit to support future innovation in transplantation. We will continue to monitor activities in the transplant field and vigorously defend our intellectual property where appropriate to protect our substantial investments and leadership position.”

About CareDx

CareDx, Inc., headquartered in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant recipients. CareDx offers products along the pre- and post-transplant testing continuum, and is the leading provider of genomics-based information for transplant patients.

For more information, please visit: www.CareDx.com.

CONTACTS:

Investor Relations

David Clair

Integrated Corporate Relations, Inc.

646-277-1266

david.clair@icrinc.com