UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
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Item 8.01. Other Events.
On January 9, 2025, Interpace Biosciences, Inc. (the “Company”) issued a press release announcing that Interpace Diagnostics, LLC, a subsidiary of the Company, responded to the final Local Coverage Determination (“LCD”) of Genetic Testing for Oncology (L39365) issued by the Centers for Medicare & Medicaid Services. The new LCD establishes non-coverage for the Company’s PancraGEN® test, a molecular diagnostic test that assesses pancreatic cyst cancer risk (“PancraGEN”).
Because PancraGEN is primarily ordered for Medicare patients, the Company will no longer be offering its PancraGEN test. Specimens for first-line fluid chemistry and PancraGEN testing will not be accepted after February 7, 2025 as a result of the new LCD.
A copy of the press release is filed as Exhibit 99.1 hereto and incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
The following exhibits are being filed herewith:
| Exhibit No. | Description | |
| 99.1 | Press Release dated January 9, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURE
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.
| Interpace Biosciences, Inc. | ||
| By: | /s/ Thomas W. Burnell | |
| Name: | Thomas W. Burnell | |
| Title: | President and Chief Executive Officer | |
Date: January 10, 2025