Allarity Therapeutics, Inc. (NASDAQ: ALLR) announced it has obtained a Certificate of Registration under the Clinical Laboratory Improvement Amendments (CLIA) for its in-house laboratory in Horsholm, Denmark.

The certification, administered by the U.S. Centers for Medicare & Medicaid Services, allows Allarity to perform its Drug Response Predictor (DRP®) biomarker testing internally rather than relying on external partner laboratories. The FDA requires that biomarker testing used to select patients for registration trials be conducted in a CLIA-certified laboratory environment.

According to the company's press release, the in-house capability is intended to support the development of stenoparib, its dual PARP and WNT pathway inhibitor, toward a potential pivotal registration trial in advanced, platinum-resistant or platinum-ineligible ovarian cancer. Allarity said the move is expected to reduce turnaround times for DRP® analyses and lower long-term costs.

The company also stated that its Allarity Therapeutics Medical Laboratory will now be available as a CLIA-certified testing partner for European biopharmaceutical companies seeking to conduct clinical trials or commercialize products in the U.S. market.

"Achieving CLIA certification for our own lab is transformative, allowing us to bring DRP testing under our direct control for both clinical and commercial use in the U.S.," said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics.

Allarity is currently enrolling patients in a Phase 2 trial of stenoparib in platinum-resistant ovarian cancer, which began in summer 2025. A separate Phase 2 trial evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer began enrolling patients in early 2026 across multiple VA sites in the U.S.