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Nucleix Bladder EpiCheck Cancer Liquid Biopsy Test Gets FDA 510(k) Clearance

NEW YORK – Liquid biopsy company Nucleix said on Thursday that its Bladder EpiCheck cancer recurrence test has received 510(k) clearance from the US Food and Drug Administration.

The FDA decision authorizes the test, which analyzes disease-specific changes in 15 DNA methylation markers in urine using qPCR, for use in monitoring patients diagnosed with non-muscle invasive bladder cancer (NMIBC), in conjunction with cystoscopy.

Nucleix, which has operations in San Diego and in Rehovot, Israel, is currently evaluating strategic partnerships and other market access activities related to commercially launching the test in the US.

Bladder EpiCheck is CE-marked and currently available in Europe, where its label was expanded last year beyond recurrence testing to aid in detecting primary bladder cancer and upper tract urothelial carcinoma in patients presenting with hematuria, other urinary tract symptoms, or findings indicating malignancy.

"We are pleased with the FDA’s decision to grant Bladder EpiCheck 510(k) clearance, allowing the test to be commercialized in the United States," Eli Frydman, president of Nucleix, said in a statement. "With this clearance, we look forward to offering physicians and their patients in the United States access to our reliable, objective, and noninvasive bladder cancer test that can be performed at any licensed central or local labs, thus providing healthcare professionals the flexibility to run the test where it is needed."