Liquid biopsy company Nucleix has been granted 510(k) clearance from the US Food and Drug Administration (FDA) to market its Bladder EpiCheck for non-muscle invasive bladder cancer (NMIBC) monitoring.
Bladder EpiCheck is now cleared for use as a non-invasive method to monitor the recurrence of tumours in patients with a past diagnosis of NMIBC, in combination with cystoscopy, a standard of care method.
Nucleix said that the test gives physicians and their patients a simple, objective urine test for recurrent bladder cancer.
The urine biomarker methylation test is designed to evaluate disease-specific variations in 15 methylation markers that are linked to bladder cancer.
Available commercially in Europe, the CE-marked Bladder EpiCheck is claimed as a highly sensitive and specific test.
According to Nucleix, it is the first of its kind methylation-based urine test cleared by the FDA for use on a quantitative polymerase chain reaction (qPCR) platform.
Nucleix president Eli Frydman said: “We are pleased with the FDA’s decision to grant Bladder EpiCheck 510(k) clearance, allowing the test to be commercialised in the United States.
“With this clearance, we look forward to offering physicians and their patients in the United States access to our reliable, objective and non-invasive 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.
“This clearance further validates Nucleix’s EpiCheck-based technology and our ability to provide physicians non-invasive diagnostic tools to enhance patient care.”
The liquid biopsy company is seeking partnerships and other market access initiatives for the commercial rollout of Bladder EpiCheck in the US.
Nucleix is engaged in the production of disease detection methods for cancer treatment. Its testing approach uses next-generation sequencing (NGS)-based and PCR-based technology to identify methylation changes.
The firm is also progressing its Lung EpiCheck test towards commercialisation for patients at high risk.
