The US Food and Drug Administration (FDA) has granted 510(k) approval for the Bladder EpiCheck test of liquid biopsy company Nucleix.
The test has been approved to be marketed as a non-invasive technique for monitoring the recurrence of tumours in patients who were earlier diagnosed with non-muscle invasive bladder cancer (NMIBC).
The approval allows the use of Bladder EpiCheck in combination with cystoscopy in the targeted patients.
The test is capable of evaluating subtle changes specific to the disease across 15 methylation markers that are linked to bladder cancer.
Currently commercially available in Europe, Bladder EpiCheck represents the first-of-its-kind urine biomarker methylation test carried out on a qPCR platform to receive clearance from the FDA.
Bladder cancer is estimated to be the sixth most common cancer in the US, with around 700,000 people being affected by the disease in the country.
The majority of those patients are categorised as NMIBC patients. NMIBC’s treatment involves both surgical and therapeutic methods.
Since the disease has a very high rate of recurrence, it needs to be monitored regularly to quickly detect high-grade recurrence and start treatment prior to its progression.
Nucleix Medical Affairs vice-president Aharona Shuali said: “Because surveillance of NMIBC remains one of the most invasive and lengthy processes to manage for patients across the oncology landscape, an objective, sensitive and specific urine-based test like Bladder EpiCheck is an important new tool that physicians can leverage in conjunction with the current standard of care.”
The company is currently exploring options to form strategic alliances and for other market access deals to commercially introduce Bladder EpiCheck in the US.