Sam Brusco, Associate Editor05.05.23
Nucleix, a liquid biopsy company, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Bladder EpiCheck as a non-invasive method to surveil tumor recurrence in patients previously diagnosed with nun-muscle invasive bladder cancer (NMIBC), in conjunction with cystoscopy.
According to the company, Bladder EpiCheck it a sensitive, specific test to analyze subtle, disease-specific changes across 15 methylation markers associated with bladder cancer. The test is already commercially available in Europe.
NMIBC requires frequent surveillance to promptly detect high-grade recurrence and treat it before it progresses and becomes life-threatening. The standard of care involves frequent and invasive cystoscopies that patients endure up to four times a year for at least five years and, in some cases, the remainder of their life.
“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,” Aharona Shuali, MD, VP of Medical Affairs at Nucleix told the press.
“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,” said Eli Frydman, Ph.D., president at Nucleix. “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.”
According to the company, Bladder EpiCheck it a sensitive, specific test to analyze subtle, disease-specific changes across 15 methylation markers associated with bladder cancer. The test is already commercially available in Europe.
NMIBC requires frequent surveillance to promptly detect high-grade recurrence and treat it before it progresses and becomes life-threatening. The standard of care involves frequent and invasive cystoscopies that patients endure up to four times a year for at least five years and, in some cases, the remainder of their life.
“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,” Aharona Shuali, MD, VP of Medical Affairs at Nucleix told the press.
“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,” said Eli Frydman, Ph.D., president at Nucleix. “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.”