Dow Biomedica said Monday that it received insurance coverage for Neolisa Chromogranin A test, a method that detects chromogranin A, which labels neuroendocrine tumors, from the Ministry of Health and Welfare on May 1.
International guidelines from Europe, the United Kingdom, Ireland, North America, Australia and the U.S. recommend Chromogranin A as a neuroendocrine tumor marker. In Korea, the ministry labeled the technology as “new health technology,” after confirming the safety and efficacy of the test in diagnosis, treatment monitoring, and progress in patients with suspected or confirmed neuroendocrine tumors.
According to the ministry’s notice, Neolisa, developed by Euro Diagnotica and sold exclusively by Dow Biomedica in Korea, is now subject to reimbursement if a malignant tumor is found or suspected in the primary organs.
The examination allows a 90 percent positive predictive value of tumor detection and can detect all types of neuroendocrine tumors, including those not observed in primary organs, at high levels. The minimum detection limit is as low as 19.2 ng/mL, with accuracy as high as at 360,000 ng/mL. The clinical sensitivity is 79.9 percent, and the clinical specificity is 97.7 percent. The test also gives less burdens to patients with more straightforward blood tests and quick results.
“Like other diseases, early diagnosis is important for carcinoid, classified as neuroendocrine tumors by the World Health Organization in 2010,” a company official said. “This is because the treatment becomes more difficult as the disease progresses.”