The Ministry of Health and Welfare's National Health Insurance Administration recently announced that next-generation sequencing (NGS) testing will be included in health insurance coverage starting May 1st, with a total reimbursement of approximately 300 million NT dollars in the first year. The administration stated that for solid tumors, a total of 9 major cancer types can benefit from NGS to assist in selecting appropriate targeted drugs, while for hematologic malignancies, there are 3 cancer types eligible for NGS, with reimbursement being provided through a combination of fixed health insurance payments and out-of-pocket payments by individuals. Solid tumors covered by NGS include non-small cell lung cancer, triple-negative breast cancer, ovarian cancer/fallopian tube cancer/primary peritoneal cancer, prostate cancer, pancreatic cancer, NTRK gene fusion solid tumors, intrahepatic cholangiocarcinoma, thyroid cancer, and medullary thyroid carcinoma; hematologic malignancies include acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (MDS), acute lymphoblastic leukemia (B-ALL and T-ALL).
As the units performing NGS testing must be "regional or higher-level hospitals" or "hospitals certified for cancer treatment quality," and must be eligible to conduct testing by developing laboratory-developed tests (LDTs) approved by the Ministry of Health and Welfare, a total of 12 laboratories have currently passed the review process. Leading laboratories such as Genetics Generation Advancement Corp, Sofiva Genomics, and Kim Forest Enterprise all have Ministry of Health and Welfare-certified LDTs laboratories, while TSH Biopharm is currently undergoing Ministry of Health and Welfare review.
Sofiva Genomics is actively developing cancer genetic screening. Last year, it introduced the latest fully automated NGS instrument from Roche Diagnostics, streamlining over 100 operational steps, reducing manpower burden, and assisting in improving the accuracy of subsequent next-generation sequencing tests. It is expected that starting this year, the NGS business will experience significant growth. TSH Biopharm has also introduced NGS testing services, with the potential to challenge 50% of the total market share for organization-wide testing in Taiwan, with an estimated health insurance market share of over 5%. KIM Forest has collaborated with more than 30 hospitals domestically, focusing on testing opportunities for various mutated genes in colorectal cancer, breast cancer, lung cancer, and more.
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