Gene on Link LLC, has received Clinical Laboratory Improvement Amendments (CLIA) certification from the Centers for Medicare & Medicaid Services (CMS). This certification enables the laboratory to perform high-complexity testing, ensuring that the lab’s test reports and results are recognized by U.S. healthcare and regulatory agencies, including CMS and the FDA.
With this CLIA certification, Gene on Link LLC will play a strategic role in Kimforest’s expansion into the U.S. precision medicine market. CLIA certification allows the company to expedite clinical trials for its genetic testing products directly in-house, thereby reducing reliance on third parties and maintaining greater control over the regulatory approval timeline. Gene on Link LLC will provide comprehensive testing services to support the company’s genetic testing product line expansion into the U.S. market.
In parallel, Kimforest’s Taiwan-based laboratory has applied for the prestigious international CAP (College of American Pathologists) certification. With CAP certification, the lab will meet rigorous standards on par with U.S. clinical laboratories, facilitating entry into global clinical testing markets. Kimforest has already established partnerships with several California-based medical institutions, and clinical testing and reporting services are expected to commence shortly. The company is actively expanding collaborations with U.S. healthcare institutions and initiating discussions with major insurers to ensure that tests conducted by Gene on Link LLC are covered by insurance.
Gene on Link LLC can also conduct clinical trials on U.S. specimens to support Kimforest’s products requiring FDA 510(k) clearance, such as its GOL genetic testing and cancer gene testing products. Additionally, Gene on Link LLC is facilitating the clinical trials and data production for Kimforest’s new COVID-19 rapid extraction test kit. This innovative test reduces testing time, offering a cost-effective alternative to current testing products. Once FDA Emergency Use Authorization (EUA) is granted, the COVID-19 rapid extraction kit is expected to gain a competitive market edge, potentially surpassing current product sale
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