Dynamiker Receives Approval from the New York State Department of Health's Clinical Laboratory Evaluation Program

On July 21, 2025, Dynamiker's independently developed Fungal (1-3)-β-D Glucan Detection Kit (Chromogenic) (G Test) and Aspergillus Galactomannan Detection Kit (Enzyme-Linked Immunoassay) (GM Test) were successfully approved by the New York State Clinical Laboratory Evaluation Program (NYS CLEP). Both kits received Laboratory Developed Test (LDT) approval. This recognition demonstrates that Dynamiker's technological leadership in diagnosing invasive fungal diseases has been acknowledged by the relevant authorities in New York State, marking a milestone in the development of Dana Biotech's precision fungal disease diagnostic products for international strategic markets.

The New York State Department of Health's Clinical Laboratory Evaluation Program (CLEP) has a rigorous laboratory-developed test (LDT) review process and standards. It oversees and supervises clinical diagnostic laboratories that test biological specimens from New York State residents. Its goal is to ensure the accuracy and reliability of test results from clinical laboratories located within the state or from New York State residents. LDT approval is a testament to the strength of Dana Bio's products under stringent standards. The two approved products, the G test and the GM test, can test serum, bronchoalveolar lavage fluid (BALF), and cerebrospinal fluid (CSF) samples. These expanded sample types better meet local needs.

Dynamiker continues to innovate and develop in vitro diagnostics for fungal diseases, actively expanding into overseas markets through a global approach. It has obtained 102 EU CE certifications, has applied for IVDR certification with an EU Notified Body, and has initiated US FDA 510(k) approval. The company aims to provide comprehensive solutions to the global challenges of fungal diseases and antifungal resistance.