Milestones

Spun off from the Industrial Technology Research Institute (ITRI)

Successfully closed Series A financing

Established global core patent portfolio

Achieved ISO 17025 accreditation for testing laboratories

Launched DNlite laboratory testing services

Secured a contract with European pharmaceutical leader Boehringer Ingelheim to provide global clinical trial testing services

Presented Boehringer Ingelheim’s global clinical trial results at the American Society of Nephrology (ASN)

Relocated to Tai Yuen Hi-Tech Industrial Park and established a GMP-certified manufacturing facility

Selected as the "R&D Benchmark Biotech Company" at BioTaiwan Highlights 2017​

Successfully finalized the development of the DNlite In Vitro Diagnostic (IVD) assay

Completed Series A Extension financing round

Completed the IVD GMP manufacturing facility and secured the official factory registration certificate

Obtained regulatory licenses for both medical device manufacturing and distribution

Commenced pilot production of the DNlite IVD assay

Achieved ISO 13485:2016 Quality Management System (QMS) certification for the design and manufacture of ELISA assays

Executed treasury stock cancellation for capital reduction and issued new shares for employee stock options (ESOP) to increase capital

Successfully passed TFDA GMP inspection and secured the certification

Secured EU CE IVD marking for DNlite, authorizing market entry within the European Union

Obtained regulatory approval from the Medical Device Authority (MDA) of Malaysia for DNlite

Officially registered for Public Offering (Stock Code: 6810)

Signed a distribution agreement with a Malaysian distributor

Acquired the previously leased manufacturing facility and office space

Completed European clinical studies on the prognosis of Diabetic Kidney Disease (DKD) and kidney transplantation (KT)

Obtained regulatory approvals for DNlite in Thailand and Saudi Arabia, further expanding our global market footprint.

Secured market approval for DNlite-DKD from the Taiwan Food and Drug Administration (TFDA).

Secured market authorizations for DNlite-DKD in the UAE, Vietnam, Indonesia, Brazil, and Singapore, significantly expanding our footprint across high-growth global markets.

Obtained regulatory approvals for DNlite-DKD & KT in Guatemala and Australia, and successfully achieved EU IVDR certification.

Signed a strategic technical licensing agreement with Boditech Med Inc.

Obtained regulatory approvals for DNlite in Turkey, Mexico, and Malaysia, further solidifying our market leadership across Eurasia and Latin America.

Officially incorporated into the 2024 Taiwan Clinical Practice Guideline for Diabetic Kidney Disease, establishing DNlite as a standard-of-care tool for precision renal risk assessment.

Honored with the 2025 National Pharmaceutical Technology & Research Development Award (NPRDA) and the National Innovation Award (Corporate Innovation category), recognizing our excellence in clinical R&D and translational medicine.