ACT Genomics has devoted to precision medicine for years, besides providing cancer genomic profiling services, ACT Genomics cooperates with industry, government and academy proactively, focusing on innovative research and devleopment of cancer genomic profiling, which conforms to international starndards. By optimizing the management in sequencing and quality control, ACT Genomics ensures trusted test results. In May, 2020, ACT Genomics is the first laboratory registered in TW FDA's Laboratory Developed Tests and Services (LDTS).
What Is LDTS？
The spirit of precision medicine, or personalized medicine is to tailor disease prevention, diagnosis and treatment plan via understanding the makeup of genomics, living environment and life styles. Most of the precision medicine molecular testing are developed by individual laboratory, called Laboratory Developed Tests and Services (LDTS).
In recent years, the progress of molecular testing revitalizes the development of correlated industry and in order to ensure that Taiwan Precision Medicine laboratory can provide trusted result and increase competitiveness, TWFDA announced the LDTS for laboratories' registration.
LDTS Regulates Cancer Genomic Profiling For Safe Medical Use
LDTS combines "Laboratory Developed", "Precision Medicine"and "Molecular Diagnosis" concepts, according with regulations in US and European Union to provide concrete regulations, categorization method, quality certification and registration mechanism to genomic profiling for medical use. Laboratory needs to meet the demand of medical institute, provide sequencing method, original record and sequencing result to ensure the reliability, accuracy and reproducibility. In order to avoid unhealthy commercial behaviors from some genomic profiling companies to mislead people, LDTS will announce qualified laboratories in TWFDA website for people to search for, serving as an effective way to tell the difference of genomic profilings to avoid bad ones drive out good.
ACT Genomics' Clincial Cancer Genomics Profiling Is Recognized With Vision For Asian
ACT Genomics keeps up with the times in the precision medicine field, and acts in concert with the national medical policy and medical technology. In response to the rise of precision medicine, ACT Genomics is the first company receiving CAP, and grabs most of the attention for the outstanding performance. Nevertheless, to build the true foundation of Asian precision medicine, ACT Genomics sets up offices in several countries in Asia, and dedicated to spot Asian unique genes despite those generic ones already published, to carve the new way to a database tailored to Asian while integrating major international genomic databases along the way.
LDTS registration proves that ACT Genomics provides reliable clinical genomic profiling results with clinical value, by following national policy and cooperating with major pharma companies. This effort successfully allows many cancer patients to get better treatment opportunities through application for new targeted therapy and compassionate use. Any genomic profiling influencing treatment decisions needs to be verified many times for its quality assurance and ACT Genomics is committed to bring high quality, reliable clinical cancer genomic profiling which meets international and Taiwan regulatory and bring the best of genomic profiling to patients.