HONG KONG SAR - Media OutReach - 15 July 2021 -ACT Genomics Holdings Co. Ltd.("ACT Genomics" or "the Group") announced today that its NGS testing-focused operation and laboratory at the Hong Kong Science Park has been accredited by the Accreditation Committee of the College of American Pathologists (CAP). With two already CAP accredited laboratories in Taipei and Kanagawa, Japan, and now the latest addition, the Group has notably strengthened NGS testing services and R&D capacity.
The CAP accredited ACT Genomics HK Laboratory, which started operation at the Hong Kong Science Park in July, 2019, made it through stringent CAP tests in the accreditation process. And, external quality assurance tests will be conducted twice a year hereafter to ensure the laboratory meets required standards at all times.
The laboratory has a dual NGS testing platform from Illumina and Thermo Fisher. Spanning 3,500 square feet, it is run by a team of eight qualified laboratory technicians, including one PhD, three with master's degree, and four registered Medical Laboratory Technologists. The newly accredited laboratory can play a major supportive role in the region.
Apart from boosting the capacity of the Group for providing services and support, the three laboratories will continue to pursue research projects, helping develop new products to enrich the Group's product portfolio and enable it to seize other business opportunities.
According to the facility'sDirector Alfa Bai, PhD (Dr. rer. nat.), the accreditation is substantive, in the 18-month accreditation process, on top of on-site visit to the laboratory, CAP also assigned tests to the team – altogether 20 external quality assurance reference samples and over a thousand achieved research samples for testing at the laboratory – to confirm the accuracy and consistency of its work.
Bai says the CAP accreditation process is more stringent than the others of its kind, requiring not only very high management standard, but also meticulous technical and operational details. Though there had been a delay because of the Covid-19 pandemic, the accreditation came within two years the laboratory opened. In the past, samples of Hong Kong patients were sent to the Taipei laboratory for testing, and now the results could be known sooner. The Taipei laboratory will have a lighter load and for the Group, it will have a bigger capacity to serve cancer patients in the region.
Hua Chien Chen, PhD, Chief Executive Officer of ACT Genomics Holdings Co. Ltd. says, "Our laboratory in Hong Kong is fully functional for NGS testing. Although it is not required by law to obtain international accreditation to conduct clinical tests for patients, ACT Genomics is determined to seek the CAP recognition that it may ensure the laboratory maintains the highest professional standards. With our three laboratories in full-swing, we can serve more patients and are well-backed up in delivering professional and timely services. We will also be able to collect more cancer-related data of Asians to add to the data we have collected over the years, to the benefit of R&D of cancer treatment."
The CAP Laboratory Accreditation Program, recognized by the U.S. federal government, was launched in the early 1960s, as being equal-to or more-stringent-than government inspection programs.
The CAP accreditation process is designed to ensure a laboratory affords the highest standard of care for all patients it serves. Inspectors from CAP examine a laboratory's records and quality control of procedures in the preceding two years, and laboratory staff qualifications, equipment, facilities, safety program and record, and overall management audits are carried out on an ongoing basis.
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About ACT Genomics Holdings Co. Ltd.
ACT Genomics® is an innovation-driven cancer solution provider in Asia with offices in Taipei, Hong Kong, Singapore and Tokyo. After setting up our laboratories in Taiwan and Japan, we opened our third laboratory in Asia at Hong Kong Science Park in July 2019. With our Next-Generation Sequencing (NGS) technology, CAP-accredited laboratories, experienced bioinformatics team and proprietary AI algorithms, we provide optimal cancer treatment planning, immunotherapy evaluation, cancer relapse & drug resistance monitoring, as well as cancer risk assessment services to medical professionals.
Our team is specialized in biomarker identification, underlying disease mechanism discovery and genetic alteration exploration. Pharmaceutical communities are also able to benefit from our expertise in identifying targets for drug development, stratifying patients for clinical studies, and delineating drug responses with efficiency and efficacy. We also participate in various international precision medicine biomarker programs, such as the TMB and HRD Harmonization Programs led by FOCR in the United States. Together, we "Turn Genomics into Action".
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