ACT Genomics Hong Kong Laboratory Earns CAP Accreditation NGS Testing and R&D Capacity Strengthened

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’s Director 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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