Asia’s integrated healthcare company, Clearbridge Health Limited (“Clearbridge” or the “Company” and together with its subsidiaries, the “Group”), is pleased to announce that Labnovation Technologies, Inc.’s (“Labnovation”) COVID-19 Antigen Rapid (“ART”) Test Kit, which is imported by Clearbridge and registered for use in the Philippines, has been recently approved by the Food and Drug Administration (“FDA”) of the Philippines for self-testing.
– The Group is currently the only approved importer of Labnovation’s COVID-19 ART Test Kit in the Philippines as the Group has submitted and obtained the relevant regulatory approval for the ART Test Kit to be imported and used in the country
– There are currently only two COVID-19 ART Test Kits, one by Labnovation and the other by Abbott Panbio, that have been recently approved by the FDA of the Philippines for self-testing
– Potential for the Group to work with various channel partners and point-of-care networks (such as clinics and pharmacies) in the Philippines to market and distribute Labnovation’s COVID-19 ART Test Kit across the country
– The Philippines has a population of approximately 110 million and according to the WHO, there are currently more than 3.4 million confirmed COVID-19 cases in the Philippines(1)
On 24 January 2022, the FDA of the Philippines approved two self-administered COVID-19 ART Test Kits, one from Labnovation and one from Abott Panbio, in compliance with the application requirements listed in the FDA Advisory No. 2021-0684 entitled “Guidance on the Process for the Issuance of Special Certification for COVID-19 Test Kits Based on FDA Memorandum No. 2020-006 and FDA Memorandum No. 2021-009.” These kits can be used by individuals to detect SARS-CoV-2 antigen from nasal swabs of probable COVID-19 patients(2).
To ensure safety, efficacy and quality of these COVID-19 test kits, the FDA of the Philippines also advised the public and stakeholders to source for the COVID-19 test kits from FDA authorized importers including the Group who are holders of the Certification for the COVID-19 test kits or their duly authorized FDA licensed distributors.
The Group is currently the only importer and distributor of Labnovation’s COVID-19 ART Test Kit in the Philippines as the Group has submitted and obtained the relevant regulatory approval for the ART Test Kit to be used in the country.
As a pan-Asian private healthcare group, Clearbridge has built up a business presence and network across regional markets. With deep experience and familiarity working with health authorities, medical supply chain logistic partners and healthcare institutions, the Group has established a procurement and distribution platform that offers a wide range of healthcare products, which includes the Sinopharm COVID-19 vaccine, COVID-19 ART Test Kit, COVID-19 Antibody Test Kit, among others, in Singapore and other countries in the region.
Mr. Jeremy Yee, Executive Director and Chief Executive Officer of Clearbridge, said, “In the Philippines, daily cases hit record highs in January following the detection of local cases of the Omicron variant.
COVID-19 self-testing is one of the key risk-reduction measures that protect communities and we have seen self-testing becoming a vital part of the pandemic response in various countries.
With the approval of Labnovation’s COVID-19 ART Test Kit for self-testing in the Philippines, we believe that it can serve as an important tool for routine testing by the public, offering some peace of mind at the same time.
We aim to work with various channel partners and point-of-care networks (such as clinics and pharmacies) in the Philippines for Labnovation’s COVID-19 ART Test Kit to gain wider market outreach and accessibility.”