Key Alliance obtains first stage approval to sell PCR Covid-19 test kits

PETALING JAYA: Key Alliance Group Bhd’s wholly owned subsidiary Key Alliance Sdn Bhd (KASB) has been issued the Good Distribution Practice for Medical Devices Certificate of Conformity, which allows KASB to act as a local authorised representative for the import, storage and handling, warehousing and documentation of medical devices, specifically in vitro diagnostic devices.

Key Alliance said it today received notification from Conformity Assessment Bodies Malaysia, an approved certification body by the Medical Devices Authority (MDA) which is part of the Health Ministry, that KASB has passed the initial audit.

“This is the first step in order for the company to be able to be legally allowed to market, distribute and sell the Care Gene Covid-19 PCR test kits manufactured by Wells Bio Inc, Korea. IDTF Inc and Wells Bio will immediately begin negotiations with Key Alliance to solidify the distribution agreement with further commercial and exclusivity details,“ Key Alliance said in a statement today.

The next immediate step is for KASB to submit for the MDA Establishment License which will ensure that the company is in full compliance with the Health Ministry and the MDA’s requirements for a company to be a licensed distributor of medical supplies.

Consecutively and immediately after, KASB will submit its product of the Care Gene Covid-19 PCR test kit to the MDA for special access approval, which will then allow this test kit to be legally marketed and sold in Malaysia.

With the second wave of Covid-19 infections already spreading in Beijing, where over 1,500 flights were grounded on June 18, 2020, there is a foreseeable need for regular stockpiles of PCR test kits, which the Malaysian government has deemed to be the preferred testing method, as opposed to antibody or antigen rapid test kits.

Early detection plays a key role in treating Covid-19 patients. The real time RT-PCR technique is a highly sensitive and specific testing method that can deliver a reliable diagnosis in as fast as three hours, unlike the other laboratory tests that take an average of six to eight hours. Real time RT-PCR is significantly faster and has a lower potential for contamination or errors as the entire process is within a closed tube. Therefore, currently it is considered to be the most accurate method available for detection of the coronavirus. This has created huge demand for PCR testing kits.

The Wells Bio Inc CareGene PCR test kit also has an accelerated reaction time of 83 minutes, which improves laboratory efficiency and allows the increase quantum of testability amongst the population.

With the advent of social distancing and the new norm, digital healthcare, high grade diagnostic equipment and big data mining are tremendous growth potentials and the group will seek to be an immediate participant in this sector.

“The group, with its data centre and cloud services already in place, is well positioned to segue into the digital healthcare industry. With the MDA licenses to be issued, the entire ecosystem of diagnostics, medical supplies and digital healthcare services will be the group’s focus to ensure its relevance and growth.

“The group has already begun exploring the synergies of having a medical sciences portfolio, with digital healthcare and medical device distribution being a potentially lucrative revenue spinoff,“ it said.

Synergies between cloud services, application development and testing results to be archived represents a new silo of operations that the group is diverting its immediate attention to.

source https://www.thesundaily.my/business/key-alliance-obtains-first-stage-approval-to-sell-pcr-covid-19-test-kits-NM2608582