DiSa receives quality certification mark for saliva-based Covid-19 ART kits

HEALTHCARE digitalisation company DiSa : 532 0% has been awarded CE-IVD (In-Vitro Diagnostic) mark for its Pasport Gold Sars-CoV-2 ART kit under the IVD Directive (98/79/EC) on May 19.

In a bourse filing on Tuesday (May 24), the group said this quality certification mark allows the wholly-owned subsidiary of its Digital Life Line (DLL) business to potentially commercialise the ART kits legally in the European Union (EU).

DLL is also in the midst of conducting a clinical validation study to seek approval from the Health Sciences Authority of Singapore, as well as attain ISO certification for its Pasport ART kit.

“Receiving the CE-IVD mark is a major commercialisation milestone for DLL and with that we are looking to launch the Pasport ART kit in the EU in the third quarter of this year”, said managing director and chief executive of DiSa, Eddie Chng.

According to the group, the test results will be “impossible” to tamper with, as DiSa Serialization technology is used to tag the ART kits for tracking and tracing purposes.

This will allow the ART kit to overcome the reliability issues with saliva-based testing, and make testing more affordable and convenient by allowing for wider adoption, added Chng.

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“We are proud to deploy this unique technology, developed in Singapore that can track existing and future variants and does not require additional equipment or skilled personnel for the testing process”, said Soo Khee Chee, who is chairman of DLL’s board and also inaugural Benjamin Sheares professor in academic medicine at Duke-NUS Medical School.

DiSa was trading flat at S$0.004 as at 1.12pm, after the announcement was made.