JN Medsys receives Singapore Health Sciences Authority provisional authorisation for its ProTect Covid-19 PCR kit
JN Medsys announces today that its ProTect Covid-19 kit has received provisional authorisation from Singapore’s Health Sciences Authority (HSA) for in-vitro diagnostic use. The ProTect kit is a nucleic acid test that detects for the virus that causes COVID-19. It identifies the genetic material of the SARS-CoV-2 virus isolated from infected patient samples using the reverse transcription quantitative polymerase chain reaction method. Developed in accordance with the United State’s Communicable Disease Center (CDC) protocol, it provides for a sensitive and accurate method for confirmatory detection of the Sars-CoV-2 virus.
JN Medsys is a Singapore company that manufactures PCR instruments and related products Its main product is the Clarity digital PCR system along with its associated consumables and assay kits. It developed the ProTect kit in response to demand for the Sars-CoV-2 testing as the outbreak spread rapidly in China and some parts of Asia. It also has a version of the Covid-19 kit that works on the Clarity digital PCR system, which can provide absolute quantification of the Sars-CoV-2 virus.
“Our main business is in digital PCR, but we developed the ProTect real-time PCR kit in response to strong demand for test kits when the outbreak was still concentrated within China. Now that the outbreak has spread very rapidly across the world, we see an exploding demand for the kits. To contain the disease, accurate and early diagnostics is critical. With HSA’s provisional approval, this will help to expedite users’ access to the kits. We are grateful to HSA for working very closely with us to expedite this provisional approval. As a company, we are thankful to be able to contribute to society during this time of need”, says Johnson Ng, CEO of JN Medsys.
The company is exploring getting regulatory approvals for the kit in Europe and elsewhere in order to make them more accessible to laboratories in these regions