Camtech and JN Medsys Ramp Up Production of Health Sciences Authority-Approved COVID-19 PCR and Rapid Test Kits
Complementary solutions to boost global COVID-19 testing capabilities
Singapore, 14 April 2020 – Two Singapore firms, Camtech Diagnostics Pte. Ltd. (“Camtech Diagnostics”) and JN Medsys Pte. Ltd. (“JN Medsys”), have obtained provisional authorisation from the Health Sciences Authority (“HSA”), the Singapore authority regulating health products, for two COVID-19 test kits. Camtech Diagnostics is the research and product development arm of Camtech Holdings Pte. Ltd. (“Camtech”), a local technology company. Camtech is also an investor in JN Medsys, a local life science firm.
Camtech Diagnostics’ COVID-19 IgG/IgM Rapid Qualitative Screening Test” (“Rapid Test”) detects for the antibodies immunoglobulin M (lgM) and immunoglobulin G (IgG) in serum, plasma and whole blood of those infected with COVID-19. The test provides results in 10 minutes without specialised equipment or laboratory-trained personnel. This makes it a quick and easy tool for assisting in the screening and identification of asymptomatic carriers during this COVID-19 outbreak, although it should not be used for confirmatory testing, or as the sole basis of a diagnosis. The company is also carrying out further development to enable more sensitive detection at an earlier point post-infection than current IgM/IgG tests.
JN Medsys’ test kit, the ProTect™ COVID-19 RT-qPCR Kit” (“PCR Kit”), is a nucleic acid test that detects for the virus that causes COVID-19. The PCR Kit identifies the genetic material of the SARS-CoV-2 virus isolated from infected patient samples using the reverse transcription quantitative polymerase chain reaction (“RT-PCR”) method. It utilises the United States (“US”) Centers for Disease Control and Prevention protocol, detecting three targets on the virus genes to test for COVID-19 infection. The RT-PCR method is known as the gold standard method for its high sensitivity and specificity to identify the virus even at low copies. The test results can be obtained within two hours, with an accuracy of more than 95 per cent.
In addition to HSA’s provisional license, JN Medsys has obtained approval for the PCR Kit from the Food and Drug Administration (“FDA”) of the Philippines, and is in the process of obtaining approval from the US FDA. The PCR kits have been clinically validated in Singapore and abroad.
Camtech Diagnostics and JN Medsys had previously received Spring Singapore innovation grant funding as well as private investment from local angel investors.
Dr Kuok Meng-Han, Founder and Managing Director of Camtech, said, “The current COVID-19 pandemic has resulted in the urgent requirement of various countries globally for diagnostic tests to identify the presence of the virus and antibodies in the blood. Our complementary test kits cover the spectrum from accurate lab-based methods to rapid, point-of-care tests, crucial to helping control and contain the spread of the disease.”
He added, “We are now planning to expand manufacturing in Singapore for both kits in order to meet the projected demand. Our background in developing high-end molecular and point-of-care diagnostic tests enabled us to use these platforms to rapidly develop and supply COVID-19 tests. On a broader note, the fast turnaround to develop these kits is also testament to Singapore’s long term investment in life science capabilities, which has built up a vibrant ecosystem of private and public labs as well as biotechnology companies that can quickly develop products which are critical during this time of need.”
Dr Johnson Ng, Chief Executive Officer of JN Medsys, said, “Digital PCR is already a core product for our existing business, and we have now extended our business line to PCR Kits to cater to worldwide demand. Our familiarity with manufacturing and distributing high quality PCR-related instruments and kits allows us to get these test kits quickly to the hospitals and labs, where accurate and affordable testing is so crucial for the containment of the COVID-19 outbreak. We have deployed these PCR Kits to China, Malaysia and Indonesia, and will be distributing them to ASEAN, Europe and South America soon.”
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