Response Biomedical’s RAMP COVID-19 antigen test gets Health Canada approval.
Response Biomedical Corp. (Response), a global provider of acute care diagnostic testing solutions, is announcing today that Health Canada has granted the RAMP® COVID-19 Antigen Test authorization to commercialize under the Emergency Use Interim Order. The Health Canada authorization allows Response to market and sell the RAMP® COVID-19 Antigen Test to countries that recognize Health Canada authorization.
The RAMP® COVID-19 Antigen Test uses the RAMP® 200 instrument for the detection of SARS-CoV-2 nucleoproteins in nasal swabs from individuals who are suspected of having COVID-19 infection within the first 5 days of symptom onset. The results are delivered in 15 minutes, enabling timely decision-making for healthcare professionals and on-site identification of COVID-19. The test kit contains all required components, including the nasal swabs, to allow for the rapid triage of individuals suspected of SARS-CoV-2 infection.
The RAMP® instrument is a small, automated system capable of storing and transmitting results digitally. The RAMP 200 offers complete traceability and reportability with the flexibility of running one to six tests at a time.
“As a global provider of acute care tests, it was imperative for us to join the fight against the pandemic for Canada. The addition of the COVID-19 Antigen Test on our RAMP platform completes our panel of tests that have been used globally in the fight against COVID-19 since the start of the pandemic.” stated Dr. Barb Kinnaird, CEO of Response.
“At the onset of the pandemic, NGen mobilized funding to support made-in-Canada solutions to combat COVID-19,” said Jay Myers, CEO, NGen. “We are pleased to see that Response Biomedical’s RAMP COVID-19 antigen test has been recognized by Health Canada as a critical tool in our arsenal to protect the health and well-being of Canadians.”
Health Canada’s decision is under Health Canada’s expedited authorization pathway, Interim Order No. 3. As a part of the authorization process, clinical data gathered from prospective clinical studies were included in support of the RAMP COVID-19 Antigen test performance against recognized PCR lab-based tests. The test was developed with advisory support and research and development funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP).
About Response Biomedical Corporation
Response Biomedical Corp. (Response) is a Canadian manufacturer and global supplier of diagnostic tools that aid in the diagnosis of life-threatening diseases. Response focuses on providing lab quality results in minutes and our RAMP® technology delivers a total solution for making better, faster decisions. RAMP® tests are commercially available to aid in the diagnosis of heart attack, congestive heart failure, sepsis, pregnancy and more. The company is passionate about the patient’s experience and our core purpose to save lives globally. For more information about Response, visit www.responsebio.com.