Calmark is developing a POC-test to help assess disease severity for patients with COVID-19 patients
The Board of Directors of Calmark Sweden AB has today resolved to prioritize the development of a diagnostic point-of-care (POC) test for the lactate dehydrogenase biomarker (LDH) aimed at adult patients with COVID-19. Several studies have demonstrated that LDH levels can predict the severity and mortality of the disease. Since the time aspect of COVID-19 products is of paramount importance, this test will be developed in parallel with the tests for newborns; Neo-LDH and Neo-Glucose.
In the ongoing COVID-19 coronavirus disease pandemic, more than 9 million cases of infection have been confirmed worldwide. The condition is associated with high morbidity and a high fatality rate, leading to significant strain on the healthcare system. It would thus be helpful to be able to, in an earlier stage, identify patients who risk becoming seriously ill and in need of intensive care, in contrast to those who become more mildly ill.
The lactate dehydrogenase (LDH) biomarker has been shown in several studies to be helpful in determining prognosis in patients with COVID-19. Studies that have been published for example in the renowned medical journal "The Lancet" have suggested significant differences in LDH levels between patients with severe disease and patients with less severe outcome. In the American Journal of Emergency Medicine, nine research studies are compiled showing:“Elevated LDH levels were associated with a ~6-fold increase in odds of developing severe disease and a ~16-fold increase in odds of mortality in patients with COVID-19.”1
Calmark is already today developing a test for LDH that can detect oxygen deficiency during childbirth. By changing the measurement range, a test to assess the severity of COVID-19 can be developed on the same platform. All assurances for the CE marking of this product can be carried out in Calmark's laboratory. In addition, many countries have introduced a simplified registration process for products associated with the pandemic. These two factors contribute to the opportunity for faster market launch.
"We have carried out research on LDH for 13 years, and our development of an LDH test for newborn infants is at a very advanced stage. Calmark has a unique position to be able to develop an LDH test for triage of COVID-19 patients,” says Anna Söderlund, CEO of Calmark. “A test for assessing COVID-19 could facilitate for the healthcare sector if the pandemic continues. In parallel with the development of the LDH test for newborns, we are now also developing this test for adults."
This information is information that Calmark Sweden AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, at 23:45 CEST on 25 June 2020.
Every care has been taken in the translation of this document. In the event of discrepancies, the Swedish original will supersede the English translation.
1 B.M. Henry, G. Aggarwal, J. Wong, et al., “Lactate dehydrogenase levels predict coronavirus disease 2019 (COVID-19) severity and mortality: A pooled analysis”, American Journal of Emergency Medicine (2020), https://doi.org/10.1016/j.ajem.2020.05.073
For more information about Calmark Sweden AB, please contact:
Anna Söderlund, CEO
Telefon: +46 70 214 98 93
Calmark Sweden AB is a medical technology company developing a point-of-care (POC) analysis method with easier and faster diagnostics of medical conditions in newborns. The unique test platform consists of a reader and single-use products. The first three tests are being launched in 2020. WHO expects 1.5 billion children to be born worldwide prior to 2030. In the Western world, the introduction of POC diagnostics is resulting in huge savings and shorter care chains. In less developed healthcare systems, the product will offer decision-making support, which is currently lacking, since the access to hospital laboratories often is limited. Calmark aims to become the global leader in POC diagnostics for newborns and, in the long term, to offer all relevant tests for the first period of life. The B share is listed on the Spotlight Stock Market and is traded under the CALMA B ticker. Read more at www.calmark.se/eng/home.