“Our product development in 2018 went better than we planned thanks to an incredibly well-done job from everyone at Calmark. We therefore see an opportunity to launch our first product up to six months earlier,” says Mathias Karlsson, founder and chairman of Calmark.
The bilirubin test, which is used to diagnose jaundice (icterus), is the product that Calmark estimates to have the greatest market potential. Prioritizing the bilirubin test means that the launch of Calmark's first product can take place earlier and that registration of permits in countries outside the EU can start earlier. Each test is CE marked separately together with the reader and launched as a separate product. The original plan was to launch the first three tests simultaneously. Today's decision means that Calmark's readers can enter the market faster and then be supplemented with several POC tests. The schedule for the CE marking of the tests for LDH and glucose remains and the launch of these will take place early in 2020.
“We see many advantages with today's decision to divide the project into separate launches,” says Anna Söderlund, CEO at Calmark. "The clinical tests will focus on one marker at a time and we utilize resources optimally, the CE marking process is speeded up and we can take market shares earlier than planned!"
The bilirubin level in the blood is the most common blood test taken on newborns. Calmark's estimate is that more than 20% of newborns have a clinical need of a fbilirubin test. By the year 2030 about 1.5 billion children will be born according to WHO. The research shows that the introduction of point-of-care diagnostics leads to the total cost of care being reduced by about 8-25% *.
* Schilling UM. The economic benefits of point-of-care testing. Hospital Healthcare Europe, special supplement. www.hospitalhealthcare.com.