Clinical trial at Södersjukhuset begins – the last step in the CE mark process
Today, Calmark Sweden AB announces the start of the clinical trial to support the CE Mark approval of the company’s bilirubin test. The trial is commencing in cooperation with the research entity of the children's hospital Sachsska barn- och ungdomssjukhuset, a part of Södersjukhuset. The trial has been approved by the hospital’s legal department, which means that it formally can be launched. The trial is expected to be finished before the end of the year.
The trial is designed as a method-comparison study, where bilirubin analyzed with Calmark Neo is compared with the hospital laboratory’s analytical results. The latter is used as the reference method in the comparison. The trial includes 40 newborn infants.
“I am thrilled that we now have received the approval from Södersjukhuset’s legal staff, so that we can commence with the study and proceed to include newborns with suspected jaundice,” says Emma Lif, Clinical Director at Calmark. “The research entity at Sachsska barnsjukhuset is extremely competent, and we are looking forrward to a close and fruitful cooperation.”
Currently, no portable point-of-contact diagnostic instruments on the market are capable of rapid plasma bilirubin analysis. The delay between test and hospital laboratory confirmation is usually about 1-2 hours. A point-of-contact test that provides a result within the minute would therefore shorten the waiting time before receiving treatment – or, if the result is below the threshold for treatment – before going home.
Background: Why is it important to detect high bilirubin levels?
Bilrubin is a waste product from the physiological degradation of red blood cells. The breakdown primarily occurs in the liver, and takes longer in newborns due to their immature liver function. This leads to elevated levels of bilirubin during the first days of life.
Bilirubin is yellow in color, and the majority of newborns develop a slight yellowish tint to the skin in their first week of life. This condition is called neonatal hyperbilirubinemia (neonatal jaundice). In most cases, the jaundice goes away on its own. Some infants, however, need treatment with light exposure (phototherapy) to speed up bilirubin breakdown.
In the Nordic countries, up to 5 percent of all newborns are treated with phototherapy; higher numbers are reported from other parts of the world. A few of the jaundice cases are more severe, and may require exchange blood transfusions. In rare cases, very high bilirubin levels may result in permanent neurological damage, unless the condition is detected and treated in time. Because of this, bilirubin detection is one of the most common neonatal blood tests.
Between 2008 and 2016, 6.8 out of 100,000 newborns in Sweden suffered from severe neonatal jaundice. In the rest of the EU and in the United States, the prevalence was reported to be 7-45/100,000. Low and medium income countries in Asia reported a prevalence of 1,500-3,000/100,000 newborns. In Sweden, 42 percent of the aforementioned severe cases developed one or more symptoms of acute brain disease, and 13 infants developed kernicterus.
Early discovery, monitoring, and initiation of treatment during the first week of life is an efficient method to prevent most cases of serious disease and death due to hyperbilirubinemia. A consensus statement written 2008 by experts within the European and US paediatric associations strongly stressed the importance of being able to determine bilirubin levels within the first 24 hours in cases of visible neonatal jaundice.
This information is information that Calmark Sweden AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on 27 November 2019.
Every care has been taken in the translation of this document. In the event of discrepancies, the Swedish original will supersede the English translation.
For more information about Calmark Sweden AB, please contact:
Anna Söderlund, CEO
Telefon: +46 70 213 25 35
E-post: anna.soderlund@calmark.se
www.calmark.se
Calmark Sweden AB is a medical technology company developing a point-of-care (POC) analyzis method with easier and faster sampling of medical conditions in newborns. The unique test platform, which consists of a reader and single-use products, is expected to be ready for launch in 2020 when three important POC tests are introduced. The WHO estimates that 1.5 billion children will be born worldwide by 2030. In the Western world, the introduction of POC diagnostics is resulting in huge savings and shorter healthcare chains. In less developed healthcare systems, the product helps save lives. Calmark aims to become the global leader and ultimately to offer all relevant POC tests for the first period of life, regardless of where in the world a baby is born. Read more about Calmark www.calmark.se/eng/home.
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