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Hemcheck Sweden AB: Etikprövningsnämnden godkänner HemChecks ansökan - Regulatorisk

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ETIKPRÖVNINGSNÄMNDEN GODKÄNNER HEMCHECKS ANSÖKAN

Vid sitt sammanträde i oktober beslutade Etikprövningsnämnden i Uppsala att godkänna HemChecks ansökan om att få genomföra en studie bestående av en metodjämförelse vid akutmottagningen och det kliniska kemilaboratoriet vid Centralsjukhuset i Karlstad.

-Det är ett mycket glädjande beslut för HemCheck. Det innebär att vi, på hemmaplan i Karlstad, kommer att kunna testa funktion och tillförlitlighet för vårt vidareutvecklade produktkoncept Helge®, bestående av engångstest och avläsare, säger HemChecks vd Annelie Brolinson i en kommentar.

Avsikten med studien är att undersöka om HemChecks patientnära hemolystest i direkt samband med blodprovstagningen kan upptäcka hemolyserade blodprover redan innan de skickas vidare till laboratoriet för analys. Detta i jämförelse med dagens metod där hemolysdetektionen sker först på laboratoriet.

   -Den viktigaste frågeställningen i studien är att undersöka hur stor andel av proverna som kan upptäckas med ett patientnära hemolystest, säger Annelie Brolinson. Vår utgångspunkt är att ett väl fungerande patientnära test kan förbättra patientflöden och ge minskat resursslöseri.

-Hemolyserade blodprov är ett reellt problem inom sjukvården vilket kan medföra onödig väntan för patienter och merkostnad för sjukvården. HemChecks lösning är intressant på flera sätt. Vi ser därför fram emot att genomföra studien i samarbete med bolaget, säger Magnus Nylén, avdelningschef akutmottagningen i Karlstad.

Inom ramen för den planerade kliniska prövningen har HemCheck ingått ett lokalt avtal med akutmottagningen i Karlstad.

Enligt lag måste varje forskare som vill genomföra forskning på levande och eller avlidna personer, på biologiskt material från människor, samt forskning som innebär hantering av känsliga personuppgifter, ansöka om tillstånd hos regionala etikprövningsnämnder. Det finns sammanlagt sex sådana regionala nämnder vid universiteten Göteborg, Linköping, Lund, Umeå, Umeå och Uppsala, samt vid Karolinska Institutet i Stockholm. Den Centrala etikprövningsnämnden har sitt kansli hos Vetenskapsrådet i Stockholm.

För vidare information, kontakta:
Hemcheck Sweden AB (publ) Annelie Brolinson, vd
Tel: +46 70 288 0826
E-post: annelie.brolinson@hemcheck.com

Om HemCheck
Hemcheck Sweden AB (publ) utvecklar och kommersialiserar ett unikt produktkoncept, Helge, för patientnära detektion av hemolys. Hemolys, trasiga röda blodkroppar, är den vanligaste orsaken till att blodprov inte kan analyseras. Detta leder till sämre vård, risker för patienter och höga kostnader för samhället. HemChecks mål är att bidra till en förbättrad vård för patienter över hela världen genom att utveckla och kommersialisera användarvänliga produkter för detektion av hemolyserade blodprover i direkt anslutning till provtagningen. HemChecks huvudkontor finns i Karlstad, Sverige.

Viktig information
Denna information är sådan information som hemCheck är skyldigt att offentliggöra enligt EU:s marknadsmissbruksförordning. Informationen lämnades, genom ovanstående kontaktpersons försorg, för offentliggörande den 26 oktober 2017 kl. 15.00




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Hemcheck Sweden AB via Globenewswire

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