LUND, SWEDEN – Immunovia AB (publ) (“Immunovia”) today provides an update on the status of the company’s activities and as previously reported (Webinar Dec 17, 2020), Immunovia will initiate sales start in Q1 2021 of the company’s first test, IMMray™ PanCan-d designed for early detection of pancreatic cancer.
Since the last update, Immunovia’s R&D and production departments in Lund have been working at full speed to ensure the highest quality reagents and arrays are available for the final blind validation study of IMMray™ PanCan-d. All the necessary samples for the blind validation study have been secured and will be analyzed in Marlborough in Q1.
The dedicated Immunovia Dx Laboratory in Marlborough, USA has recently completed implementation of its quality system and is now in the final preparation stages prior to performing the blind validation study leading up to a Q1 sales start followed by accreditation and commercial testing in Q2 2021.
Immunovia´s commercial team have full focus on the marketing and launch activities in the USA to achieve our sales start of IMMray™ PanCan-d in Q1.
“We are very grateful to our collaborators who collected all the necessary samples for the final step before commercialization, the blind validation study. Immunovia personnel have been working uninterrupted, living up to our values of dedication and commitment despite all the challenges presented daily during these times. We are now looking forward to commercialization start of our first test, IMMray™ PanCan-d and to working with healthcare providers to more effectively detecting pancreatic cancer in its early stages thus making a significant difference for the affected patients”, says Patrik Dahlen, CEO Immunovia.
For more information, please contact:
Patrik Dahlen, CEO, Immunovia
Tel: +46 73 376 76 64
Immunovia AB is a diagnostic company that is developing and commercializing highly accurate blood tests for the early detection of cancer and autoimmune diseases based on Immunovia’s proprietary test platform called IMMray™. Tests are based on antibody biomarker microarray analysis using advanced machine-learning and bioinformatics to single-out a set of relevant biomarkers that indicate a certain disease. Thus, forming a unique “disease biomarker signature”.
The company was founded in 2007, based on cancer studies and ground-breaking research in the Department of Immuntechnology at Lund University and CREATE Health Cancer Center, Sweden.
The first product, IMMray™ PanCan-d, is undergoing clinical evaluation in some of the world’s largest clinical studies for pancreatic cancer, PanFAM-1, PanSYM-1 and PanDIA-1 and is currently in the final validation phase. The company aims for a sales start at the end of Q1 2021 with subsequent commercial testing in Q2.
When validated, IMMray™ PanCan-d will be the first blood-based test for early diagnosis of pancreatic cancer on the market, with a potential to significantly improve patient survival and outcome.
Immunovia Dx Laboratories located in Marlborough, Massachusetts, USA and Lund, Sweden will provide laboratory testing services in two accredited reference laboratories.
Immunovia’s shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com.
Press release (PDF)