Immunovia, Audiocast with teleconference, 2021March 30th 2021 16:30 (Europe/Stockholm)
Immunovia reports positive results of the blinded clinical validation of IMMrayTM PanCan-d blood test in USA
Stage I/II pancreatic cancers were detected with 98% specificity and 85% sensitivity in familial/hereditary risk group cohorts
LUND, SWEDEN ―Immunovia today announced the successful completion of the last development milestone of IMMray™ PanCan-d blood test designed for early detection of pancreatic cancer (PDAC). The blinded validation study data demonstrated that Immunovia’s IMMray™ PanCan-d biomarker signature and CA 19-9 detects early stage I&II pancreatic cancers with a test specificity/sensitivity of 98%/85% vs familial/hereditary controls (reference PanFAM clinicaltrials.gov) and with a specificity/sentitivity of 99%/85% vs healthy controls. All stages of PDAC were detected with a specificity of 98% and a sensitivity of 87% against familial/hereditary controls. The blinded validation study, performed by Immunovia Dx Laboratory in Marlborough USA, analysed 591 samples including 167 PDACs whereof 56 PDAC stage I&II, 203 high risk individuals, and 221 healthy controls. These samples have been freshly collected from 11 sites in the US and Europe: Mt Sinai School of Medicine, Beth Israel Deaconess Medical Center, University of Pittsburgh Medical Center, BioIVT, Discovery Life Sciences, Inc., Massachusetts General Hospital, and University of Pennsylvania in the US; Sahlgrenska University Hospital and Växjö Central Hospital in Sweden; Helsinki University Hospital in Finland; and Ramón y Cajal University Hospital, IRYCIS, CIBERONC in Spain.
MD, PhD, Thomas King, Medical Director Immunovia Dx Laboratory, Marlborough, USA commented: “IMMray™ PanCan-d showing specificities of 98% and 85% sensitivities for early stages of pancreatic cancer versus a cohort of familial/hereditary risk group are a historical breakthrough both for Immunovia and for improving pancreatic cancer survival. We will be filing for the Massachusetts State License and CLIA registration for Immunovia Dx Laboratory in USA as soon as practically possible before commercialization starts in USA”.
Patrik Dahlen, CEO, Immunovia added: “This is a historical moment for Immunovia and we have all been working very hard since the very beginning with this one goal in mind: to provide an accurate and early blood test for pancreatic cancer. For the IMMray™ PanCan-d to now show 99% specificity for early stage pancreatic cancer in a large blinded study is a truly revolutionary advancement for healthcare systems in the way they will test and detect this deadly disease, and will result in great improvements for the patients and their families. It is simply fantastic for us to now enter commercialization in the US.”
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