Immunovia has announced improved performance of its blood based IMMray PanCan-d test and positive results from a blinded clinical validation of the test in US.

The company has announced the successful completion of the last development milestone of IMMray PanCan-d blood test designed for early detection of pancreatic cancer (PDAC). A 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 and with a specificity/sensitivity 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.

Commercialization in the US

The blinded validation study, performed by Immunovia Dx Laboratory in Marlborough USA, analyzed 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.

“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.”

“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,” says Patrik Dahlen, CEO, Immunovia, in a press release.

Detects pancreatic cancers (all stages) with 92% specificity and 81% sensitivity

The company also announced improved performance of the blood based IMMray PanCan-d biomarker signature together with CA 19-9 in a clinical retrospective study. The study was designed to evaluate detection of early stage pancreatic cancer in high risk patients with non-specific but concerning symptoms. The study data demonstrate that Immunovia’s test now detects pancreatic cancers (all stages) with 92% specificity and 81% sensitivity for this cohort, which is equivalent to results presented in the previous Commercial Test Model Study. Importantly, early stage PDAC I/II were detected with specificity of 92% and sensitivity of 80%.

The improved test performance was demonstrated in a combined samples cohort of newly collected samples and samples from the Clinical Verification study. In total 433 samples of which 202 were PDACs whereof 89 PDAC stage I/II and 231 symptomatic controls were analyzed. These samples have been freshly collected from 7 sites in the US and Europe.

“The market size for the symptomatic risk group is 1-2 million patients in USA and Europe.”

“These results further confirm the commercialization strategy for this important risk group of patients. The market size for the symptomatic risk group is 1-2 million patients in USA and Europe,” says Patrik Dahlen, CEO, Immunovia, in a press release.

Learn more about Immunovia’s journey so far and their commercialization strategy in our upcoming issue of the magazine, out April 20th!

Photo of Patrik Dahlen: Immunovia