Immunovia reports (PR, March 29 2021) positive results from blinded clinical validation of IMMray™ PanCan-d blood test performed by Immunovia, Inc. in Marlborough, USA, for stage I/II pancreatic cancers in familial/hereditary risk groups – and improved test performance in detecting early stage pancreatic cancer in high risk symptomatic patients in Lund, Sweden.
Immunovia, Inc. certified by the Clinical Laboratory Improvement Amendments (CLIA) (PR, Aug 4 2021). Commercial launch makes IMMray™ PanCan-d the first blood test for early detection of pancreatic cancer, exclusively available from Immunovia, Inc. For more information visit www.immunoviainc.com.
Prospective studies PanFAM-1 and PanDIA-1 complete sample collection and move to analysis phase. Limited attendance to collection sites due to COVID-19 results in PanSYM-1 primary endpoints not being evaluated and samples being used in commercial test model study of IMMray™ PanCan-d. Work continues to investigate options to validate the test in the symptomatic risk group together with key opinion leader network.
Patent filed for IMMray™ PanCan-d 8 biomarker signature (including CA19-9).
Patrik Dahlen becomes the new CEO of Immunovia AB.
Output of IMMray™ PanCan-d verification study released. Positive results reported in differentiating early stage I/II PDAC patients from healthy controls. The analysis was performed with the locked commercial signature, without any re-training procedure, mirroring the commercial setting.
Long-term goal defined. To reach a market penetration of 30% after reimbursement from the healthcare and insurance systems has been achieved.
Immunovia completes IMMray™ PanCan-d optimization, and announces excellent results across all symptomatic risk groups. Sample collection is expanded to increase ethnic and genetic variation.
University College of London (UCL) expands prospective collection of blood samples for the PanSYM-1 pilot study.
Two new cancer centers in New York and Chicago join PanFAM-1, which is now the most comprehensive prospective study in pancreatic cancer to date.
Optimization study presented at PancreasFest 2019. Results suggest that IMMray™ PanCan-d in combination with CA19-9 is able to differentiate between PDAC, similar symptoms, healthy controls, and type 2 diabetes. Similar results are obtained for all stages of PDAC with ROC AUC values of 0.97, 0.98 and 0.96 respectively.
Immunovia is listed on Nasdaq Stockholm
Journal of Clinical Oncology publishes that IMMray™ PanCan-d serum biomarker test is able to detect early pancreatic cancer with 96% accuracy.
10 more leading research centers join the global, prospective, validation study PanFAM-1, making it the largest clinical study for the early detection of pancreatic cancer in this risk group. PanFAM-1 is registered on ClinicalTrials.gov.
IMMray™ PanCan-d biomarker signature for the diagnosis of pancreatic cancer is patented in Japan.
A collaborative study shows that Immunovia’s IMMray™ platform provides highly accurate diagnosis of non-small cell lung cancer (NSCLC), with an accuracy of 95%.
Breakthrough in autoimmune testing: an IMMray™ based biomarker signature can identify rheumatoid arthritis (RA) with over 90% accuracy, and detect RA in patients testing sero-negative for rheumatoid factor (RF) and anti-CCP.
Start of prospective patient sample collection from symptomatic patients (PanSYM-1) at the University College London Hospital, led by Professor Steve Pereira.
The world’s largest prospective study (PanDIA-1) for pancreatic cancer risk group of patients diagnosed with new onset diabetes after the age of 50 is initiated.
Excellent results from a study regarding differential diagnosis of autoimmune diseases including SLE, RA, Vasculitis and Sjögren’s syndrome are obtained.
Immunovia establishes a US office for the subsidiary Immunovia, Inc. in Marlborough, Massachusetts, USA.
The first collaboration agreements signed for prospective studies in PanFAM-1 (prospective study for familial/hereditary risk group for pancreatic cancer).
Letter of Intent signed with National Cancer Institute (NCI) stating that Immunovia are part of NCI’s program for the pancreatic cancer risk group New Onset Diabetes type II (NOD).
Clinical studies show first encouraging data on the early diagnosis of asymptomatic stage I and II pancreatic cancer, and a study in China shows that the signature works in populations with different genetic backgrounds.
Work to develop and commercialize a diagnostic antibody test platform based on patents held in human antibodies, biomarkers and antibody arrays.
First multicenter studies and clinical trials on pancreatic cancer diagnostics are conducted in Spain.
Immunovia AB founded in Lund, Sweden as a collaboration between the Department of Immunology at Lund University and CREATE Health – Center for Translational Cancer Research.