NEW YORK (GenomeWeb) – Sweden-based antibody array diagnostics firm Immunovia said today that it has started a multi-center prospective validation study of its Immray PanCan-d test for the early diagnosis of individuals at high risk for familial pancreatic cancer (FPC).
The longitudinal clinical study, called Panfam-1, will use the company's blood test to analyze 1,000 people at high risk for FPC over a period of three years. The subjects will be recruited at sites in the US and in Europe that offer FPC screening programs.
The Ramon y Cajal Institute for Health Research (IRYCIS) in Spain has already started collecting blood samples. Mount Sinai in New York, the Knight Cancer Institute at Oregon Health and Sciences University, and the University of Liverpool are expected to start collecting samples in the near future. In addition, Immunovia is in discussions with several other pancreatic cancer surveillance programs in Europe and the US about their participation in the study.
"For Immunovia, the start of the prospective validation of Immray PanCan-d is a critical milestone which will provide us with the clinical evidence for the test," said Immunovia CEO Mats Grahn in a statement. The results will also be important for regulatory applications and reimbursement, he added.
The new study follows a retrospective clinical validation study of Immray PanCan-d that the company completed earlier this year.
Immunovia was founded in 2007 as a spinout from the Department of Immunotechnology at Lund University and the Center for Translational Cancer Research in Lund, Sweden. It uses antibody microarray technology originally developed in the laboratory of Carl Borrebaeck. Besides its pancreatic cancer test, the company also has a program for autoimmune disease diagnosis, prognosis, and therapy monitoring, which it started earlier this year.