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Immunovia Expands Application of Pancreatic Cancer Test in Swedish Diabetes Study

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NEW YORK (GenomeWeb) – Immunovia, a Swedish molecular diagnostics company, has initiated a new study with academic collaborators to diagnose early-stage pancreatic cancer in new onset diabetes patients.

Over the next three years, Immunovia and its partners will use the firm's Immray PanCan-d assay to screen 6,000 diabetes patients for pancreatic cancer. The study, called PanDIA-1, is in line with a Swedish government objective to introduce a national screening program for addressing diabetes comorbidities.

The project, which includes Lund University Diabetes Center, Uppsala University, Healthcare Region Skåne, and Region Uppsala, is supported by a SEK 7.6 million ($926,000) grant from Swelife, the Swedish government’s strategic innovation program.

Laura Chirica, chief commercial officer at Lund-based Immunovia, said that there has been a trend in recent years toward looking at diabetes as a precursor to developing pancreatic cancer, meaning that diabetics should be considered a high-risk group for the disease.

"It has become more obvious that this is one of the major complications of having diabetes," Chirica said. "After three years of diagnosis, you have a 10-times higher risk of developing pancreatic cancer."

Immray PanCan-d is Immunovia's flagship assay and relies on an antibody microarray designed to measure around 25 biomarkers associated with pancreatic cancer, along with an internally developed bioinformatics platform. Using PanCan-d, clinicians can detect stage I and II pancreatic cancers when the cancer is still resectable.

The company last year launched PanFAM-1, a multinational, multicenter clinical validation study for applying PanCan-d in familial pancreatic cancer. Last week, the company announced that it had added two new partners, Sahlgrenska University Hospital in Sweden, and the University of Pittsburgh, to that study.

Other PanFAM-1 participants include the Ramon y Cajal Institute for Health Research in Spain, Mount Sinai Health System in New York, the Knight Cancer Institute at Oregon Health and Sciences University, and the University of Liverpool.

PanDIA-1, therefore, expands the application of Immray PanCan-d into a new risk group -- patients over the age of 50 with new onset diabetes.

Chirica said that Immunovia stands to benefit from taking part in the new study as it prepares to launch PanCan-d via its laboratories in Lund and at its US subsidiary in Boston in a year. Immunovia established its Boston subsidiary in June.

"To be able to get access to such a large number of samples, all gathered with the same standard operating procedures, clinical reports and records, and everything needed for the test in this particular clinical application is a fantastic opportunity for us," she said. "We will use data collected as a foundation for gaining reimbursement, not only in Sweden, but in a global manner," she added.

Chirica noted that Immunovia will be seeking to add partners to PanDIA-1 in other countries, similar to how it has pursued PanFAM-1. "We will be working with this data anywhere and adding to it," she said. In a statement, CEO Mats Grahn affirmed that the company is already in discussions with "several other healthcare organizations internationally" to expand PanDIA-1.

As it pursues PanDIA-1, Immunovia is also preparing for a commercial launch in the next 12 months. Chirica said that the firm should attain ISO accreditation for its laboratory in Lund in 2018, while it also prepares to obtain a CE-IVD mark for the test in Europe. Both objectives should be achieved by the end of 2018 or the beginning of 2019, she said.

Meantime, the company is also eyeing a submission to the US Food and Drug Administration in the same time frame, Chirica said.

Given that PanDIA-1 is a three-year study, she said that it would not directly influence the launch of the test, though data from the first year could be used to register the test for clinical use. The company is more focused on using the data from PanDIA-1 to win reimbursement from Swedish health authorities based on its performance in a large prospective study.

"It will be help us, in that we will be able to show cases and evidence for [our claims]," she said.

However, Immunovia will market PanCan-d for screening new onset diabetes patients for pancreatic cancer when it introduces the test via its Lund and Boston labs next year. "We are aiming to include three clinical applications in our launch:  after 50 new onset diabetes, familial risk, and vague symptoms of pancreatic cancer," Chirica said. "It will be part of our strategy in the US."

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. 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. In October, Immunovia announced that it had partnered with Linköping University in Sweden to develop biomarkers for autoimmune diseases for use on the Immray platform. The collaboration included research programs on rheumatoid arthritis, Sjögren's syndrome, systemic lupus erythematosus (SLE), and vasculitis.

Chirica said that the ongoing studies with its partners in the area of autoimmune diseases had delivered "extremely promising results," and added the company has been encouraged by the studies and is running additional ones. Chirica declined to elaborate, but said that Immunovia and its partners would describe the outcome of their work in publications soon.

"I think the opportunity we have in autoimmune diseases is amazing," she said. "Our platform is built for reading the immune system, and so it lends itself extremely well to autoimmune disease diagnostics."

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