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Immunovia Completes US Validation Study for Pancreatic Cancer Test

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NEW YORK (GenomeWeb) — Swedish diagnostics firm Immunovia has completed a retrospective clinical validation study for its Immray PanCan-d test for pancreatic cancer.

In the study, which looked at 362 blood samples from patients collected by Oregon Health & Science University, the test identified stage I and II pancreatic cancers with an accuracy of 96 percent.

This matched the test's performance in an earlier retrospective trial that the company completed last year. In that trial, which looked at 1,400 samples from a European patient cohort, the test also identified stage I and II pancreatic cancers with an accuracy of 96 percent.

The recently completed study demonstrates that the test "works just as well on American [patients]," Immunovia CEO Mats Grahn told GenomeWeb. "More importantly," he added, "we used exactly the same biomarker combination without any modifications, and we got the same results, showing that it is a very stable finding that we made in the first study."

Additionally, while the first trial did not include patients with conditions that present similarly to pancreatic cancer, such as pancreatitis, the OHSU cohort did include such patients, Chris Corless, executive director and chief medical officer of OHSU's Knight Diagnostics Lab and a professor of pathology, told GenomeWeb.

"There is interest, of course, in establishing that the assay shows specificity against these other disease conditions, and so far the data look very good," he said.

The test's performance in early-stage patients is of particular note, as early detection is one of the biggest challenges in treating pancreatic cancer. According to Immunovia, the five-year survival rate for the disease is between 4 percent and 6 percent. This could rise to between 50 percent and 60 percent were the disease detected at stage I or II, when tumors can be resected via surgery, the company said.

In a separate trial of 213 Han Chinese patients performed in collaboration with China's Tianjin Medical University Cancer Institute and Hospital, the test distinguished between stage I disease and health controls with an AUC of .71, stage II and healthy controls with an AUC of .86, stage III and healthy controls with an AUC of .90, and stage IV and healthy controls with an AUC of .93.

"We have data now from three different sets of specimens, and it all seems to support the same thing — that the assay is picking up cancer even down to stage I," Corless said, adding that the performance of the test surpassed any others he had seen in detecting early-stage pancreatic cancer.

"We are always looking for potential partners to bring new assays into clinical use, and amongst the many companies we've talked to Immunovia stood out because their assay is so far developed and looks to be very promising," Corless said of OHSU's interest in the test. Under OHSU's agreement with Immunovia, the institution received rights to commercialize the test in the US west of the Mississippi River in exchange for its clinical samples and help validating the assay.

The next step in developing the test is a prospective validation study, which Immunovia is currently putting together at clinical sites including OHSU, Mount Sinai Hospital in New York City, and the University of Liverpool, Grahn said. The company plans to start enrolling patients at the end of the year with the goal of following around 1,000 patients over three years.

Immunovia plans to launch the test in 2017, with the US, Germany, and Scandinavia its top priority markets initially. In the US it plans first to offer the test by partnering with CLIA labs like OHSU's Knight Diagnostics Labs, though Corless said the company does plan eventually to take the assay through the US Food and Drug Administration.

Corless said the test would be used for assessing high-risk patients, noting that even with the high accuracy demonstrated in the retrospective studies the test would still generate too many false positives to be used as a general screening tool.

"If someone comes in the door and they have unexplained pancreatitis and the imaging is unclear as to what is going on, you do this assay and you should get a pretty good idea right away of whether you are dealing with a cancer or not," he said.

Typically, symptomatic patients are evaluated using various imaging techniques like CT scans and ultrasound. However, Corless said, results from the tests are sometimes inconclusive, which makes an additional test like the Immray PanCan-d test potentially useful.

One challenge in treating pancreatic cancer is the fact that in many cases, by the time patients are symptomatic, the cancer has progressed too far for it to be treated effectively. Given that the Immray PanCan-d test will likely be intended for use in symptomatic patients, it could have limited usefulness in such cases.

However, Corless said, "it can also happen that symptoms are presenting at a time where the disease is still curable by surgery but it isn't clear from imaging that there is a cancer there. So, here you would have something that is pointing in the direction that says that you really need to pursue a potential cancer in this patient even if you can't see it."

Additionally, he said, the test could be useful for monitoring patients who have a family history of pancreatic cancer or in older patients who suddenly develop unexplained type II diabetes, which is occasionally due to pancreatic cancer.

"We are not saying this test will supplant anything that is currently going on," Corless said. "We are proposing that it will be a very helpful adjunct, especially when things just aren't clear cut."

He added that OHSU is currently discussing a collaboration with Immunovia on a test for another cancer, though he did not say which.

"One of the things that is attractive about their platform is that this is essentially just the first of many assays that can be built [on it]," he said.

Founded in 2007 by Lund University scientists including Carl Borrebaeck, Immunovia uses antibody microarray technologies developed in Borrebaeck's lab for its protein diagnostics work. In addition to its lead program in pancreatic cancer, the company also has projects focused on prostate and breast cancer and autoimmune diseases including lupus.

The company's IMMray platform uses arrays of human recombinant scFv antibodies. The discovery version of the platform contains antibodies to around 500 plasma proteins targets, focused mainly on proteins related to the immune system as well as secreted proteins. The company processes the data from this discovery platform using a proprietary bioinformatics pipeline and winnows down the original discovery panel to diagnostic panels of typically between 15 and 25 proteins.

The pancreatic cancer panel consists of around 25 proteins, and the company is currently patenting additional proteins as possible components of the test, Grahn said.

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