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Immunovia's Blood-Based Array Test for Lupus Advances in New Study

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NEW YORK (GenomeWeb) – Immunovia, a Swedish diagnostics company, said this week that it can distinguish patients suffering from systemic lupus erythematosus from those with other autoimmune diseases using its antibody array platform.

Laura Chirica, chief commercial officer at the Lund-based firm, said in an interview that Immunovia has used its flagship Immray microarray screening tool to look at about 400 samples from patients with SLE and other common autoimmune diseases, like rheumatoid arthritis, vasculitis, and Sjögren's syndrome.

Because these various diseases often have the same symptoms, it can take patients up to three years to obtain a diagnosis, Chrica said. Using Immunovia's blood-based test, investigators were able to identify SLE patients on the basis of a protein biomarker signature with accuracy of around 90 percent.

The results, which Chirica noted are preliminary, have encouraged the company in its plans to develop and launch a test for SLE based on the Immray platform.

"SLE is called the great imitator as the disease mimics several other autoimmune diseases," Chirica said. "This kind of test or differentiating tool has been needed for a long time."

According to Chirica, there is no single specific diagnostic for SLE available at the moment, and the markers associated with a flare-up of the disease are poor. Physicians divide lupus patients into four phenotypes and the number of tests used to achieve a diagnosis can exceed a dozen.

"Under current diagnostic protocols, patients may undergo 15 different tests, moving from department to department for up to three years before they receive a diagnosis," she said.

Immunovia therefore thinks its test could fill a clinical need. CEO Mats Grahn said in a statement that the company will nowdedicate more effort to the test, which the firm calls Immray SLE-d. Grahn noted that Immunovia will continue to study the assay while it pursues partnerships with experts and initiates clinical studies to optimize its performance and validate it.

The company carried out the study with Lund University's Center of Innovative Decoding of Autoimmunity (IDEA), a cross-disciplinary research center led by Christer Wingren, an Immunovia co-founder who also serves as the company's chief technology officer.

Immunovia and its partners received a SEK2 million ($220,000) grant in February 2016 from Vinnova, the Swedish Governmental Agency for Innovation System, to support the study, and Chirica said the effort was carried out with additional financial backing from Immunovia and Lund University.

Wingren said in an interview that Immunovia's array could distinguish between SLE patients and healthy patients in the past. This is the first time, though, that the firm has been able to separate SLE patients from those suffering from other common autoimmune diseases based on their biomarker signatures.

Still, Wingren said he was "not surprised" by the assay's performance, noting that its high accuracy was in line with earlier internal assessments.

"We hoped we would wind up in that range," Wingren said. "This highlights the validity of our approach."

Immunovia's Immray platform uses arrays of human recombinant single-chain fragment variable (scFv) antibodies. Wingren said that the company used the discovery version of the platform in the new study, which contains antibodies to around 500 plasma protein targets, mainly related to the immune system. Immunovia analyzes the data using its proprietary bioinformatics platform.

Wingren noted that the firm maintains its own antibody library, antibody production and purification systems, as well as its own microarray production. All of these factors, he argued, contributed to the performance of its SLE test in the new study.

"The underlying reason why we were successful is the way we approached technology development, from designing the antibodies to running the assay to the bioinformatics," Wingren said.

"We adopted a cross-disciplinary approach, which is quite different from what our early competitors did," he said. "I think that's the main reason we were able to develop such a high-performance platform."

The company does have its share of competitors, some of whom are also seeking to deploy assays for SLE to the clinical market. Rehovot, Israel-based ImmunArray, for example, has developed a blood-based microarray test called SLE-Key that it says can be used to rule out SLE. Closer to Immunovia in Europe is Protagen, a Dortmund, Germany-based company that has plans to debut a blood-based multiplex protein array for lupus called Multilisa SLE later this year.

When asked about competition, Wingren stressed the technical performance of Immunovia's platform. "Protagen´s platform is based on autoantibodies; we look at different ranges of biomarkers and we have a totally different technology and way of choosing the biomarkers," he said. "However, we have not done a direct comparison yet," he noted.

The market is certainly of interest to Immunovia and other companies. The Lupus Foundation of America estimates that about 5 million people suffer from the disease worldwide, with 1.5 million of them in the US. Still, Chirica noted than more than half of patients are misdiagnosed at first, providing an opportunity for tests from Immunovia and others.

And while the test is in the preliminary stages of being studied, Chirica said, it costs the firm about $500 to run the assay, a price that would likely come down based on testing volumes. While there is no fixed cost related to obtaining an SLE diagnosis, with such a high rate of misdiagnosis and lengthy time for obtaining a correct diagnosis, that offer might be attractive to clinicians.

But first, the company needs to proceed with developing the test.

Wingren said that Immunovia will continue to study the assay in its current setting, and will eventually publish those results. It's also possible that since the firm can identify SLE patients with its array, it might be able to diagnose patients with RA, Sjögren's syndrome, or vasculitis the same way, opportunities that could allow the firm to build out a full menu of tests for autoimmune diseases.

"If you consider that the main strength of our technology is that it measures immune system response, then it is easy to understand why autoimmune disease testing is an important application," said Chirica.

Cancer, too

Immunovia was founded in 2007 by scientists at Lund University, including Wingren. The company's long-held goal has been to parlay the Immray platform into multiple diagnostic tools while serving the clinical immunoproteomics research market.

The company has traded on Nasdaq's Stockholm-based First North market since 2015 and has raising SEK218.6 million to date. While it has developed an interest in making diagnostics for autoimmune diseases, the company has actually focused most of its efforts on cancer diagnostics to date, advancing a 25-marker, blood-based test called Immray PanCan-d that it argues can detect Stage I and Stage II pancreatic cancer.

"Initially we were focused on cancer, but it became obvious that we could use biomarkers to target autoimmunity," said Wingren.

Immunovia in December announced a new multicenter prospective validation study with partners in Europe and the US to validate PanCan-d in a thousand patients with a family history of pancreatic cancer.

Earlier this week, it announced that the University of Michigan Pancreatic Cancer Center would join the longitudinal trial, which is called PANFAM-1 and will take place over the next three years.

Other participating institutions include Mount Sinai in New York, the Knight Cancer Institute at Oregon Health and Sciences University, the Ramón y Cajal Health Research Institute in Madrid, and the University of Liverpool.

The new study follows a retrospective clinical validation study of Immray PanCan-d that the company completed last year.

Immunovia has said it plans to launch PanCan-d this year, initially in the US, Germany, and Scandinavia.

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