Update On Commercialization Of Immunovia’s IMMray™ PanCan-d Blood-Based Diagnostic

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Immunovia AB has announced an update on the optimization process to refine the algorithms and eliminate any potential variations for its commercial version of IMMray™ PanCan-d designed for early detection of pancreatic cancer.

Immunovia AB was founded in 2007 by investigators from the Department of Immunotechnology at Lund University and CREATE Health, the Center for Translational Cancer Research in Lund, Sweden. Immunovia’s strategy is to decipher the wealth of information in blood and translate it into clinically useful tools to diagnose complex diseases such as cancer, earlier and more accurately than previously possible.

Immunovia´s core technology platform, IMMray™, is based on antibody biomarker microarray analysis. The company is now performing clinical validation studies for the commercialization of IMMray™ PanCan-d that could be the first blood-based test for early diagnosis of pancreatic cancer. In the beginning of 2016, the company started a program focused on autoimmune diseases diagnosis, prognosis and therapy monitoring.

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As Immunovia previously announced in August 2018, the combination of retrospective samples from different biobanks, with varying sample collection procedures and storage time, introduced unforeseen variability in the test algorithm performance.

The distorting effect caused by the variability in blood sampling procedures was eliminated by consistent and optimal protocols. The completion of the optimization work will then trigger the commercial test model study, followed by Verification and Validation studies.  Details on timing of these milestones will be communicated at the end of April 2019.

“The need for further optimization work was previously announced in August 2018 and during the past six months, we have been working diligently on the optimization of the algorithm. As was indicated by the tests that were performed, using as fresh samples as possible increases the test performance. Through our large and growing network of influential key opinion leaders, we were able to secure the relevant samples needed to complete the optimization work.”

“It is imperative to note that we need samples that best mirror the blood samples that will be used with our final product. Like any diagnostics development company, finding these fresh samples and gaining access to them is quite difficult and takes time. Thanks to our experienced KOLs, we now have these at hand to complete the optimization work. Going forward, the verification and validation process of IMMray™ PanCan-d will be conducted solely with samples collected that best conforms to real-life, commercial conditions.”

“We remain confident that the steps taken to obtain blood samples that best match the samples that will eventually be used by clinicians in the diagnosis process is the key element for the final adjustments before our commercial launch.”  – Mats Grahn, CEO, Immunovia

Sources

  1. https://www.prnewswire.com/news-releases/immunovia-provides-an-update-on-the-optimization-work-to-meet-the-expected-performance-for-commercialization-of-immray-pancan-d-300805664.html
  2. https://immunovia.com/investors/press-releases/?id=3759
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