Scientific background of Thestra´s EPLINEx™ method is reported in EMBO Molecular Medicine, a leading medical journal. The findings were validated across all Finnish university hospitals on the use of a diagnostic LIMA1-alpha IHC assay for HPV-negative HNSCC patient stratification to surgery-only therapy. The article will be featured as a front-page story of August issue and highlighted on their social media channels and EMBO Press website. This is a great recognition for the importance of LIMA1-alpha IHC assay in HNSCC patient stratification.
Thestra´s further R&D supported by Business Finland has led to the development of LIMA1 antibody-based EPLINEx™ method for the diagnosis of aggressively metastasizing head and neck cancer (HNSCC) based on these now recognized findings. This kind of test has been missing from the market despite decades of related research. There are currently only two biomarkers—p16 and PD-L1—in widespread clinical use for HNSCC, and both have serious limitations in stratifying treatment for early-stage disease.
Thestra trusts that this can mark a real turning point in personalized head and neck cancer care and envisions that EPLINEx™ testing will be incorporated into routine HNSCC diagnostic workflows to guide treatment planning from the outset. It is also worth noticing that EPLINEx™ method can be implemented into already existing IHC staining automats. Thus, there will be no need for investments in new diagnostic laboratory equipment infrastructure. Thestra plans to bring EPLINEx™ method to patient use by 2026.
Alexandra Gylfe of Nordic Science Investments comments these developments as follows:
“Rarely do we see a biomarker outperform others so clearly in multivariable analysis. LIMA1-alpha shows exceptional specificity and prognostic power, which could revolutionize surgical decision-making”.
Importantly, the diagnostic performance of LIMA1-alpha in recognizing aggressive cancers does not seem to be restricted to HNSCC, as both the EMBO Molecular Medicine article, and a recent independent publication (https://www.sciencedirect.com/science/article/pii/S1534580725004034), demonstrated that high LIMA1-alpha expression associates with more aggressive tumours in pancreatic and breast cancers.
EPLINEx™ technology is protected by patent (pending) and trademark. The basic research on which the product is based has been supported by funding from the Academy of Finland and the Jane and Aatos Erkko Foundation, and Novo Nordisk Foundation. The technology has been further refined before the company was founded with Business Finland’s ”Research-to-Business” (R2B) funding.
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