Glycanostics is an innovative start-up company established in 2017 to bring its revolutionary cancer diagnostics products to the US and EU markets. The company was founded by two scientists Jan Tkac, DSc and Tomas Bertok, PhD who got international recognition for their scientific works, prestigious grants and awards winners such as Scientists of the year (Slovakia) or European Research Council (ERC) Consolidator grant. Glycanostics develops and will sell glycan-based, accurate, affordable and non-invasive tests for cancer diagnostics in early stages which could save thousands of people’s lives and prevent unnecessary treatment. Diagnostics is done by the analysis of glycan changes on specific proteins like a prostate-specific antigen (PSA) in a non-invasive way. The tests are designed to help doctors to make a proper decision about a need to perform a biopsy or to check the patient after the biopsy, which misses 30% of prostate cancer patients. The feasibility assessment revolved around four main objectives: clinical validation, regulatory and commercialization assessment, strategy for sales and business model refinement.
Objectives:
(1) In collaboration with science advisors, KOLs and other clinicians, the objective was to perform pre-clinical validations of the PCa DX kit and Prostate check home test using serum samples from the biobank.
(2) Based on the GAP analysis, the team researched necessary regulations leading to certification of the PCa DX kit and Prostate check home test. A detailed layout for clinical relevance validation and subsequent EMA approvals were designed.
(3) Our marketing & sales strategy ran in parallel with clinical validation and certification process by building a network of KOLs using our team, science advisors, key partners. Later, we designed a strategy built on personal contacts, B2B, B2C, SEO, email marketing, PR events, articles/blogs to create direct sales to clinical labs under Glycanostics.
(4) To establish the best go-to-market strategy, we assessed the production costs, distribution channels and fine-tuned our business model.
