OncoAssure

OncoAssure has its origins in OncoMark Ltd. where the OncoMasTR Assay for early-stage Breast cancer was developed. OncoMark was acquired by Cepheid Inc. (a Division of Danaher) in 2021, and at the same time OncoAssure was established to continue the development of tests in other human cancers outside of Breast Cancer.

Since 2021 OncoAssure has developed, validated and more recently launched the OncoAssure Prostate Cancer Test. OncoAssure Prostate is a biopsy-based molecular test designed to identify patients with low-risk prostate cancer who can be safely managed with active surveillance, thus avoiding significant life-long side-effects associated with aggressive treatments.

Key highlights:

• Clinical validation was successfully completed using two prostate cancer patient cohorts from Skane University Hospital in Sweden and the results presented at the European Society of Medical Oncology Conference in Paris in Sept. 2022 
• Certification: OncoAssure prostate was transferred to a US CLIA lab in 2024 and certified as an LDT (Laboratory Developed Test).  
• The product is at commercialisation stage.
•  OncoAssure Prostate is a biopsy-based molecular test designed to identify patients with low-risk prostate cancer who can be safely managed with active surveillance, thus avoiding significant life-long side-effects associated with aggressive treatments. 
• Unmet clinical need: Current clinical tools cannot determine the true risk of progression, thus accurately identifying patients with aggressive prostate cancer represents a major clinical unmet need.
• Prostate cancer is the second most common cancer in men and represents 26% of all male cancer diagnoses.
•  An application was made to CMS (Medicare) for reimbursement, which was successfully achieved in Nov. 2024 (CPT Code and a premium reimbursement rate of $3,873 per test).
• Sales revenues expected to reach EUR2.5M in 2028 and EUR5.7M in 2029. These revenues are driven mainly by the exceptional re-imbursement rate for the test @ $3,873. The high pricing of these tests gives exceptional margins, profitability & value.
• Strong management team with excellent track record of successful developments and exits in the industry. In effect, this is the same team using the same 'playbook' which secured a successful exit with breast cancer/OncoMark sale.
• A European Patent Application (No. EP22165911.3) was filed with priority date March 31st, 2022. 'A Method of Predicting Risk of an Aggressive or Recurrent Cancer'
• The two promoters of the business have invested over EUR1.1m in OncoAssure to date. 
• Current funding round of up to EUR1.5m has pre-secured commitments of EUR1.138m from a variety of specialist medical investment syndicates and influential angel investors.