Expert Opinion on Need for Biomarker Panels in Biopsy Decisions
Neal D. Shore, MD, FACS presented abstract 229 regarding the current need for a more accurate diagnostic test to identify patients for prostate biopsy at the 2022 ASCO Genitourinary Cancers Symposium.
The Unmet Need for a Biomarker to Support Imaging and Prevent Unnecessary Biopsies
Professor Mark Emberton OBE, University College London, on his study that aims to improve the current prostate specific antigen (PSA)/biopsy risk stratification for prostate cancer (PCa) and develop a new image-based method with biomarkers like the MiCheck® Prostate for diagnosing high/low risk PCa in men.
MiCheck® Prostate is intended for use as an aid to clinicians in the decision to proceed to prostate biopsy in patients with an elevated PSA.
- MiCheck® Prostate provides a percentage risk of aggressive prostate cancer.
- MiCheck® Prostate has demonstrated the ability to differentiate aggressive from non-aggressive cancer and no cancer.
- MiCheck® Prostate demonstrates a compelling advantage in specificity over existing products, outperforming the benchmark PSA test as well as other tests such as % free PSA and the Prostate Health Index (PHI) in a head-to-head comparison.
- The lack of specificity of other tests has led to criticism due to the resulting unnecessary biopsies. MiCheck® Prostate helps fill this substantial unmet clinical need by allowing a reduction in number of biopsies while minimising the risk of missing out aggressive prostate cancer cases.
✔ Ease of use – blood collection made at the same time as the blood draw for a PSA test.
✔ No interruption to the clinician’s current workflow.
✔ Clear clinical utility – single page well-defined report to help the clinician determine whether the patient needs a biopsy or future follow-up in the coming months.
✔ Timely delivery of results – ready for the patient’s next visit to the clinician.
✔ Dominant health economics in comparison to standard of care.
✔ Early availability as a LDT through a CLIA certified high complexity laboratory.
US CLIA Lab Certification
Minomic International Limited establishes commercial partnership with 20/20 GeneSystems to offer MiCheck® Prostate in the USA
Minomic enters into collaboration with GloriousMed to introduce MiCheck® Prostate into China
Laboratory Developed MiCheck® Prostate Cancer Test Roll-out
MiCheck® Pancreatic Cancer Study Commenced
Completed MiCheck® Prostate Cancer Prospective Trial
Awarded Accelerating Commercialization Grant to Further Product Development
Clinical Validation Studies for MiCheck® Prostate Cancer Commenced