miR Scientific, LLC is a precision molecular bioscience company that has developed liquid biopsy urine tests to definitively detect prostate and bladder cancers. miR’s platform has the ability to distinguish between aggressive and indolent prostate and bladder tumors prior to potentially life-changing interventions. The Company creates and delivers scalable breakthrough technolo- gies for the provision of accessible diagnostic, prognostic, monitoring and companion products and services for large at-risk cancer populations, effectively rendering it a cancer management platform. miR’s powerful platform technology can have a profound impact on reducing deaths and adverse side effects such as additional medical procedures, impairment to quality-of-life and cost-of-care for bladder and prostate cancer patients. miR’s use of proprietary miRNA and sncRNA profiling provides an unprecedented level of accuracy (>98.6% sensitivity and 99% specificity) which, together with its low cost and ease of administration, positions miR’s cancer management platform to become the next-generation global standard of care for the early detection of prostate and bladder cancers.
The Company has operated its own laboratories since mid-2014 and to date has successfully tested over 5,000 clinical patient samples. miR has filed for multiple provisional patents, and Institutional Review Board protocol approvals allowing clinical research are in place. miR’s product pipeline includes the Prostate Cancer Sentinel Assay TestTM, a urine-based liquid biopsy test with unprecedented accuracy that has the potential to save thousands of men from suffering the possible severe side effects of unnecessary prostate cancer treatments. This non-invasive liquid biopsy screening test interrogates the sncRNA profiles isolated from urinary exosomes that, in combination with the Company’s proprietary and novel statistical prediction algorithm, accurately classifies future patients into those who have prostate cancer and those who do not. The Company’s clinical studies validated the results at 99% sensitivity and 95% specificity. The study was conducted through the implementation of miR-PDxTM as an initial screen for prostate cancer that was utilized in place of the prostate-specific antigen (PSA) screening test. The Prostate Cancer Sentinel Assay TestTM is miR’s first commercial test and is expected to launch in Q2 2019. Another of miR’s products includes the miR-BCPxTM, which is a non-invasive liquid biopsy surveillance screen for bladder cancer patients. The miR-BCPxTM is an alternative to cystoscopy with results yielding 100% sensitivity and 96% specificity.
The Company collaborates with multiple clinical sites that produce patient samples for clinical, regulatory and reimbursement-related analysis and expects to establish its own certified clinical lab by Q1 2019. miR is participating in an industry-lead- ing clinical program with the world-renowned Canadian Urology Research Consortium (CURC). miR also has a formal collaboration agreement with SUNY Downstate Medical Center (jointly with Kings County Hospital) and Albany Medical College that provided the data for the submission of two abstracts and a poster presentation at the American Society of Clinical Oncology at its annual meeting in June 2018. miR’s findings have received key opinion leader sign-offs and are supported by additional intellectual property filings. The Company is well-positioned to explore strategic partnerships with key manufacturers, akin to the Grail-Illumina partnership, and plans in parallel to pursue regulatory approvals and certifications that will enable it to offer its products in key markets including the United States, Canada, Latin America, Europe and Asia.
The miR platform, with its high specificity, sensitivity and unbiased approach, offers much-needed accuracy to make critical early decisions about cancer care. miR’s cancer management innovations represent the first-ever opportunity for patients and physicians to have timely, accurate, actionable data to optimize treatment for these cancers prior to potentially life-changing interventions. miR’s technology extracts sncRNAs from urine or core needle biopsies, providing the medical community with the ability to detect and process, with high specificity and sensitivity, signals from hundreds of sncRNAs that are produced at or near the first inception of a tumor. The miR screening platform does not rely on the presumption that all urogenital tumors develop in the same way, and can therefore be detected based on the presence of a single or even a handful of biomarkers. miR’s data science platform provides highly specific actionable information with an industry leading low false-positive and effectively zero false-negative accuracy rate.
Our technologies are designed to be accessible to family physicians, urologists, lab technicians, health insurance actuaries, bioinstrumentation experts and medical/research device manufacturers. This approach ensures that miR’s revolutionary cancer management platform can be available to any patient in any country with an accredited medical and logistical infrastructure.
miR Scientific, LLC
1 Discovery Drive
Rensselaer, NY 12144
+1 (518) 591-7218
United States, Israel & Canada