Developing and Commercializing Diagnostic Testsfor Unmet Clinical Needs
Products & Programs
Miraculins is dedicated to the development and commercialization of diagnostic tests for diseases and conditions that are lacking highly sensitive and specific tests.
PREVU* Skin Cholesterol
Preeclampsia
Research & Technology
Miraculins is focused on acquiring diagnostic technologies that have gone through early research and discovery stages at the university or research institution level, but are not yet ready for commercialization. The Company adds value by developing the technology into clinical grade quality and by driving it through regulatory approval and ultimately to sales.
Scientific Team
The Miraculins Advantage
Intellectual Property
The PreVu® Non-Invasive Skin Cholesterol Test
The Miraculins advantage
Miraculins focuses on in-licensing/acquiring and developing both cancer and non-cancer diagnostic opportunities that have completed early stage research and address unmet clinical needs.
Miraculins’ internal research program has lead to the discovery and identification of prostate cancer biomarkers, the lead marker of which is called Prostate Secretory Protein or PSP94. Miraculins also acquired several biomarkers in the areas of Gastric, Colorectal, and Pancreatic Cancer and are in the process of moving those programs further through the pipeline.
With the experience gained from developing its first assay, and the addition of a strong scientific team, Miraculins has developed a process and criteria for evaluating technologies as potential licensing targets.
Once Miraculins has determined that a specific technology meets its criteria the Company adds value to the early stage research by developing a clinical grade assay, confirming the diagnostic potential of the technology and moving the test through to regulatory approval and commercial sales.
Miraculins therefore bridges the gap between early stage research, completed at the university/institution level, and clinical grade commercial assays.
Under its new business model, Miraculins has acquired a panel of Preeclampsia biomarkers from Mount Sinai Hospital and partnered the program with Inverness Medical Innovations (NYSE:IMA), one of the world’s largest diagnostic companies.
Clear Strategies for Growth
Miraculins has developed a clear path to market for all technologies in its pipeline.
Discovery/Aqcuisition
- Potential technology has been targeted
- Technology research is completed, ensuring all criteria met
- Intellectual Property has been secured
Research Phase
- Develop Customer Requirements
- Determine Reagents
- Determine Platform
- Develop Assay in-house
Biomarker Validation
- Experiments to Provide Confirmation Testing With Biomarkers of Interest using Independent Data
- Test the Assay to Verify Diagnostic Potential
Development Phase
- Develop the assay under cGMP requirements
- Manufacture products
Clinical Phase
- Clinical Trials
Regulatory Submission
- Preparation and Review of FDA Submissions and Other Regulated Bodies