Supporting the Implementation of Precision Medicine.
Precision Rx-Dx Inc. is an international consultancy, based in Canada, formed to support companies during launch of their Precision Medicines and the associated biomarkers.
Providing deep expertise to adapt regional strategies for companion diagnostics and biomarkers to optimize launches of precision medicines
Our focus is to provide consultation and support to our clients in refining their global strategies as well as building local market and organizational readiness. Our team of experts have an extensive knowledge of the CDx and biomarker landscape and the rapidly evolving policies and practices.
This ensures a robust launch and accelerated adoption of both the targeted therapeutic and the associated biomarker.
I wanted to extend our sincere thanks regarding the high quality of the content within the syndicated report and the time in which your team was able to turn it around. There are a number of tremendously helpful data points within the report, which will impact our strategic approach, and which shed light on some key unanswered questions we had had. Thank you to you and your team for your hard and thorough work. It is always a pleasure working with the Precision Rx-Dx team.
Providing Best-Practice Biomarker launch expertise from strategy development to hands-on test implementation support
Precision’s programs are developed to address the multidisciplinary requirement of this field and we are very experienced in facilitating dialogue and stakeholder collaboration to manage change in the marketplace.
Many of Precision’s programs culminate in the development of best practice publications, including clinical and testing algorithms for new companion diagnostics and biomarkers.
Expert "turn-key" support and Best-Practice Biomarker test launch expertise
Providing biomarker implementation support concurrent with the launch milestones of the therapy
Drug Development and Launch Milestones
Phase II or III
Therapy
Regulatory Approval
Therapy
HTA* Submission
Therapy HTA +ve
recommendation
Jurisdiction Test
Submission, Evaluation
RX/Test Funding
Decision
*HTA = Health Technology Assessment
Precision Rx-Dx Test Implementation Support
Biomarker-Precision
Medicine Strategy
Market Readiness
to Standard of Care
Reimbursement
- Corporate Education programs
- Support Strategic planning
- Advisory and Landscape Research
- Technology and Lab Capability Audits
- Clinical and Test Guidance through algorithms and best practices
- Outcomes applied for publications and education programs
- Test Implementation support to ensure testing readiness at key regulatory and launch milestones
- Identify funding and influence pathways to facilitate biomarker funding
- Corporate Education programs
- Support Strategic planning
- Advisory and Landscape Research
- Technology and Lab Capability Audits
- Clinical and Test Guidance through algorithms and best practices
- Outcomes applied for publications and education programs
- Test Implementation support to ensure testing readiness at key regulatory and launch milestones
- Identify funding and influence pathways to facilitate biomarker funding
Differentiated Biomarker Capabilities to Support Our Clients
| Capability |  | Regional Client In-house Expertise* | Pharma Services | Small Niche Pharma Companies |
|---|---|---|---|---|
| Proven end-to-end biomarker consulting expertise | ||||
| Strong regional client relationships | ||||
| Established network and reputation | ||||
| Demonstrated depth/breadth of biomarker experience | ||||
| Robust, customizable Rx-Dx processes |
* Region and client-dependent
Precision Rx-Dx
- Proven end-to-end biomarker consulting expertise
- Established network and reputation
- Demonstrated depth/breadth of biomarker experience
- Robust, customizable Rx-Dx processes
Regional Client In-house Expertise*
- Proven end-to-end biomarker consulting expertise
- Established network and reputation
- Demonstrated depth/breadth of biomarker experience
- Robust, customizable Rx-Dx processes
Pharma Services
- Proven end-to-end biomarker consulting expertise
- Established network and reputation
- Demonstrated depth/breadth of biomarker experience
- Robust, customizable Rx-Dx processes
Small Niche Pharma Companies
- Proven end-to-end biomarker consulting expertise
- Established network and reputation
- Demonstrated depth/breadth of biomarker experience
- Robust, customizable Rx-Dx processes
* Region and client-dependent
Specialized Expertise to Support Our Clients
Seasoned experts in diagnostic and/or pharmaceutical development, and clinical laboratory testing for predictive biomarkers
Covering the Following Areas
- Precision medicine and biomarker education and program management
- Education and consultation service on reimbursement
- Strategic, scientific, and diagnostic advice and consultation
- Medical writing for scientific publications
- Hands-on biomarker implementation support (diverse molecular and expression assays)
Example Roles within the Team
Leadership
-
Monette Greenway, BSc., C. Dir.
Principal and Co-Founder
Educated in genetic engineering and biotechnology, Monette’s career has centered on the development and successful market adoption of life science and diagnostic innovation. Monette has lived and worked internationally with growth mandates in the pharma biomarker development area, and hospital and community lab sectors. With over 25 years of executive experience her past roles include global President/Vice President positions with Thermo Fisher Scientific and Executive Commercial/Government relations’ roles with LifeLabs Medical Laboratories, Strategic Diagnostics and Mount Sinai Services.
-
Ann Humphreys, BSc., MBA.
Principal and Co-Founder
Ann has over 30 years of executive experience in the healthcare industry and brings hands-on market launch expertise and knowledge across many therapeutic and diagnostic categories. Ann started her career with J&J at Ortho Diagnostics here in Canada and was responsible for the development and launch of new diagnostic products both in Canada and internationally. Her extensive pharmaceutical experience includes her role on the Executive Management Board of Janssen-Ortho as VP Marketing and Sales, Biotech/Oncology and New Product Development. Ann was responsible for the launch of many speciality therapeutics products.
Published in Leading Journals Including
Reports and Publications
For over 10 years Precision Rx-Dx has facilitated change to support access and adoption of new Predictive Biomarkers.
Our bespoke process assists with clinical test implementation and has also resulted in multi-disciplinary pan-Canadian or jurisdictional consensus recommendations or guidelines. The reports and publications span diverse indications in oncology and hematology with biomarker capabilities and experience related to both molecular and immunohistochemistry test launches.
For more information regarding our syndicated reports please contact us.
View Recent Publications & Guidelines
- Brezden-Masley, C.; Fiset, P.O.; Cheung, C.C.; Arnason, T.; Bateman, J.; Borduas, M.; Evaristo, G.; Ionescu, D.N.; Lim, H.J.; Sheffield, B.S.; et al."Canadian Consensus Recommendations for Predictive Biomarker Testing in Gastric and Gastroesophageal Junction Adenocarcinoma"Current Oncology
- Mete, O., Boucher, A., Schrader, K.A. et al."Consensus Statement: Recommendations on Actionable Biomarker Testing for Thyroid Cancer Management"Endocr Pathol (2024)
- Rendon RA, Selvarajah S, Wyatt AW, et al."2023 Canadian Urological Association guideline: Genetic testing in prostate cancer"Can Urol Assoc J 2023; 17(10): 314-25
- Black, P. C. et al."Optimizing management of advanced urothelial carcinoma: A review of emerging therapies and biomarker-driven patient selection."Can Urol Assoc J., E373-E382
- Cheung, C. C. et al and Canadian Association of Pathologists-Association Canadienne Des Pathologistes' National Standards Committee for High Complexity (2019)"Fit-For-Purpose PD-L1 Biomarker Testing For Patient Selection in Immuno-Oncology: Guidelines For Clinical Laboratories From the Canadian Association of Pathologists-Association Canadienne Des Pathologistes (CAP-ACP)."Appl Immunohistochem Mol Morphol 27(10): 699-714
- Stockley, T. et al."Evidence-based best practices for EGFR T790M testing in lung cancer in Canada."Curr Oncol 25(2): 163-169
- Torlakovic, E., et al."“Interchangeability” of PD-L1 immunohistochemistry assays: a meta-analysis of diagnostic accuracy."Mod Pathol, 4-17
- Cheema, P., et al."Consensus Recommendations for Optimizing Biomarker Testing to Identify and Treat Advanced EGFR-Mutated NSCLC."Curr Oncol 27(6)
- Tierens, A., et al."Consensus Recommendations for MRD Testing in Adult B-Cell Acute Lymphoblastic Leukemia in Ontario"Curr. Oncol. 28(2), 1376-1387
- Ionescu, D., et al."Consensus Recommendations to Optimize Testing for New Targetable Alterations in Non-Small Cell Lung Cancer"Curr. Oncol. 29(7), 4981-4997
- Selvarajah, S., et al"Recommendations for the implementation of genetic testing for metastatic prostate cancer patients in Canada"CUAJ 2022, 16(10)
Contact us
We are committed to responding promptly and efficiently to your needs.
- info@precisionrxdx.com
- Address
- Toronto, ON