About Canopus Biosciences Ltd.

Canopus Bioscience develops instrumentation and methodologies that are focused on the goal of improving patient-specific diagnostics and disease management. More information is available at www.canopus-bioscience.com

About Pathway Diagnostics

Pathway Diagnostics develops and commercializes novel, proprietary biological markers. The company in-licenses proprietary biomarkers, develops them into validated assays, offers the assays as part of its clinical trials testing service, and commercializes them as diagnostic tests in partnerships with leading diagnostics manufacturers and national laboratories. More information is available at www.pathwaydx.com.

Canopus Bioscience ltd.

Circulating Tumor Cell Platform Technology

CTC (Circulating Tumor Cell) technology (patent pending) is an enabling platform technology for the recovery and analysis of disseminated cancer cells in peripheral blood. Capitalizing on recent advances in disease marker discovery, single cell analysis, and patient-specific therapeutics our CTC technology provides a high sensitivity, high specificity, repeatable, reproducible, and non-invasive diagnostic assay for guiding treatment decisions and improved patient triage.

Tumor Cells Retrieved By Canopus Bioscience's CTC Enrichment Technology    More details and larger magnification.

Background

Clinical research on a range of cancer types has demonstrated that the presence and number of CTCs is a useful diagnostic indicator of metastatic potential. Recent literature suggests that tumor cells may disseminate in a far less progressed genomic state than what was previously thought, only later acquiring genomic aberrations typical of metastatic cells. The early detection followed by early treatment of cancer equates to an improved survival and decreased morbidity. Our CTC technology when combined with immunochemical staining for disease-specific markers provides a powerful diagnostic indicator for patient-tailored treatment. An example is the detection of Her2neu over-expression indicating an aggressive but potentially treatable form of breast cancer. 

Moreover, the Canopus CTC technology can be applied to treatment monitoring by repeat sampling and enumeration of the CTC burden in patient blood samples.

CTC Process Our enrichment process removes all the red blood cells and reduces the number of white blood cells (leukocytes) to nominally 50,000 cells (1000:1 enrichment) for 4-5ml of blood. The enriched sample can then either be presented as a single mono-layer slide or fed through an imaging flow cytometer.

Benefits of Our Technology

The CTC technology produces an enriched specimen that maintains cell morphology and is compatible with any immunocytochemical staining technique.  It can also be coupled with complementary technologies, leveraging recent advances made in disease marker discovery, single cell analysis, and patient-specific therapeutics. Currently, Canopus has demonstrated effectiveness with non-specific cancer markers and with markers specific to breast cells.  This enabling technology bridges a crucial gap between patient-specific disease etiology and patient-tailored treatment options.  

Additional benefits:

• High sensitivity (greater than 80% tumor cell recovery based on cell seeding studies)
• Minimally invasive to the patient, requiring only a small 4 ml blood sample
• High specificity (no false positives)
• Compatible with both slide-based cytochemical detection and single cell molecular analysis
• No false positives
• Gives a quantitative and readily visible result suitable for automated or manual review
• Low cost per test
  
• Amenable to automation for test reproducibility

Limitations of Alternative Technologies

Molecular diagnostic products have limitations that restrict their widespread market acceptance:

• Complex procedures that are difficult to automate, require highly trained lab technicians and specialized instruments
• High cost – expensive diagnostic kit and high labor cost
• Low and irreproducible recovery 
• Prohibitively long running time; not scalable to larger volumes
• Detection technologies that rely on immuno-based selection are limited by the complex blood matrix that can sequester and remove CTCs
• Blood proteins are known to coat cancer cells in circulation preventing recognition by immuno-based selection methods 
• Molecular analysis for CTCs in non-enriched mononuclear cell fractions is often associated with increased false positive results
  

Market Background

The push to develop targeted therapies is the most notable trend in oncology since the introduction of cell-killing treatments. A significant number of cell-specific and patient-specific therapies have reached late-phase trials and have even been marketed (e.g. Gleevec® and Herceptin®), raising expectations that similar treatments can play a major role in cancer care. However, major challenges remain in target definition and patient selection. To address these challenges, many targeted drugs will require cell-specific biomarker-based diagnostic tests. Consequently, it is anticipated that the theranostic market, or therapeutics coupled to specific diagnostic tests, will achieve significant growth in the coming years.

Recently Veridex a J&J company received a 510k for what in the past was considered by FDA to be a Class III device. This has significantly reduced the cost of entry into the market! The resulting test for the management of metastatic breast cancer is estimated to have a $300 million per year market value.

Target Cancers

In general, any tumor types that disseminate cells into the bloodstream are good candidates for both detection and disease monitoring. These include breast cancer, malignant melanoma, prostate cancer, lung cancer, gastrointestinal cancers and pancreatic cancer.

Of special interest:

• Cancers that are hard to detect by conventional diagnostic examination and imaging techniques (e.g. pancreatic cancer)
• Diseases associated with high-risk populations (e.g. smokers, hereditary mutations in BrCa1/2, melanoma sufferers)
• Cancers that often display multi-drug resistance during disease management
• Lung cancer because of the difficulty of obtaining an adequate sputum sample
• Cervical cancer because of examination discomfort

Canopus Bioscience welcomes inquiries from potential research, licensing or marketing partners.       For additional information please email: corporate@canopus-bioscience.com