The selection of relevant patients as candidates for targeted therapies is an indispensable component for drug development.
The Hematogenix leadership team has directly led or engaged in the development and subsequent regulatory approval of the industry’s prominent oncology companion diagnostics tests. The perspectives provided by the team come from years of experience in the diagnostic and contract manufacturing sectors. The Hematogenix team provides unique scientific development, regulatory, reimbursement and market adoption insights and is well-positioned to anticipate and mitigate the challenges of companion diagnostics development and commercialization.
Hematogenix also serves as a test site supporting PMA clinical trials for companion diagnostics devices and is also able to commercialize both pilot and regulatory companion diagnostic tests through its reference laboratory arm.
Contact us for case study testimonials for companion diagnostics such as HercepTest™, RT PCR test for BRAF mutation and the development of a FISH gene amplification assay that is currently being used for patient inclusion in several global oncology trials.
Hematogenix offers the following Companion Diagnostics services to support the pharmaceutical company and/or the diagnostic manufacturer.
Early Phase Assay Development
Hematogenix offers a comprehensive set of assay development services addressing low to high complexity conditions on various platforms. Development activity is performed according to GCP guidelines.
Late Phase Device Trial
Complete infrastructure to support conducting of a companion diagnostic device clinical trial
- Appointment of a Hematogenix device process trained principal investigator
- On site validated electronic document control process
- Customizable electronic portals for specific data transfer according to client requirements
- GCP-compliant logistics for specimen collection, study manuals and accessioning
- Digital pathology conferencing platform to coordinate training between client pathologists and Hematogenix pathologists
- Defined and customizable processes for reproducibility and proficiency testing
- Audit prepared laboratory
- Personnel trained and experienced in companion diagnostics devices clinical trials and adherence to Instructions for Use (IFUs)
Post Approval & Commercialization Support
Contact us for customized support in the following areas
- Training of commercialization teams in the diagnostics and pathology related to the companion diagnostic
- Hematogenix pathologist to pathologist consultation for implementation and workflow of the companion diagnostic
- Training and confirmatory laboratory testing for reference and hospital laboratories