About Our Company

We are a CAP, CLIA-certified laboratory that is designed to meet your regulatory, clinical and research requirements. A full complement of board-certified clinical, anatomic and research pathologists provide consultation and guidance for each project.

The research and clinical trials services of our Pharma Services Division are further amplified by its parent company, Hematogenix Laboratory Services (www.hematogenix.com), a comprehensive anatomic pathology reference laboratory serving oncology offices throughout the United States.

Hematogenix has the ability to “market-test” developed assays in its reference laboratory environment for important issues such as laboratory workflow, billing and reimbursement considerations. This unique feature will provide important commercialization feedback to the diagnostic manufacturer and drug developer.

Together with its parent company Hematogenix, the laboratory combination offers unique complementary perspectives. Here are some examples:

  • Hematogenix assay development incorporates clinical workflow and reimbursement requirements to position assay survivability.
  • Biomarker testing in clinical trials will address pre-analytical specimen practices that may compromise access or test quality.
  • Primary diagnoses can be confirmed through our network of expert pathologists.

Experience

The challenges in drug development require experience. Our personnel have a minimum of 10 years experience in both research and clinical applications. The following positions below will work closely with you and your team during the course of the project or clinical trial.

The Project Manager will understand the management of tissue, development of molecular assays and the logistics of drug development. Our team members will monitor timelines, respect deadlines and pro-actively communicate emerging challenges. Our project managers have direct experience with US and global clinical trials. The Project Manager will serve as your point of contact and is also responsible for handling the queries from clinical sites, CROs and third party laboratories.

Our Study Directors have extensive experience with the development of morphological and molecular assays. This individual has addressed challenging parameters stemming from pre-analytical conditions through complex image analysis based algorithms. Our Study Director’s understanding of multiple automated technologies and digital platforms will be incorporated into the Scope of Work creation for each project.

Both the Study Director and Project Manager will participate in interim updates and final summary presentations.

Hematogenix board-certified pathologists are full time employees. A Principal Pathologist and a back up pathologist will be assigned to your project. A Research Pathologist may also act as a consultant through the project. The Principal Pathologist will provide the reads for your project. Both the Principal Pathologist and the back up pathologist will be trained on the interpretation needs of the project. As required, these pathologists are available for consult and can participate in the interim updates and final presentations.

Hematogenix Scientific Team is well published in biomarker research and will accommodate requests to support and contribute to manuscripts and conference presentations.

Quality

Our lab is a GCP compliant and CAP and CLIA certified laboratory. Our laboratory workflow processes are powered by a laboratory information system selected through a rigorous process. Our system offers a thorough chain of custody, is customizable (as required) and is compliant with 21 CFR Part 11 requirements.

Detailed SOPs and experiment protocols are maintained.

Reagent, sample and operator information are recorded in SOP-specific worksheets linked to your specific project for ease in project review and sponsor audits.

Hematogenix welcomes audits from our sponsors. We request advance notice to ensure availability of relevant personnel.