Thermo Fisher Scientific is your trusted partner for precision medicine development
As your partner, we can help you...
with our subject matter expertise as proven by our FDA-granted de novo HLA typing CDx assay as well as our clinically proven HLA typing and antibody screening platforms.
in clinical trial assay management with our proven HLA CDx co-development solutions.
with wide-range CDx assay distribution, testing, training, support, and post-market surveillance through our Global Commercialization and Support networks.
Precision medicine aims to tailor medical decisions and treatment based on the individual characteristics of each patient. As part of precision medicine, Companion Diagnostics tests (CDx) play an important role in providing information essential for the safe and effective use of a corresponding therapeutic product, such as a drug or biologic, based on effect biomarker association.
What is HLA?
Human leukocyte antigen (HLA) genes, also known as major histocompatibility complex (MHC), are the most polymorphic region of the human genome. These expressed molecules play an integral role in the adaptive immune response by presenting peptides to T cells to activate the immune response. In malignant cells, HLA molecules present neo-antigens from tumor mutations to activate lymphocytes to eliminate tumor cells.
What is the role of HLA in Companion Diagnostics?
Given the role of HLA molecules in activating the immune response, they become natural targets as potential biomarkers, especially in the immunotherapy space where HLA typing is becoming relevant to identify patients who benefit from a given therapy, creating a need for HLA CDx development opportunities.
Thermo Fisher Scientific has nearly 40 years of expertise in HLA diagnostic testing. We provide a comprehensive HLA typing and antibody screening product portfolio, including the first de novo classification of HLA typing CDx granted by the FDA.
The drug development process is complex, time-consuming and costly. The co-development of CDx can reduce drug development time, streamline clinical trials, and accelerate regulatory approvals and time to market. With a global regulatory team across Thermo Fisher Scientific and a proven track record in diagnostic and companion diagnostic development, we have established processes for all aspects of CDx co-development that involve coordinated efforts with pharmaceutical manufacturers, contract research organizations and regulatory bodies.