In previous posts on this blog, our scientists have described the current state of precision medicine, particularly how it relates to companion diagnostics (CDx) and immuno-oncology. As an enterprise, we have been focused on this area of medicine essentially from the beginning, more than 20 years ago. LabCorp Diagnostics developed the clinical trials assay and served as the central lab for the testing of HER2-positive breast cancer during the development of trastuzumab. The company provided analytical testing data for the associated immunohistochemistry laboratory test resulting in the first companion diagnostic approved by the FDA. More recently, we were instrumental in supporting the drug development efforts for pembrolizumab, the therapy used successfully to treat former President Jimmy Carter’s melanoma, and its associated companion diagnostic.
Over the past two decades, our company has had a strong and successful track record across the development and commercialization spectrum. We have:
- Supported the development of approximately 75 percent of all FDA-approved companion diagnostics – including recent approvals for HER2, KRAS, EGRF, BRAF and ALK
- Leadership in both the in vitro diagnostics (IVD) and laboratory-developed tests (LDT) versions of companion diagnostics
- CDx experience across therapeutic areas, including oncology, cardiovascular, central nervous system, infectious disease and inflammation
- Bench to commercialization expertise in the co-development of therapeutics and accompanying CDx, including validation, testing, regulatory and market access support.
And this is only the beginning, with the market forecast for precision medicine to exceed $87 billion by 2023.[i]
The Future of Precision Medicine
The first wave of immunotherapies is making a significant difference in the medical community and for their patients, who now learn about these life-saving treatments not just from their doctors, but via such mainstream venues as television commercials, magazine ads and social media channels. The future of these novel drugs and their associated biomarker assays will involve a much deeper level of complexity. Companion diagnostics have typically targeted a single genetic or proteomic change, such as gene mutation or alteration in the structure or expression of a protein. Going forward, these tests will focus on the evaluation of multiple analytes or targets related to the biology of the disease and the specific therapeutic approach.
Newer and rapidly evolving technologies will help us pave the way for these advancements. For example, the current suite of biomarker testing for immuno-oncology includes cell-based assays, such as flow cytometry and immuno-assays; tissue-based assays that include anatomic pathology and immunohistochemistry approaches; and genomics assays that assess mutational burden, neo-antigens, immune response gene expression and microsatellite instability. At the recent American Society of Clinical Oncology (ASCO) meeting, genomic/microsatellite instability (MSI) and tumor mutation burden (TMB) were shown to be important predictors of response to immunotherapy in a pan-cancer manner. In addition, other newer technologies and applications that are already beginning to show promising results include liquid biopsy and gene expression profiling of tumor and immune function genes.
There will continue to be challenges ranging from assay development to commercialization. From a commercialization perspective, a companion diagnostic is only valuable and viable if it changes clinical practice. It has to be easy to use by the clinician and provide timely data so that doctor and patient can make decisions quickly and accurately. It also has to be affordable for the patient and cost-effective for the healthcare system.
A New Lab for a New Era
We are preparing for this increasing scientific complexity and anticipated client demand with the opening of a dedicated, state-of-the-art companion diagnostics (CDx) laboratory in Morrisville, North Carolina. This new lab space is part of a multi-use facility that also includes genomics and molecular pathology laboratories to support clinical trials and companion diagnostic assay development, as well as a nuclear magnetic resonance (NMR) laboratory that houses the first NMR spectrometer approved by the FDA to identify and quantify concentrations of lipoproteins and small molecule metabolites. Manufacturing facilities for diagnostics materials and testing components are also located on this site.
In addition, the location of the comprehensive CDx lab offers convenient access to nearby LabCorp specialty laboratories, including the Center for Molecular Biology and Pathology in Research Triangle Park and the Center for Esoteric Testing, located in Burlington. These facilities, which house many of the top researchers and scientists in their fields, create a focal point for the development and commercialization of precision medicine diagnostics.
As evidenced by our historical and current involvement, we have helped to blaze the trail for the science, regulatory support and commercialization of novel therapies and companion diagnostics. This timely and focused investment in capabilities will allow us to continue exploring new pathways for personalized treatment of some of the world’s most devastating diseases.