Let Discovery be Your Companion Diagnostic Partner
Both of the top two companion diagnostics, HER2 and PD-L1 were developed using Discovery’s advanced biomarker assay services.
June 9, 2022
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Humans are genetically diverse and full of variation. At Discovery Life Sciences we don’t shy away from this variation, we embrace it. We annotate it, we measure it, and we mine it for markers because understanding genetic variation is the gateway to understanding the molecular basis of human disease.
At Discovery we are very fortunate that we are exposed to so much variation. Variation amongst our donors, where we see cells collected from some donors having a significantly stronger therapeutic effect than cells collected from others. In our work on personalized medicine, where with our collaborators and customers we gain an understanding of how a different patient responds to a particular treatment, and which variations, or markers in their DNA can be used to predict that response across the whole population, allowing therapy to be tailored to each patient individually.
Companion diagnostics and the rise of personalized medicine
Recently, the increasing development of “omics” methods has opened up the ability for pharmaceutical companies to predict a patient’s response to treatment by measuring genetic biomarkers. These biomarkers serve to increase the efficacy of a drug by selecting only the patients for whom it will have a positive outcome from the total population of treatable patients. These companion diagnostics (CDx) can help advanced, targeted therapies such as monoclonal antibodies used to treat certain forms of cancer by increasing their efficacy, ensuring the drug reaches the required levels of safety and efficacy to succeed in clinical trials, and once in the market, ensuring that only those patients that might benefit from the drug are treated with it.
Discovery Life Sciences and the HER2 companion diagnostic
The first real example of co-development of a therapeutic drug and companion diagnostic was that of the drug Herceptin® (trastuzumab) which targets the HER2 protein. HER2 is encoded by the ERBB2 gene in humans, where overexpression of the gene or increased levels of HER2 protein are indicative of HER2-positive cancer. Typically, more aggressive than HER2 negative, these HER2 positive tumors can be effectively treated with a HER2 specific therapeutic such as Herceptin®, so long as HER2 positive patients can be identified from amongst the total patient population.
In order to guide clinical treatment decisions, the HER2 tumor test was developed as a companion to Herceptin. The companion diagnostic allowed targeted treatment of only those patients who overexpress HER2 and led to simultaneous FDA approval of both drug and diagnostic. Not only was this a massive scientific achievement, but it also paved the way for additional predictive biomarker assays to select which patients are most likely to respond during drug development. And thus, the field of companion diagnostics in personalized medicine was born. Read more about the pivotal role played by Discovery in the development of the HER2 companion diagnostic test.
Discovery Life Sciences and the PD-L1 companion diagnostic
Discovery’s contributions to the companion diagnostic field do not stop there. In fact, our team of scientists played an important role in developing an assay that laid the foundation for the successful 22C3 PD-L1 companion diagnostic. PD-L1 has been established as an essential biomarker for anti-PD-1 immune checkpoint therapies like Keytruda® (pembrolizumab). A cancer immunotherapeutic drug that blocks the PD-1 pathway, thereby boosting the immune response against cancer cells. If the companion Dx test detects a cancer patient with a tumor that expresses PD-L1, then that patient will potentially benefit from treatment with Keytruda. You can read the full case study detailing the
development of the prototype IHC assay that advanced the development and clinical application of Keytruda.
Discovery Life Science continues to work with our customers to develop biomarker assays for clinical trials and, where successful, to introduce them as clinical diagnostics in routine clinical practice. We help our customers make confident decisions with a clear understanding of their target biomarkers using Discoveries high-quality biospecimen solutions, genomic biomarker services, and an array of pathologist-driven histopathology services including IHC services delivered on all leading technology platforms (Dako, Ventana, Leica, TechMate). We understand that navigating the path to develop a companion diagnostic can be challenging. If it’s something your organization is considering, doesn’t it make sense to partner with someone who has been there before? A partner who has worked on both of the most significant companion diagnostic assays to date, and whose experience in companion diagnostics stretches back more than two decades. Contact us here to learn how Discovery can help you with your next project.
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