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Pharma companies and diagnostic test providers are working together to ensure patients have access to targeted therapies

Companion Diagnostics Help Get Patients the Right Therapy Right Away

Pharma companies and diagnostic test providers are working together to ensure patients have access to targeted therapies

Garret Hampton, PhD

Garret Hampton is president, clinical sequencing & oncology at Thermo Fisher Scientific.

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Published:Dec 06, 2021
|3 min read
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Garret Hampton, PhD

Garret Hampton, PhD, is president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. He has over 25 years of industry experience in genomics, drug discovery, and development. Before joining Thermo Fisher Scientific, Hampton was senior vice president of clinical genomics at Illumina. Prior to his leadership roles in the clinical application of next-generation sequencing, Hampton was the global head of oncology biomarker development and companion diagnostics at Genentech/Roche, with similar roles at Celgene and Novartis Genomics Institute before that. Hampton holds a PhD in cancer genetics from the University of London. He is currently a member of the board of directors for IDEAYA Biosciences and a member of the Dean’s Leadership Council at UCSD’s School of Biological Sciences.

While the concept of personalized medicine has been around for decades, the ability to deliver truly personalized medicine at a genetic level has dramatically expanded over the last five years. In patients whose tumors have a specific genetic biomarker, a drug matched with that biomarker can be more effective and less taxing for patients than traditional first line therapies such as chemotherapy or radiation, offering an opportunity to transform delivery of care. Most targeted therapies today are developed for use in oncology and have meaningfully resulted in superior outcomes for cancer patients over the past twenty-plus years.

The U.S. Food and Drug Administration (FDA) approved the first targeted cancer therapy, tamoxifen, in the 1970s, offering an effective treatment option for patients with estrogen receptor-positive breast cancer. Since then, pharmaceutical companies have continued to develop new targeted therapies for patients with specific genetic biomarkers at an increasingly rapid pace. By 2019, more than 160 biomarkers were approved for targeted therapy selection by the FDA, with precision therapies representing up to 90 percent of the therapeutic pipeline for some major pharmaceutical companies. 

In parallel to new drug development, pharmaceutical companies and diagnostic test providers are working together to ensure more clinicians and patients have access to targeted therapies through the development of companion diagnostics. Co-developing companion diagnostic tests enables simultaneous regulatory review of a therapeutic and corresponding diagnostic to ensure that, if both are granted approval, a test is available to match patients with the new therapy as soon as the therapy is approved.

Reliable and rapid access to companion diagnostics for new therapies ensures clinicians can quickly begin testing patients’ tumor samples and putting targeted therapies to use, which can be life-changing for patients who are a match.

While single-gene testing has historically been used to test for the presence of therapy-matching biomarkers, next-generation sequencing (NGS) is quickly becoming the tool of choice for companion diagnostics.

NGS offers the ability to run one test for a variety of biomarkers simultaneously, which helps save both time and precious, often small tissue samples. Additionally, diagnostic companies are working to make this technology available to more patients through automated systems that can be easily deployed in any lab, including smaller community-based hospitals with less molecular diagnostics experience to deliver actionable results in as little as 24 hours.  

This quick turnaround time matters—research shows that if a patient does well on their first line of therapy, they typically do better overall. Around the world, there’s a much-needed effort underway to bring NGS testing closer to patients at the local level to enable faster turnaround times and broader, more equitable access to potentially life-saving therapies. Advances to technology are facilitating this shift, allowing community hospitals to provide the same rapid, high quality genomic testing results available to patients at larger academic medical centers. When available right away at hospitals everywhere, this genomic testing can unlock a world of targeted therapies for all patients.