Entering a New Era of Early Cancer Detection
Josh Ofman, MD, MSHS, Chief Medical Officer and External Affairs | May 28, 2020

GRAIL’s blood-based multi-cancer detection test continues to advance since achieving a major milestone at last year’s ASCO Meeting

For 45 years, the American Society of Clinical Oncology (ASCO) Annual Meeting has provided an opportunity to chart progress in the fight against cancer. Marked in its early days by steady advancements in chemotherapy and a growing understanding of cancer as a disease of the genome, in recent decades the meetings have witnessed the dramatic emergence of targeted treatments and immunotherapies. Yet despite the tremendous advancements made in oncology, more than 1,600 people die in the U.S. every single day, and cancer is soon to be the world’s number one killer. A “new front” in the war on cancer has been summoned — multi-cancer early detection.

At last year’s ASCO, we presented data from our foundational study, the Circulating Cell-free Genome Atlas (CCGA) Study, which we view as the foundation for a groundbreaking development in cancer control. This is the largest study of its kind, grounded in the principles of precision medicine and leveraging technological advances in genomics and machine learning, GRAIL reported results from CCGA demonstrating that a single blood test can detect more than 50 cancers.

The ASCO presentation was a major milestone because it suggested our test could enable the routine identification of many more cancers, and at early stages, when therapies are much more likely to be successful, and even curative. For example, a person whose cancer is found before it has spread to other parts of the body is more than four times as likely to survive five years than a person diagnosed with advanced disease.

The unmet need for early cancer detection is significant. In fact, the five cancers with existing screening recommendations in the U.S. today represent less than 50 percent of the cancers in individuals 50 to 79 years of age. And while current screening critically improves cancer outcomes, it alone is not enough. According to our estimates, nearly 80 percent of cancer deaths are attributable to cancers with no recommended screening tests.

Fortunately there are companies and institutions making tremendous progress in the rapidly emerging technology of multi-cancer early detection. There are recent data suggesting multi-step approaches — like a series of blood tests, followed by a diagnostic PET-CT scan — can help find cancer. And we at GRAIL are employing a single blood test, and are dedicated to making the revolutionary breakthrough of safe and effective multi-cancer early detection a reality.

GRAIL’s test was designed to maximize population cancer detection while minimizing potential harms, and is a complement to existing screening tests. GRAIL’s test can detect more than 50 cancers across all stages, with a very low false positive rate of less than one percent. When a cancer signal is detected, our test can identify where in the body the cancer is located with high accuracy — critical to enable health care providers to direct efficient work-up and subsequent care for patients. Recent modeling data suggests if all cancers currently diagnosed at stage IV could be detected earlier, evenly distributed across stages I-III, cancer deaths could fall by 24 percent.

This is what motivates us to continue to advance our technology. We are building the foundation of evidence necessary for clinical use and broad adoption. In the last year, we made tremendous progress in advancing our mission. In addition to multiple data presentations, we published validation data for our test in Annals of Oncology, and we initiated PATHFINDER, an interventional study that will use the test to guide clinical care for the first time. This large-scale interventional study is being conducted at Dana-Farber Cancer Institute, Mayo Clinic, Intermountain Healthcare, Sutter Health, Oregon Health & Science University, and Cleveland Clinic.

GRAIL was founded to tackle one of the most ambitious undertakings in healthcare, to find cancer early, when it can be cured. We knew the path would not be easy because this groundbreaking technology would be the first of its kind. What we have set out to do is change the trajectory of cancer care, and we are on the cusp of making this a reality. Beating cancer starts with knowing you have it, and GRAIL’s novel approach to early detection could provide a potent new weapon in the war against cancer.

We are grateful for our scientific advisors, investigators, and clinical study participants who propel us in this journey.

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