GRAIL Initiates the STRIVE Study to Advance Development of Blood Tests to Detect Cancer Early

Large-scale study to enroll up to 120,000 women; initial collaborators include Mayo Clinic and Sutter Health

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| Source: Grail, Inc.

MENLO PARK, Calif., April 20, 2017 (GLOBE NEWSWIRE) -- GRAIL, Inc., a life sciences company whose mission is to detect cancer early when it can be cured, today announced that it has commenced its second multi-center clinical study, the STRIVE Study, to facilitate the development of GRAIL’s blood tests for early-stage cancer detection. STRIVE is a longitudinal, prospective, observational study that will enroll up to 120,000 women at the time of their screening mammogram to train and validate a blood test to detect breast cancer. Additionally, the study will be used to develop a pan-cancer test to detect multiple cancers at early stages.

“Breast cancer that is detected early can be treated more effectively. GRAIL aims to develop a blood test to enhance existing methods of breast cancer screening, with the goal of improving patient outcomes by more accurately identifying patients who need further evaluation for cancer,” said Mark Lee, M.D., Ph.D., GRAIL’s Head of Clinical Development and Medical Affairs. “We are committed to developing a deep understanding of cancer biology and rigorously evaluating our tests for validity and utility through large studies such as STRIVE.”

The STRIVE Study will enroll women at Mayo Clinic and throughout the Sutter Health system that serves Northern California, and will collect baseline blood samples from women at the time of their screening mammogram.

“Breast cancer is the most common cancer in women in both developed and less developed countries around the globe. Despite many medical and therapeutic advances in treatment, approximately 40,000 women in the U.S. will die from breast cancer this year and many others will require treatment for advanced disease,” said Steven Cummings, M.D., Professor of Medicine and Epidemiology & Biostatistics (Emeritus), UCSF, and Senior Scientist, California Pacific Medical Center Research Institute, Sutter Health. “I am excited to be part of this initiative to apply new technology to the possibility of detecting breast cancer, and other cancers, at earlier stages.”

“In order to develop and validate a blood test for the early detection of breast cancer, we need the participation of up to 120,000 women. GRAIL’s cutting-edge clinical technology enables us to enroll at scale and speed while collecting high-quality clinical outcomes data,” said GRAIL’s Head of Clinical Development, Anne-Renee Hartman, M.D. “We are extremely honored to work with Sutter Health and Mayo Clinic on this endeavor and are thankful for the centers and participants who make this study possible.”

The STRIVE Study is one of several studies that GRAIL plans to initiate over the next few years. In December 2016, GRAIL announced its first multi-center clinical study, the Circulating Cell-free Genome Atlas (CCGA) (CCGA) study to characterize the landscape of cell-free nucleic acid profiles in individuals with cancer and in non-cancer participants using GRAIL’s “high-intensity” sequencing approach. Mayo Clinic is one of the main academic sites for the CCGA study, and Dr. Minetta Liu, who is a Principal Investigator for STRIVE, serves on the CCGA Scientific Advisory Board. GRAIL intends to conduct additional studies that, in aggregate, will enroll hundreds of thousands of participants, in order to achieve its mission of detecting cancer early, when it can be cured.

About the STRIVE Study
The STRIVE Study is a prospective, multicenter, observational study of 120,000 women undergoing screening mammography. The purpose of the STRIVE Study is to train and validate a test for detection of breast cancer. The cohort will also be utilized to train and develop a pan-cancer test. The STRIVE Study will include medical centers throughout the Sutter Health system that serves Northern California, and Mayo Clinic. Mayo Clinic locations include Rochester, Minnesota; Jacksonville, Florida; and Phoenix, Arizona; as well as the Mayo Clinic Health System Franciscan Healthcare locations in La Crosse and Onalaska, Wisconsin.

The Mayo Clinic Principal Investigators are Minetta Liu, M.D.,  Associate Professor of Oncology, Celine Vachon, Ph.D., Professor of Epidemiology, and Fergus Couch, Ph.D., the Zbigniew and Anna M. Scheller Professor of Medical Research, with support from the Mayo Clinic Center for Individualized Medicine and the Mayo Clinic Cancer Center. The Sutter Health Principal Investigator is Steven Cummings, M.D., F.A.C.P., Professor of Medicine and Epidemiology & Biostatistics (Emeritus), UCSF, Senior Scientist, CPMC Research Institute, Sutter Health. Karla Kerlikowske, M.D., Professor of Medicine and Epidemiology & Biostatistics, UCSF, is also a Principal Investigator.

More information about the STRIVE Study can be found at NCT03085888.

About GRAIL’s High-intensity Sequencing Approach
GRAIL’s approach is to sequence circulating nucleic acids at unprecedented breadth and depth to optimize the detection of early-stage cancer. Combined with one of the largest clinical trial programs ever pursued in genomic medicine, GRAIL will be creating datasets of unprecedented scale to enable the deepest and most comprehensive understanding of cancer biology. GRAIL’s technology infrastructure teams are at the forefront of modern practice in developing and deploying scalable, cloud-based databases and analysis engines. GRAIL will apply such methods to all steps of the Company’s data-generating pipeline including the ultimate challenge of classifying patients according to the presence, type, and severity of cancer. From the laboratory to the clinic, GRAIL’s goal is to produce the highest quality data and transform them into clinically actionable insights to save lives.

About GRAIL
GRAIL is a life sciences company whose mission is to detect cancer early when it can be cured. GRAIL is using the power of high-intensity sequencing, population-scale clinical trials, and state of the art Computer Science and Data Science to enhance the scientific understanding of cancer biology and develop blood tests for early-stage cancer detection. The company has secured over $1B in venture funding led by ARCH Venture Partners and including Amazon, Bezos Expeditions, Bill Gates, Bristol-Myers Squibb, Celgene, GV, Illumina, Johnson & Johnson Innovation, Merck, McKesson Ventures, Sutter Hill Ventures, Tencent, Varian Medical Systems, and other financial partners. For more information, please visit www.grail.com.

GRAIL Contact:
Denise Powell
510.703.9491


Mayo Clinic Contact:
Susan Buckles
507.284.5005


Sutter Health/CPMC Contact:
Dean Fryer
415­.580­.5654