GRAIL, Inc., announced that its multi cancer early detection test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The investigational blood test is in development for the early detection of multiple cancer types in individuals aged 50 or older.
Grail reports that the FDA grants Breakthrough designation to devices that have the potential to provide for more effective diagnosis of life-threatening diseases such as cancer. The goal of the FDA’s Breakthrough Devices Program is to provide patients and healthcare providers with timely access to medical devices granted the designation by speeding up their development, assessment, and review.
Jennifer Cook, Chief Executive Officer of Grail reported, “We’re excited the FDA recognizes the potential of our multi-cancer early detection blood test. There are no effective early detection tests for the majority of cancer types, and many deadly cancers are often detected too late. We hope our test may offer a chance to address these challenges.” Cook added, “We have made significant progress developing our multi-cancer test and look forward to sharing new data at ASCO and other medical conferences this year.”
GRAIL previously reported data from the first pre-planned sub-study of its Circulating Cell-free Genome Atlas (CCGA) study, which showed that its three prototype next-generation sequencing (NGS) blood tests were able to detect multiple deadly cancer types from a single blood draw, with a low rate of false positive results (high specificity).1 The company has since selected methylation as its preferred approach and has developed a methylation sequencing blood test that preferentially targets the most informative regions of the genome to both detect the presence of multiple types of cancer and identify the tissue of origin (the part of the body where the cancer originated). The blood test is currently being evaluated in the second pre-planned sub-study of CCGA.
In addition new results from CCGA will be presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting, including data on the ability of the company’s methylation technology to identify the tissue of origin when cancer is present. An analysis of survival of participants whose cancer was detected by the methylation technology, compared with those whose cancer was not detected by the technology, will also be presented.
1 Klein EA et al., J Clin Oncol. 2018;36 (suppl; abstr 12021); https://grail.com/wp-content/uploads/2018/09/ASCO_2018_CCGA-Multi-Cancer_Klein_POS_Final.pdf