GRAIL Announces Significant Progress with Multi-Cancer Early Detection Test Including FDA Breakthrough Device Designation

— Proprietary Methylation Technology Selected for Continued
Development of Multi-Cancer Test —

— CCGA and STRIVE Studies Fully Enrolled with Approximately 115,000
Participants; Enrollment Initiated in 50,000-Participant SUMMIT Study —

— New Data from CCGA to be Presented at 2019 American Society of
Clinical Oncology Annual Meeting —

MENLO PARK, Calif.–(BUSINESS WIRE)–GRAIL, Inc., a healthcare company whose mission is to detect cancer
early, when it can be cured, today announced that its multi-cancer 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. 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.

“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,” said Jennifer Cook, Chief Executive Officer. “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.

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.

About GRAIL’s Clinical Program

GRAIL is conducting what the company believes to be one of the largest
clinical research programs ever pursued in genomic medicine. The program
consists of three large-scale studies designed to enroll approximately
165,000 participants to create an atlas of genomic cancer signals in the
blood, and to develop and evaluate GRAIL’s blood test for the early
detection of multiple cancer types. Approximately 115,000 participants
have been enrolled to date.

The CCGA study is a prospective, observational, longitudinal study that
has completed enrollment of approximately 15,000 people with and without
cancer across 142 sites in the United States and Canada. GRAIL is
conducting three pre-planned sub-studies within CCGA to discover, train,
and validate its multi-cancer early detection test.

The STRIVE study is a prospective, observational, longitudinal cohort
study that has completed enrollment of approximately 100,000 women at
the time of their screening mammogram across 37 sites in the United
States. STRIVE is designed for clinical validation of GRAIL’s
multi-cancer test in an intended use population. GRAIL anticipates
reporting data from STRIVE in 2020.

The SUMMIT study is a prospective, observational, longitudinal cohort
study that is enrolling participants in London in the United Kingdom.
The study is designed to enroll approximately 50,000 men and women who
do not have a cancer diagnosis at the time of enrollment. Approximately
half of the participants will be people at high risk of lung and other
cancers due to a significant smoking history, and the other half will be
people who are not at high risk for cancer based on smoking history.
SUMMIT is designed for clinical validation of GRAIL’s multi-cancer test
in a second intended use population and to evaluate clinical utility of
the test in a high-risk population.

About GRAIL’s Methylation Technology

GRAIL is developing an NGS blood test for the early detection of
multiple deadly cancer types. GRAIL’s methylation technology
preferentially targets the most informative regions of the genome and
uses machine-learning algorithms to both detect the presence of cancer
and identify the tumor’s tissue of origin when cancer is present.

DNA methylation is a natural process used by cells to regulate gene
expression. It is a chemical modification to DNA and a well-studied
epigenomic feature of the genome. In cancer, abnormal methylation
patterns and the resulting changes in gene expression can contribute to
tumor growth. For example, hypermethylation can cause tumor-suppressor
genes to be inactivated.

About GRAIL

GRAIL is a healthcare company whose mission is to detect cancer early,
when it can be cured. GRAIL is focused on alleviating the global burden
of cancer by developing pioneering technology to detect and identify
multiple deadly cancer types early. The company is using the power of
next-generation sequencing, population-scale clinical studies, and
state-of-the-art computer science and data science to enhance the
scientific understanding of cancer biology, and to develop its
multi-cancer early detection blood test. GRAIL is located in Menlo Park,
California. It is supported by leading global investors and
pharmaceutical, technology, and healthcare companies. For more
information, please visit www.grail.com.

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

Contacts

GRAIL
Charlotte Arnold
650-255-1909
[email protected]