Therapy Areas: Respiratory
GrailTouts Positive New Data with Multi-Cancer Early Detection Blood Test from CCGA Study
31 May 2019 - - US-based Grail, Inc., a healthcare company focused on the early detection of cancer, has released new data from the Circulating Cell-free Genome Atlas study that demonstrates the ability of Grail's technology to detect cancer early with a single blood test, the company said.
Data showed Grail's investigational multi-cancer blood test detected a strong signal for 12 deadly cancer types at early stages with a very high specificity of at least 99% (or a false positive rate of 1% or less).
In addition, the test identified where the cancer originated in the body (the tissue of origin) with high accuracy.
Detection rates (sensitivity) for the 12 deadly cancer types ranged from 59 to 86% at early stages (stages I-III).
A combined analysis of this group of cancers showed robust detection at early stages (34%, 77%, and 84% at stages I, II, and III, respectively).
In addition, a tissue of origin result was provided for 94% of all cancers detected and, of these, the test correctly identified the tissue of origin in 90 % of cases.
The 12 pre-specified cancer types included anorectal, colorectal, esophageal, gastric, head and neck, hormone receptor negative breast, liver, lung, ovarian, and pancreatic cancers, as well as multiple myeloma and lymphoid neoplasms.
Together, these cancer types account for approximately 63% of all cancer deaths in the United States.
These data will be presented in a poster tomorrow, Saturday, June 1 at the 2019 American Society of Clinical Oncology annual meeting by Minetta Liu, MD, Research chair and Professor, Department of Oncology, Mayo Clinic (Abstract 3049).
In the second pre-planned case-control sub-study of CCGA, Grail's multi-cancer early detection blood test is being evaluated in approximately 4,500 participants for its ability to detect cancer and identify the tissue of origin when cancer is present.
Data reported at ASCO are based on an initial analysis of 2,301 participants from the training phase of the sub-study, including 1,422 participants with more than 20 cancer types across all stages and 879 participants without diagnosed cancer.
This sub-study is ongoing, and the company is planning to present additional results at future medical conferences.
All results are reported at 99 % specificity, which equates to a false positive rate of 1%. The actual false positive rate may be less than 1%, since cancer incidence rates suggest some of the individuals enrolled in the non-cancer group may have had an undiagnosed cancer at enrollment.
Follow-up of participants in CCGA is ongoing, and outcomes will be collected for five years.
The overall detection rate for more than 20 cancer types in the sub-study across all stages was 55% (n=784/1,422; 95% confidence interval: 52.5-57.7%).
A tissue of origin result across more than 20 cancer types was provided for 94% of all cancers detected by GRAIL's test (n=735/784), and of these, the test correctly identified the tissue of origin in 90% of cases (n=663/735).
The overall detection rate for the 12 pre-specified deadly cancer types across all stages was 76 % (n=671/882; 95% confidence interval: 73-79%). The tissue of origin accuracy for this group of cancers was consistent regardless of stage ranging from 84 to 92 %.
The Circulating Cell-free Genome Atlas study is a prospective, observational, longitudinal, case-control study that has completed enrollment of approximately 15,000 participants with and without cancer across 142 sites in the United States and Canada.
CCGA is designed to characterise the landscape of genomic cancer signals in the blood and to discover, train, and validate Grail's multi-cancer early detection blood test through three pre-planned sub-studies.
Grail is developing a next-generation sequencing blood test for the early detection of multiple deadly cancer types. Grail's high efficiency methylation-based technology preferentially targets the most informative regions of the genome and is designed to use its proprietary database and machine-learning algorithms to both detect the presence of cancer and identify the tumor's tissue of origin.
Grail's sequencing database of cancer and non-cancer methylation signatures is believed to be the largest of its kind and covers approximately 30 m methylation sites across the genome. More than 20 cancer types across stages are represented within the database.
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.
Login
Username:

Password: