Grail gets FDA breakthrough designation for multi-cancer test

15 May 2019 (Last Updated May 15th, 2019 10:18)

Healthcare company Grail has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its blood test being developed to detect multiple cancer types in people aged 50 years and above.

Grail gets FDA breakthrough designation for multi-cancer test
Grail is developing a methylation blood test to detect multiple cancer types. Credit: 10918156 from Pixabay.

Healthcare company Grail has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its blood test being developed to detect multiple cancer types in people aged 50 years and above.

The first pre-planned sub-study of the company’s Circulating Cell-free Genome Atlas (CCGA) study demonstrated that its three prototype next-generation sequencing (NGS) tests could identify various cancers using a single blood draw.

“There are no effective early detection tests for the majority of cancer types.”

These tests showed a low rate of false positive results, indicating high specificity.

Grail has selected methylation as its preferred method and devised a methylation sequencing blood test targeting the most informative genome regions. The test leverages machine learning algorithms to detect the presence of cancer as well as identify the tissue of origin.

Currently, the methylation test is undergoing the second pre-planned sub-study of CCGA. New study results will be presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.

The data is set to include findings on the methylation technology’s ability to identify the tissue of origin when cancer is present.

Grail CEO Jennifer Cook said: “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.

“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.”

The company is conducting a clinical research programme comprising three large-scale studies that will involve around 165,000 participants to develop an atlas of genomic cancer signals in the blood.

In addition, the studies are meant for assessing the blood test for the early detection of multiple cancer types. Till date, around 115,000 participants have been recruited.