Cancer diagnostics venture GRAIL has been granted an FDA breakthrough device designation for its lead multi-cancer detecting blood test.
Grail is a spin-out of genome sequencing giant Illumina, and is leveraging the whole genome sequencing (WGS) power of its parent company with the goal of revolutionising cancer diagnostics.
The FDA breakthrough status is a major milestone for the technology, which is currently in the development stages. It has already shown that it can detect multiple deadly cancer types from a single blood sample, with a low rate of false positive results, but the company is now undertaking long-term real world studies to prove its efficacy.
Unlike existing tests, Grail’s technology is based on vast amounts of tumour genome data which it obtains through high-intensity gene sequencing.
Grail’s sequencing test is built on the methylation approach, whereby it targets the most informative regions of the genome to detect the presence of multiple types of cancer and identify its origin.
While there are numerous cancer diagnostic tests on the market, the focus is currently on identifying a tumour subtype after diagnosis, rather than achieving an early, primary diagnosis via a blood test.
If Grail gets the go-ahead for the tool it could help shift cancer therapy to much earlier diagnosis, which would help overall survival, and possibly help avoid expensive oncology treatment downstream.
Jennifer Cook
“We’re excited the FDA recognises 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 Grail’s CEO, Jennifer Cook.
“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’s STRIVE study is a prospective, observational, longitudinal cohort study that has completed enrolment of around 100,000 women at the time of their screening mammogram across 37 sites in the US. The trial is designed for clinical validation of GRAIL’s multi-cancer test in an intended use population, and the company anticipates reporting data from STRIVE in 2020.
The test is also being evaluated in the second sub-study of Circulating Cell-free Genome Atlas (CCGA), which the company claims is one of the largest clinical research programmes ever pursued in genomic medicine.
The results gathered from this trial will be used to inform, further develop and evaluate the blood test for early detection of multiple cancer types.
The company first made waves with its tests last year, when it announced it will deploy its lung cancer-detecting blood test into 50,000 people in the UK. However, it isn’t alone in its pursuit of developing new cancer diagnostics.
Roche subsidiary Foundation Medicine launched its liquid biopsy FoundationOne liquid back in September, although this test is marketed as lab-developed, the company has confirmed that it aims to seek FDA approval in the near future.
Guardant Health is another company that has developed a cancer-detecting blood test, Guardant360, and says it intends to submit a premarket approval application to the FDA.
That company’s prospects look good, and it has raised plenty of capital. Its IPO generated $238m, making it the third largest in medtech history.