Grail said it had begun selling its multi-cancer blood test in the U.S.
DreamstimeThe private cancer testing firm Grail said early Friday that it had begun selling its multi-cancer blood test in the U.S., making it the first company to hit what could ultimately be a vast market for simple tests that find a range of cancers early.
Grail also presented data from an ongoing trial of the test, called Galleri. The company said that Galleri had accurately detected 29 cancers across the trial population of more than 6,500 people aged 50 and older. The cancers it detected were of 13 different types, including breast, lung, and prostate. Nearly 40% of the cancers the test detected were still localized.
The company said that interim data from the trial showed that the odds that a person actually has cancer when Galleri returns a positive test result is 44.6%, which the company said was consistent with earlier trials.
The false positive rate for the test, which is calculated based on the total population screened, is less than 1%, according to an earlier trial of Galleri.
“Finding cancer early, when treatment is more likely to be successful, is one of the most significant opportunities we have to reduce the burden of cancer,” said Dr. Joshua Ofman, Grail’s chief medical officer, in a statement. “These data suggest that, if used at scale alongside existing screening tests, the Galleri test could have a profound impact on how cancer is detected and, ultimately, on public health.”
The news will add more fire to the growing controversy over the gene sequencing giant Illumina’s (ILMN) effort to buy Grail, which had been planning an initial public offering before Ilumina swept in last year. The acquisition has been held up by regulators, both in the U.S. and in Europe. Earlier this week, Illumina’s CEO, Francis deSouza, accused the Federal Trade Commission of “time-wasting maneuverings” in an interview with the Financial Times.
The FTC has held up its own court efforts to challenge the acquisition amid wranglings between Illumina and European regulators. Illumina’s CEO told the FT he wanted the FTC to move forward, and get the case done with.
Illumina shares, which fell 2% on Thursday, were down 0.1% in premarket trading. The stock is up 9.3% so far this year.
Developing a multi-cancer blood test has been something of a holy grail for the diagnostics industry, hence the firm’s name. As Barron’s reported in April, Exact Sciences (ticker: EXAS) is also working toward a multi-cancer blood test. Grail has now beat Exact Sciences to market. Shares of Exact Sciences were up 0.5% in premarket trading on Friday.
Other companies, including Roche Holding (RHHBY), Guardant Health (GH), and others, already sell so-called liquid biopsies used in cancer patients.
Grail said that Galleri will be available in the U.S. by prescription only, and is intended for people at an elevated cancer risk, to be used as a complement to existing screening tests for single cancers.
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