BioPharma, Diagnostics

The competition: Who is Illumina’s new $100M startup, Grail, up against in cancer liquid biopsy screening?

Who are some other players in the cancer liquid biopsy market? We've got Trovagene, Circulogene, Pathway Genomics and more... but can they compete with Illumina's new startup, Grail?

blood test

On the eve of this year’s J.P. Morgan Healthcare Conference, Illumina made a much-hyped announcement: With $100 million in Series A funding, it just launched Grail, a diagnostics startup that is developing a pan-cancer blood test. The circulating tumor DNA test is meant to screen for all cancers – with a bold mission to catch the disease in asymptomatic individuals.

“Grail will have a first-mover advantage in the cancer screening market,” CEO Jay Flatley said in a conference call on Sunday. Indeed, he said Grail’s liquid biopsy diagnostic, or “molecular stethoscope” if you’d prefer, is slated for the first wave of consumer use by 2019.

But other companies have been touting advances in liquid biopsy screening for some time now. This is hardly the first gander at a pan-cancer test, right? San Diego-based Pathway Genomics, for instance, announced this past summer that it had “the first liquid biopsy test for cancer” – meant to test asymptomatic individuals at high risk for cancer.

So the biggest difference here is scale: Grail is going straight for the mass market. With Illumina’s firepower, Grail is uniquely positioned to make a bolder initial play in the liquid biopsy space. Indeed, Flatley talked big numbers straight off the bat, depending on how sensitive its circulating tumor DNA and RNA testing turns out to be:

“If we can detect stage two across a broad range of cancers, we believe the addressable market for Grail will be approximately $20 billion to $40 billion,” Flatley said.

If the sensitivity is reliable enough to pick up cancers at Stage 1, and determine tissue of origin, the market could exceed $100 billion, he said. And with $100 million in early funding from backers like Jeff Bezos, Bill Gates, Sutter Hill Ventures and ARCH Venture Partners, the startup is well-capitalized to sidestep a safer approach to cancer screening – that is, using liquid biopsy for disease monitoring in existing cancer patients.

“This company in many ways is totally distinct from what we know of in the market today,” Flatley said. “Most of what’s being done in circulating tumor DNA has to do with molecularly profiling tumors in patients who have been diagnosed – measuring minimum residual disease, or monitoring for recurrence.”

Flatley was extremely careful to qualify his statements about liquid biopsy testing – saying that accuracy and the ability to rule out false positives was of prime importance. Grail will be conducting population-scale clinical validation trials starting next year, mainly to devise a way to whittle away as many of these false positives as possible.

After all, Pathway Genomics did launch its liquid biopsy test this past summer – but thanks to the issue of false positives, it was geared specifically for a set of individuals at high-risk for cancer, as opposed to a population-wide test. And it still faced a maelstrom of criticism for doubts on accuracy – and was even handed a warning letter from the Food and Drug Administration for its possible direct-to-consumer marketing approach.

Guardant Health just closed a $100 million round, itself, this past week for its approach to liquid biopsy. Exosome Diagnostics also last week closed out a significant round – $60 million in a Series B – both with aims for cancer management.

Freenome, a fledgling upstart based in Philadelphia, appears to have broad ambitions in the vein of Grail’s – with a tagline being the apt, “unleash the power of cell-free DNA.” It’s approach is to take the Theranos route here, using a single drop of blood to make broad cancer diagnoses. The startup’s still housed in an incubator, however, and is operating off a scant $800,000, according to a regulatory filing.

“We are currently co-developing a technology that will allow us to develop an alternative sequencing method that will enable real-time sequencing (hours) and analysis of ctDNA for less than $1000,” it says on its website.

The other contenders in the liquid biopsy space are, as Flatley pointed out, more focused on patient monitoring.

Biocept, another San Diego player in the liquid biopsy game, is focused on screening for specific cancers – lung and breast. Actually, Flatley said that the first targets that will help validate Grail’s diagnostic’s specificity are lung and breast cancers – marking these indications particularly amenable to liquid biopsy.

San Diego’s Trovagene is a “precision cancer monitoring” company as well, using the liquid biopsy approach to measure circulating tumor DNA in patients already diagnosed with cancer through other testing forms.

Circulogene, an Alabama startup, has a single-blood-drop liquid biopsy test that screens for 10 cancers – with aims, again, to be used as a monitoring tool. The company’s capital is dwarfed in comparison to Grail’s – it has raised about $1.23 million to date, according to a regulatory filing.

So, broadly, it seems as though Flatley’s contention was true: They may indeed be the first to market with a broad cancer screen.

Grail’s been in the works for 18 months, Flatley said – which is interesting when you consider Illumina’s December launch of its TruSight RNA Pan-cancer screening panel aimed at the research community. Such a test is a clear foundation for Grail’s broader pursuits.

“Clearly, over the past few years, we and many other companies in fact have been researching this area of circulating tumor DNA, and it’s become clear that these molecules are present in the blood,” Flatley said. “The challenge here is finding this with the exquisite sensitivity necessary to use it as a screen.”

[Image courtesy of Flickr user Rosemary]

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