NEW YORK (GenomeWeb) – Companies developing next-generation sequencing-based liquid biopsy assays said they are not surprised by Illumina's decision to launch Grail, a liquid biopsy company focused on early cancer detection, given the huge market opportunity.
Most company representatives who spoke with GenomeWeb during last week's JP Morgan Healthcare conference in San Francisco also said that Grail's focus on early cancer detection in healthy individuals, rather than on profiling tumors from cancer patients or monitoring their treatment response and disease recurrence, is an ambitious goal.
The launch could also signal a shift in Illumina's focus. Grail "solidifies our thesis that Illumina's future growth will be focused on the diagnostics market," Tim Evans, senior analyst at Wells Fargo Securities, wrote in a note following Illumina's announcement.
Despite the fact that the majority of NGS-based liquid biopsy developers use Illumina's technology for their tests, they said that the formation of Grail would not impact their relationship with Illumina and at least initially, would not result in Illumina competing with its customers.
In addition, Illumina CEO Jay Flatley said prior to the conference that Grail will only develop products for early cancer detection in asymptomatic individuals, and is not looking to tap into the tumor profiling, treatment monitoring, or recurrence testing markets.
Flatley also said that Grail would launch its first test in 2019, a timeline that other developers called ambitious. Illumina "will have to work very fast to be competitive," Helmy Eltoukhy, CEO of Guardant Health, which offers a clinical NGS liquid biopsy assay Guardant360 that assess 70 genes, told GenomeWeb.
It is an "ambitious endeavor" that will require a "significant amount of funding," Chad Robins, CEO of Adaptive Biotechnologies, told GenomeWeb.
Eltoukhy added that Illumina's decision to launch Grail was not surprising, given the huge market opportunity.
"It's hard to do things in the confines of a company that's built for tools," he said, so "it makes sense for them to actively seek [diagnostic] markets," particularly the cancer screening market, which has been estimated to be between $20 billion and $40 billion in size for stage II cancer and potentially as large as $200 billion for stage I cancer. Few other markets in the diagnostic space are that large, Eltoukhy said, which is why new companies in the liquid biopsy space are launched on a regular basis.
Matt Posard, chief commercial officer at Trovagene, which is developing liquid biopsy assays that analyze mutations in single genes from urine or blood samples, said that Illumina's decision to launch Grail validates liquid biopsy technology in general.
"It affirms what Trovagene founders envisioned and where investment dollars are going, that circulating tumor DNA is for real," he said. Trovagene, he added, is going after a slightly different market than either Grail or Guardant Health.
Rather than trying to replace tissue biopsies or develop assays for mutation discovery, Trovagene is "going after tests that are ordered as follow-up biopsies," Posard said. "We're not trying to displace the initial tissue biopsy but looking to measure the change in disease from the initial diagnosis."
As such, he said, Trovagene's technology could potentially be complementary to, rather than competitive with, developers looking to do mutation discovery.
Posard and Eltoukhy, both former employees of Illumina, said that Illumina's plans to look for signs of cancer in asymptomatic individuals would be a challenging task.
Simply finding ctDNA in someone asymptomatic for cancer would not necessarily mean that the person has cancer because the immune system is quite good at getting rid of potential threats, Posard said. So determining a threshold at which an intervention would be warranted "will be tricky even if a test is analytically highly accurate," he added.
Posard said Grail and Trovagene would not be competing in the near future, since Trovagene is not focused on developing pan-cancer tests.
Eltoukhy said the formation of Grail would not impact Guardant's relationship with Illumina, even if the two companies eventually do become competitors. "Three years ago, we probably didn't know how we would attack early cancer," Eltoukhy said. "But we've now sequenced around 20,000 cancer patients … and that knowledge opens up the pipeline and creates the possibility for earlier detection."
Foundation Medicine's CEO Michael Pellini said during a presentation at the JP Morgan Healthcare conference that Grail would not compete with his company for at least the next five years.
Foundation plans to launch a ctDNA profiling test, FoundationAct, by the end of the quarter that is geared toward patients from whom a tumor tissue sample cannot be obtained.
However, the firm has plans to expand the indications of its test from tumor profiling to therapy monitoring and recurrence testing to, potentially, early detection.
"Five years out it's possible that there will be a more direct connection [between] what they're doing and what we're doing," Pellini said. Nonetheless, Foundation is "not built to have to develop 100 percent of our own products," he noted, indicating the potential to cross-sell an early detection test developed by Grail. "If someone brings out an IVD that complements what we do, that's great," he said. "It can be another piece of our product portfolio."
In the meantime, Sequenom's CEO Dirk van den Boom quipped during a presentation at the JP Morgan conference that he didn't know why Illumina was searching for the "holy grail" when just across town, Sequenom had already made significant progress on the technology. Sequenom has been developing a 130-gene ctDNA test, but is now looking to partner with another firm to commercialize it.
The sentiment expressed by most developers was quite different from the one expressed three years ago by noninvasive prenatal testing firms when Illumina acquired Verinata Health. At the time, Verinata Health was not only a direct competitor to other NIPT firms, all of which had developed their assays on Illumina's sequencing platform, but the four US-based firms were also embroiled in patent lawsuits.
This time around, Illumina chose not to acquire an existing company, but to launch its own. The tactic was understandable, said Eltoukhy. It doesn't require Illumina to place a bet on any particular liquid biopsy developer and enables the company to "take things into [its] own hands," he said.