Illumina’s (NASDAQ:ILMN) $8B takeout of liquid biopsy developer GRAIL, which it formed in 2016 with funding assistance from the likes of Bill Gates and Jeff Bezos, may be a watershed event for its use in cancer detection and management.

It is developing a multi-cancer early detection test called Galleri that detects very small amounts of tumor-associated molecular material in the bloodstream called cell-free DNA (cfDNA), also referred to as circulating tumor DNA (ctDNA), a method called liquid biopsy.

Historically, the presence of cancer has been confirmed via tissue biopsy, removing a small amount of tissue, usually via needle aspiration, for examination under a microscope by a pathologist. The invasive procedure can be painful (liver, pancreas, lung biopsy, for example) and must frequently be repeated since about one in five fails to obtain sufficient material for analysis.

Liquid biopsy overcomes these drawbacks by virtue of using a peripheral blood sample (common blood draw). It is virtually painless, can be quickly obtained by a phlebotomist using standard materials and is much less expensive.

The approach has been touted for some years but is only now starting to gain significant traction due, in large part, to advances in detection technology. Proponents tout its use in screening for cancer, therapy selection (companion diagnostics), monitoring treatment response and drug resistance and detection of minimal residual disease after surgery or recurrence. Despite the advantages, though, tissue biopsy will likely remain the gold standard for the foreseeable future (liquid biopsies should reduce the demand for tissue biopsies if clinicians have confidence in negative results).

Yesterday’s 27% spike in Exact Sciences (NASDAQ:EXAS) is another indicator of investors’ enthusiasm. Shares jumped in reaction to comments from the CEO about its plans to develop a liquid biopsy screening test for colorectal cancer.

Other noteworthy events:

FDA approval of Roche’s (OTCQX:RHHBY) pan-tumor FoundationOne Liquid CDx test.

FDA approval of Guardant Health’s (NASDAQ:GH) Guardant360 Dx for tumor mutation profiling [approved previously as a companion diagnostic for AstraZeneca’s Tagrisso (osimertinib)].

NeoGenomics (NASDAQ:NEO) to collaborate with Inivata on commercialization of the InVisionFirst-Lung liquid biopsy test in the U.S.

Medicare to cover GH’s Guardant360 for most solid tumors.

Biocept (NASDAQ:BIOC) launches Target Selector pan-TRK test for the detection of TRK proteins (aid in therapy selection). It offers 20 liquid biopsy tests.

QIAGEN (NYSE:QGEN) to collaborate with Inovio Pharmaceuticals (NASDAQ:INO) on a liquid biopsy companion diagnostic for DNA-based immunotherapy VGX-3100.

Despite the optimism, risks remain. OncoCyte (NYSEMKT:OCX) jumped 225% on January 29, 2019, closing at $5.91 after it announced positive data from a validation study of DetermaVu, its liquid biopsy test for lung cancer. Three months ago, it announced that the validation study failed to achieve the primary endpoint and development would cease. Shares closed yesterday at $1.34, down 77% since the first announcement.


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