Liquid biopsy startup Grail Inc., of Menlo Park, Calif., has reeled in $390 million in a series D financing that included new investors Public Sector Pension Investment Board and Canada Pension Plan Investment Board. Prior investor Illumina Inc., of San Diego, also participated in the round, as well as two unidentified backers.

The late-stage venture company has earmarked the funds for continued development and commercialization of its blood-based multicancer early detection test. Since 2016, Grail has raised in excess of $1.9 billion in four equity financing rounds.

“Grail is making significant progress with our blood-based, multicancer early detection test,” said Hans Bishop, Grail’s CEO. “Nearly 80% of cancer deaths result from cancer for which there is no screening test today, and Grail’s mission is to change that through the early detection and localization of more than 50 cancers. Enabling this through a single blood draw could improve patient access and adherence to cancer screening and address disparities in cancer care by improving access for rural, vulnerable and underserved populations.”

Methylation-based technology

Liquid biopsy has long been considered a pathway to earlier cancer diagnosis, treatment and even prevention. Grail’s methylation-based technology keys in on the most informative regions of the genome and employs a proprietary database and machine-learning algorithms to detect if cancer is present and in what tissue it originated.

Results from a sub-study within Grail’s more than 15,000 patient Circulating Cell-free Genome Atlas (CCGA) clinical trial showed that the company’s test could detect 43.9% of stage I to stage III cancers across 50 cancer types. In a prespecified set of 12 of the deadliest cancers in the stage range, the detection rate reached 67.3%. The test has a very low false positive rate of less than 1%, based on specificity of 99.3%. In cases where a cancer signal was detected, the assay correctly identified the tissue of origin 93% of the time – an important factor in determining treatment.

Grail sees strong potential for its liquid biopsy test in detecting very aggressive cancers, which are known to shed large amounts of genetic material into the bloodstream.

In addition to the CCGA study, Grail is enrolling up to 6,200 participants in its PATHFINDER study, a prospective, multicenter, single-arm trial of people ages 50 and older with elevated and nonelevated risk for cancer. The trial – the company’s first interventional study – is slated to report initial results next month, though the COVID-19 outbreak could set that plan back a bit.

Grail is also conducting two studies to assess the feasibility of population screening – STRIVE, a large, prospective U.S. trial, and the U.K.-based SUMMIT trial. The company hopes to use the results from those studies to support a PMA submission for FDA approval but, again, the coronavirus could delay progress toward that goal.

“At this time, several of our study partners have paused recruitment for our SUMMIT and PATHFINDER clinical studies out of an abundance of caution for public health and safety,” a Grail spokesperson told BioWorld. “We are in close contact with our research partner sites and are continuing to monitor the situation.”

The company previously said its goal is to offer the liquid biopsy as a laboratory-developed test by the spring of 2021, assuming no disruptions from the COVID-19 pandemic.

Competitive space

The liquid biopsy market is hot. Redwood City, Calif., startup Karius Inc. recently raised $165 million in series B funds to advance its cell-free DNA liquid biopsy in the area of infectious disease detection, identification and treatment. The Karius test leverages next-generation sequencing and artificial intelligence to identify and measure the microbial cell-free DNA of more than 1,400 clinically relevant pathogens.

Other recent investments include Rarecyte Inc., which scooped up $22 million in December in a series F round aimed at expanding global sales of its instruments and consumables platform in clinical research markets. The company is especially interested in companion diagnostics and has beefed up its regulatory and clinical development capabilities to support CDx partnerships with drug companies. Hong Kong-based Lucense Diagnostics Pte. Ltd raised $20 million in series A funding, while Oncocell MDx Inc. pulled in $22.2 million in a series B round.

Meanwhile, Caris Life Sciences, of Irving, Texas, is developing a liquid biopsy to detect early-stage cancer detection, based on the next-generation sequencing-based assay it recently launched, MI Exome. That assay covers all 22,000 DNA genes in the human genome and detects DNA point mutations, insertions or deletions and number alterations, as well as identifying some 250,000 exonic, intronic and intergenic single nucleotide polymorphisms.

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