Illumina Taking a Stab at Early-Stage Cancer Detection Test

A new venture from the world’s largest DNA sequencing company aims to detect cancer via blood tests before symptoms arise.

Over the weekend, the San Diego-based Illumina announced that its blood tests should reach the market by 2019, and cost around $1,000 or less.

Illumina, for the venture, has created a new company called Grail. Thus far, the new company has raised over $100 million, which includes funding not only from Illumina, but from venture capital firm Arch Venture Partners, Microsoft’s co-found Bill Gates, and Amazon founder and CEO Jeffrey P. Bezos.

According to MIT Technology Review, the new testing concept is referred to as “liquid biopsy.” The technique uses “high-speed DNA sequencing machines to scour a person’s blood for fragments of DNA released by cancer cells,” MIT Technology Review reports. “If DNA with cancer-causing mutations is present, it often indicates a tumor is already forming, even if it’s too small to cause symptoms or be seen on an imaging machine.”

Liquid biopsies for cancer detection and monitoring are becoming a big area of interest. Guardant Health announced on Jan. 7 that it raised $100 million for a similar liquid biopsy test. On the same day, Exosome Diagnostics announced it raised $60 million for their liquid biopsy platform.

Currently, liquid biopsies are used on patients with confirmed cancer. Tests reveal the tumor’s mutations, allowing doctors to select the best drugs for treatment, The New York Times reports.Liquid biopsies are also used to determine whether a specific treatment is effective.

The new tests will need to differentiate between mutated cells in the bloodstream caused by cancer, and mutations caused by polyps or moles, which can resemble tumors.

Additionally, at such an early stage, it is difficult to determine whether a cancer will eventually cause enough harm to warrant treatment.

“The hardest part is not only demonstrating the ability to detect cancer early, but being able to say this knowledge is in fact meaningful in terms of patient outcomes,” American Cancer Society’s Deputy Chief Medical Officer J. Leonard Lichtenfield said to MIT Technology Review.    

Last year, Pathway Genomics started offering a liquid biopsy test for early cancer detection. The test cost $699. But the test prompted a letter from the U.S. Food and Drug Administration, which informed the company the test needed proper regulatory approval. “We…have not found any published evidence that this test or any similar test has been clinically validated as a screening tool for early detection of cancer,” the letter reads.

Grail plans on conducting intensive DNA sequencing on 30,000 to 50,000 people to figure out what mutations are indicative of cancer. 

This article originally appeared in R&D.