Grail, a company that spun out of Illumina back in 2016 is launching its first product, a multi-cancer blood test, in 2021 which it claims could avoid up to 39% of cancer deaths by detecting them earlier. It recently filed its S1 to go public. 

Why is this disruptive? Well, traditionally we don’t go looking for cancer until we become symptomatic. Now there are some screening tests in place to try and detect cancer early such as the PSA test for prostate cancer, a colonoscopy for colon cancer, among others. However, a multi-cancer blood test could be cost-effective enough and convenient enough that millions could be screened during their regular primary care visit. The company already raised $1.9 billion and is backed by Billionaire Jeff Bezos and they DON’T have a commercial product yet. This gives you an idea of the excitement around this future product.

Their multi-cancer detection, called Galleri, will screen individuals over 50 years old--a target population of about 107 million. The test will be a laboratory developed test (LDT) which like Theranos before it, will not require FDA approval.

How does it work? The latest study of the Galleri test could detect 50 cancer types with a false positive rate of 0.7%. The test uses Next Generation Sequencing (NGS) of nucleic acids (cfNA) circulating in the blood. Cancers or Tumors shed DNA, mRNA and microRNA into the circulating blood. If you have these in your blood, you have cancer. In the past, tests looked at the amount of cfNA to tell what the tumor burden was, but the same thing can be done using imaging or other tests that are a proxy for the tumor burden. The question scientists posed was whether we could tell what type of cancer was present and where it came from? Sometimes cancers of different organs can have the same morphology making it unclear whether the cancer in question even if identified is metastatic from the same cancer somewhere else in the body. What Grail did was sequence methylation targets of the cfNA instead of the whole genome and using a proprietary database and machine learning algorithms, it was able to localize the origin of the cancer with an accuracy of 93%. 

Will they disrupt cancer detection? Hard to say without a commercial product. As they state in their S1 “The testing and diagnostic products industry is intensely competitive. We have competitors both in the United States and abroad, including AnchorDx, ArcherDx, Inc., Burning Rock Biotech Limited, Exact Sciences Corporation, Freenome, Inc., Guardant Health, Inc., Laboratory for Advanced Medicine, PapGene, Inc., Singlera Genomics, Inc. and Thrive Earlier Detection Corp”. In fact, Thrive Earlier Detection Corp is a Johns Hopkins spinoff that got investors so excited it was able to raise $110 million after just launching in May 2019 which was soon followed by a Series B of $257 million! What’s interesting is that Thrive also doesn’t have a commercial product yet, and it's still very much looking to prove its product will work with a high enough accuracy.

Why do they need so much money? With these mega rounds, what investors are hoping for is getting to market first. Even if there is no product currently, $1.9 billion raised by Grail and $360 million raised by Thrive should be enough theoretically to get closer. Part of the cash burn is coming from launching these mega patient trials (15,000 for Grail and 10,000 for Thrive most recently) to test their product, but what they’re really doing is buying a cfNA database to improve their algorithms for the next trial and the next funding round. Grail is currently burning through $250 million a year! In comparison, Theranos only raised $700 million and we all know what happened.

Still, research in the cfNA space is potentially revolutionary and something will come out of all that hard work.