Grail initiates massive multicenter breast cancer study

The results of the study will serve as a baseline measure for detecting breast cancer in the blood and inform the development of Grail’s pan-cancer screening test.

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Illumina spin-out Grail announced a new multicenter clinical study on Thursday and, true to form, it’s a large-scale endeavor.

Dubbed STRIVE, the longitudinal, prospective, observational study will seek to enroll up to 120,000 women undergoing routine mammograms at Mayo Clinic and throughout the Sutter Health system in Northern California. For those who consent, a blood sample will be taken during the visit to serve as a baseline measure for detecting breast cancer in the blood.

“In order to develop and validate a blood test for the early detection of breast cancer, we need the participation of up to 120,000 women,” said Grail’s head of clinical development, Anne-Renee Hartman in a prepared statement. “GRAIL’s cutting-edge clinical technology enables us to enroll at scale and speed while collecting high-quality clinical outcomes data.”

The information will also be used to inform a pan-cancer test; part of Grail’s unprecedented mission to detect multiple early stage cancers through routine screening of a patient’s blood, the statement said.

It’s a massive undertaking, which helps explain why and how the less than 18-month-old company managed to raise the largest-ever private biotech financing round in early 2017. With backing from ARCH Venture Partners, Amazon, Bezos Expeditions, Bill Gates and more, Grail now has secured over $1 billion in funding.

Studies like STRIVE won’t be cheap or easy, but they are necessary to gain the depths of data required to understand the nuances of individual blood profiles. One of the major areas of interest is cell-free nucleic acids (cfNAs), fragments of tumor DNA and RNA that may be circulating in the blood during the very earliest stages of the disease.

At the Future of Genomic Medicine conference held in San Diego in March, Grail CEO Jeff Huber explained that the early detection it seeks will require sensitivity down to just a handful of molecules in a tube of blood. Programming such a test will require hundreds of thousands of samples from healthy participants and those that are later diagnosed with cancer.

The actual test will deploy ultra-deep, ultra-wide sequencing; a high-intensity approach that Huber described as an order of magnitude deeper than traditional sequencing.

“The net effect of that is that we’re generating on the order of a terabyte of data for every test that we do,” he told the audience.

STRIVE is the second large-scale study to be commenced by Grail, following the Circulating Cell-free Genome Atlas (CCGA) study that kicked off in December 2016. CCGA aims to analyze blood samples from 10,000 participants; 7,000 with cancer and 3,000 controls, to build a detailed reference library for what a normal blood profile looks like. Mayo Clinic is also a primary academic partner on this program.

More studies are planned in the coming years, the company states, which will cumulatively enroll hundreds of thousands of patients. Stay tuned.

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