Cancer-Detecting Blood Tests Gain Ground as New Market Opens Up

Grail and rivals including

Exact Sciences Corp.

, Freenome Holdings Inc. and

Guardant Health Inc.

have started studies of similar tests that aim to enroll tens of thousands of people. The companies said they hope to generate sufficient evidence of their accuracy and utility to secure approval from the Food and Drug Administration. The FDA declined to comment on applications from Grail or other companies.

The tests are at the heart of regulatory fights in the U.S. and Europe, where regulators have raised concerns about competition in the field in their attempts to unwind Illumina’s $7.1 billion acquisition of Grail in 2021. Illumina, which makes the gene-sequencing machines that Grail and its rivals use to process blood tests, is fighting the antitrust efforts but said it is exploring options for Grail that could include a divestiture.

The tests, also known as liquid biopsies, could augment the few established screening tools, such as mammograms for breast cancer and colonoscopies for colorectal cancer. And they could become sentinels for other tumor types that lack validated screens. SVB Securities analyst

Puneet Souda

estimates that they could eventually generate $50 billion in annual sales.

Researchers have long known that DNA and other biological markers of tumors circulate in the blood, and doctors have started using blood-based tests to manage care for some patients already diagnosed with cancer. Improvements in the gene-based technology behind the tests have moved the field closer to a long-held goal: blood tests that can detect cancers at their earliest stages, when treatment might lead to better outcomes.

“When you can find cancer before it spreads, there’s an enormous difference in mortality,” said

Joshua Ofman,

Grail’s president.

The field is young and there are limits to the accuracy of the tests, cancer researchers and doctors said. The tests haven’t been proven to prolong the average survival of cancer patients. They miss cancers in some people and incorrectly flag it in others, studies have shown, though they have a lower rate of false positives than false negatives. Some doctors said the tests could lead to unnecessary follow-up or risky treatment for slow-growing tumors.

“We’re excited about the potential that these tests offer, concerned that we don’t have enough data at this time to really understand how best to use them,” said

Lori Minasian,

deputy director for the Division of Cancer Prevention at the National Cancer Institute.

The NCI said it plans to start enrolling some 24,000 people in 2024 for an initial study of the tests, before a larger trial that will include up to 225,000 people. The research aims to explore potential survival benefits, the period between a positive signal and diagnosis, and whether certain tests might be better for particular groups of people. The U.K’s. National Health Service is working with Grail and has enrolled some 140,000 people in a similar study.

Menlo Park, Calif.-based Grail in September released results of a study of its Galleri test showing that among some 6,600 patients 50 and over, a cancer signal was positive in 92 participants. Among those with a positive test, about 38%, or 35 people, were diagnosed with cancer within 12 months.

The test returned a false positive in less than 1% of people screened in the trial. About 30% of those people underwent an invasive procedure such as an endoscopy or a biopsy. No serious adverse events were reported, the company said.

An additional 85 people in the trial had their cancers caught through other screening or because they developed symptoms. Earlier data from 2021 suggest that the test is better at detecting cancers at later stages.

Point32Health Inc., a Massachusetts-based health insurer, has covered Grail tests for its employees since late 2021, said

Michael Sherman,

the insurer’s chief medical officer. The company plans to offer coverage for people enrolled in its health plans, starting with a pilot including several thousand people, he said. Dr. Sherman said it will be important to determine whether the tests are suitable for certain subgroups or the general population.

“In five years the question won’t be, ‘Is this something people should get?’ I think the issue will be who should get it and how often,” he said.

Vincere Cancer Center in Scottsdale, Ariz., is using Galleri tests to screen first responders, who are at elevated risk for some cancers from exposure to carcinogens such as diesel fumes or asbestos. The test has caught cancers that other screening missed, said

Pablo Prichard,

the center’s co-founder. It has also missed some cancers that were caught with other tools.

“It’s not a stand alone. It’s a great complementary test,” he said.

Madison, Wis.-based Exact Sciences makes a test that detected about 15 cancers in a recent study comparing blood samples from cancer patients with samples from people presumed to be healthy. Across confirmed cancer cases, the test correctly detected 61% of cancers. The test correctly came back negative 98% of the time, the company said.

Freenome of South San Francisco, Calif., is developing a blood test for colorectal cancer that Chief Executive

Mike Nolan

said could help improve screening rates. He said Freenome expects to start selling the test in about two years, pending a 42,000-person clinical study and regulatory review.

Palo Alto, Calif.-based Guardant made its blood test for colorectal cancer available via prescription in May. The test can correctly detect some 91% of colorectal cancers, the company said, and can correctly rule out the cancer 92% of the time. The company said it plans to release results of its 12,700-patient trial among people ages 45 to 84 at average risk later this year before seeking regulatory approval.

Write to Peter Loftus at [email protected] and Brianna Abbott at [email protected]

Grail and rivals including

Exact Sciences Corp.

, Freenome Holdings Inc. and

Guardant Health Inc.

have started studies of similar tests that aim to enroll tens of thousands of people. The companies said they hope to generate sufficient evidence of their accuracy and utility to secure approval from the Food and Drug Administration. The FDA declined to comment on applications from Grail or other companies.

The tests are at the heart of regulatory fights in the U.S. and Europe, where regulators have raised concerns about competition in the field in their attempts to unwind Illumina’s $7.1 billion acquisition of Grail in 2021. Illumina, which makes the gene-sequencing machines that Grail and its rivals use to process blood tests, is fighting the antitrust efforts but said it is exploring options for Grail that could include a divestiture.

The tests, also known as liquid biopsies, could augment the few established screening tools, such as mammograms for breast cancer and colonoscopies for colorectal cancer. And they could become sentinels for other tumor types that lack validated screens. SVB Securities analyst

Puneet Souda

estimates that they could eventually generate $50 billion in annual sales.

Researchers have long known that DNA and other biological markers of tumors circulate in the blood, and doctors have started using blood-based tests to manage care for some patients already diagnosed with cancer. Improvements in the gene-based technology behind the tests have moved the field closer to a long-held goal: blood tests that can detect cancers at their earliest stages, when treatment might lead to better outcomes.

“When you can find cancer before it spreads, there’s an enormous difference in mortality,” said

Joshua Ofman,

Grail’s president.

The field is young and there are limits to the accuracy of the tests, cancer researchers and doctors said. The tests haven’t been proven to prolong the average survival of cancer patients. They miss cancers in some people and incorrectly flag it in others, studies have shown, though they have a lower rate of false positives than false negatives. Some doctors said the tests could lead to unnecessary follow-up or risky treatment for slow-growing tumors.

“We’re excited about the potential that these tests offer, concerned that we don’t have enough data at this time to really understand how best to use them,” said

Lori Minasian,

deputy director for the Division of Cancer Prevention at the National Cancer Institute.

The NCI said it plans to start enrolling some 24,000 people in 2024 for an initial study of the tests, before a larger trial that will include up to 225,000 people. The research aims to explore potential survival benefits, the period between a positive signal and diagnosis, and whether certain tests might be better for particular groups of people. The U.K’s. National Health Service is working with Grail and has enrolled some 140,000 people in a similar study.

Menlo Park, Calif.-based Grail in September released results of a study of its Galleri test showing that among some 6,600 patients 50 and over, a cancer signal was positive in 92 participants. Among those with a positive test, about 38%, or 35 people, were diagnosed with cancer within 12 months.

The test returned a false positive in less than 1% of people screened in the trial. About 30% of those people underwent an invasive procedure such as an endoscopy or a biopsy. No serious adverse events were reported, the company said.

An additional 85 people in the trial had their cancers caught through other screening or because they developed symptoms. Earlier data from 2021 suggest that the test is better at detecting cancers at later stages.

Point32Health Inc., a Massachusetts-based health insurer, has covered Grail tests for its employees since late 2021, said

Michael Sherman,

the insurer’s chief medical officer. The company plans to offer coverage for people enrolled in its health plans, starting with a pilot including several thousand people, he said. Dr. Sherman said it will be important to determine whether the tests are suitable for certain subgroups or the general population.

“In five years the question won’t be, ‘Is this something people should get?’ I think the issue will be who should get it and how often,” he said.

Vincere Cancer Center in Scottsdale, Ariz., is using Galleri tests to screen first responders, who are at elevated risk for some cancers from exposure to carcinogens such as diesel fumes or asbestos. The test has caught cancers that other screening missed, said

Pablo Prichard,

the center’s co-founder. It has also missed some cancers that were caught with other tools.

“It’s not a stand alone. It’s a great complementary test,” he said.

Madison, Wis.-based Exact Sciences makes a test that detected about 15 cancers in a recent study comparing blood samples from cancer patients with samples from people presumed to be healthy. Across confirmed cancer cases, the test correctly detected 61% of cancers. The test correctly came back negative 98% of the time, the company said.

Freenome of South San Francisco, Calif., is developing a blood test for colorectal cancer that Chief Executive

Mike Nolan

said could help improve screening rates. He said Freenome expects to start selling the test in about two years, pending a 42,000-person clinical study and regulatory review.

Palo Alto, Calif.-based Guardant made its blood test for colorectal cancer available via prescription in May. The test can correctly detect some 91% of colorectal cancers, the company said, and can correctly rule out the cancer 92% of the time. The company said it plans to release results of its 12,700-patient trial among people ages 45 to 84 at average risk later this year before seeking regulatory approval.

Write to Peter Loftus at [email protected] and Brianna Abbott at [email protected]