- Many new blood tests to detect cancer are in the clinical trial stages.
- Experts say these tests have the potential to detect an array of cancers earlier and easier than current tests can.
- They said the earlier detection can save lives as well as help people avoid more expensive and more intrusive tests.
The buzz in the cancer research sector over the emergence of blood tests that detect cancer has reached a crescendo.
Historically, blood tests, which are often now called liquid biopsies, have not been a useful way to detect cancer.
But thanks to years of research, multiple blood tests that can potentially detect cancer are moving swiftly toward widespread consumer use.
While scientists agree that more human clinical trials are needed to push this technology forward, the science so far has proven to be sound.
And the potential for these tests are vast and could save countless lives due to early detection.
Here are some of the companies and the statuses of their blood tests.
James Howard-Tripp, chairman and CEO of StageZero Life Sciences, has been investigating the potential for blood samples to detect cancer for more than a decade.
He said his company, which utilizes advanced mRNA gene expression technology, developed the first clinically tried blood test for colorectal cancer.
Howard-Tripp told Healthline that the test was initially given to nearly 10,000 people in a North American study. It then received approval from state officials in New York. It has now been used on more than 100,000 people nationwide.
This work led to Aristotle, a test designed to detect multiple cancers from a single sample of blood.
Howard-Tripp said the liquid biopsy sector has progressed to the point where mRNA gene expression profiles, taken from a sample of whole blood, can indicate the presence of specific cancers and be used before tissue biopsies.
“A significant advantage of this mRNA approach is that it can detect cancer early in the development stages and potentially stage the cancer,” he said.
Dr. Eric Klein, chairman of the Glickman Urological and Kidney Institute at Cleveland Clinic, has been at the forefront of liquid biopsy.
He also works in cancer biomarker research, which is the study of certain abnormalities in the DNA of tumors and levels of specific proteins present in tumors.
Klein is principal investigator of a multicenter study called
“We could see these blood tests as adjuncts to current cancer screening methods, and there is the potential that these tests will replace standard screening tests,” Klein told Healthline.
Arnon Chait, PhD, the CEO of Cleveland Diagnostics, said the IsoPSA test had a sensitivity of 90 percent of high-grade prostate cancer and a specificity of 47 percent, as compared to 21 percent for the standard of care PSA and 14 percent for percent-free PSA.
The clinical data showed that IsoPSA led to a 56 percent reduction in cancer biopsy recommendations and an 18 percent reduction in MRI recommendations.
“This increased accuracy not only promotes cost savings but can also prevent unnecessary, painful procedures for patients while detecting more high-grade cancers,” Chait told Healthline.
Last year, an international team of researchers announced the development of a test that detected five different types of cancer up to 4 years earlier than current cancer tests.
The test, which is called PanSeer, detected cancer in 91 percent of samples from people who had no symptoms when the samples were collected.
They were diagnosed with cancer 1 to 4 years later.
The cancers detected in the test were stomach, esophageal, colorectal, lung, and liver cancer.
“The ultimate goal would be performing blood tests like this routinely during annual health checkups,” Kun Zhang, PhD, one of the paper’s authors, and professor and chair of the department of bioengineering at the University of California at San Diego, said last year in a statement.
“But the immediate focus is to test people at higher risk, based on family history, age or other known risk factors,” he added.
The journal Science reported last year on a study of a liquid biopsy for DNA and proteins from multiple types of cancers that was conducted in 10,000 healthy older women.
The test, called CancerSEEK, was developed at Johns Hopkins University in Maryland and licensed by startup company Thrive.
It found 26 cancers that had not been discovered with conventional screenings.
Rosemary Jemo had stage 1 ovarian cancer detected by CancerSEEK. She chose to have surgery.
“I never thought I would be the one,” Jemo told Healthline. “I have had no side effects from the surgery and am back to doing everything I did before.”
Kevin T. Conroy, chairman and CEO of Exact Sciences, which acquired Thrive and merged with it, said the potential for liquid biopsies to detect many more cancers at earlier stages has the potential to “turn the tide on what a cancer diagnosis means.”
But, he said, “we must continue our work to ensure future clinical trials and focus on making this the standard of care.”
The one concern of the CancerSEEK test is that there were more than 100 false positives.
“Multi-cancer earlier detection tests must have a very high specificity of 99 percent or better, meaning a much lower false-positive rate than standard of care single-organ tests like mammograms,” Conroy said.
Given that the likelihood of cancer is low in an asymptomatic population, he said, “the false alarms need to be minimized.”
Conroy explained that a positive CancerSEEK test is followed up with a diagnostic PET-CT scan to confirm and localize the presence of cancer and minimize anxiety for participants.
Meanwhile, GRAIL, which is among the industry’s leaders, continues to expand its reach.
Last week, Britain’s National Health Service (NHS) began the world’s largest trial of GRAIL’s Galleri, a blood test that can detect more than 50 types of cancer before symptoms appear.
The NHS hopes to recruit 140,000 volunteers in England to see how well the test works.
“It is exciting that other companies recognize the potential of multi-cancer early detection, as changing the paradigm will require great science and great companies,” Dr. Joshua J. Ofman, GRAIL’s chief medical officer and head of external affairs, told Healthline.
“The progress in the sector is encouraging, but there is urgency because most cancers are still detected too late, and more than 600,000 Americans will die from cancer this year alone,” he said.