Guardant Health said its cancer screening blood test detected 83% of colorectal cancer cases.
Guardant says this could unlock a $20 billion market for colorectal cancer screening.
But some investors have been disappointed by the test’s poor ability to detect precancerous tumors.
A new era in cancer screening may soon begin.
Instead of having to undergo uncomfortable procedures like colonoscopies, it might be possible to detect cancer from a simple blood test – also known as a liquid biopsy. On Thursday, Silicon Valley-based biotech Guardant Health announced that its blood-based cancer screening test correctly detected cases of colorectal cancer in 83% of people with the disease. He also correctly predicted that people didn’t get colorectal cancer 90% of the time.
In a press release, the company said it would use these study results to submit the test for FDA approval in the first quarter of 2023.
“We have been working tirelessly for many years to reach this milestone,” Guardant Health co-CEO AmirAli Talasaz said during an investor call Thursday evening. “To date, blood screening for CRC is a reality.”
Not everyone was thrilled with the results of the trial. On the investor call, SVB Securities analyst Puneet Souda pointed out that the sensitivity figure of 83% was significantly lower than that reported by the company last May.
And while the test appears to work well for detecting colorectal cancer that is already present, the test was only able to correctly detect advanced adenomas, or non-cancerous growths that indicate colorectal cancer risk, only 13% of the time.
Guardant’s stock fell after the earnings announcement
The results sent shares of Guardant down 40% in after-hours trading. Shares of Exact Sciences, which makes a competing product called Cologuard that is more effective at detecting similar types of precancerous lesions, rose more than 25% on Thursday night.
Colorectal cancer is one of the most common cancers in the United States, according to the American Cancer Society, with nearly 45,000 new cases diagnosed each year. It’s deadly, too – it’s the third leading cause of cancer-related death in both men and women, and is expected to cause more than 52,000 deaths in 2022. In 2020, it was the Black star’s cause of death Panther Chadwick Boseman.
But colorectal cancer is also preventable, and the death rate has been steadily falling thanks to increased screenings over the past few decades. Currently, the U.S. Task Force on Preventive Services recommends that adults in the United States begin getting screened for colorectal cancer at age 45 using a variety of screening tests, such as stool tests. , sigmoidoscopies and colonoscopies. People who are not at high risk for colon cancer should have a colonoscopy every 10 years.
Study results could yet unlock a multi-billion dollar market
The late-stage clinical trial, called the ECLIPSE trial, is the most robust study to date showing the effectiveness of a blood cancer screening test. The test works by detecting tiny particles called circulating tumor DNA, or cDNA, that are released by cancerous tumors into the bloodstream.
The ECLIPSE trial tested the company’s blood test, called Shield, on more than 20,000 patients.
During Thursday’s investor call, Guardant estimated that the total market for colorectal cancer screening alone could be as high as $20 billion.
The company already has several products on the market, including Guardant360CDx, an FDA-approved blood test to test genomic cancer markers that could help show which treatments cancers are susceptible to. Additionally, Shield is already available in a limited number of medical practices.
In a Nov. 4 analyst note, Souda wrote that Guardant expects $5 billion in revenue from the Shield test once it receives FDA approval, which Guardant says will happen next year. The company also expects the test to be included in national colorectal cancer screening guidelines by 2026.
According to research firm Sentieo, Talasaz has told several conferences that the spot price for the test will be $895.
It remains to be seen who will be responsible for paying for these tests. Guardant doesn’t yet know whether the blood test will be covered by Medicare, Medicaid or private insurance companies, though the test is accurate enough that coverage seems likely according to guidelines from the Centers for Medicare and Medicaid Services.
Five years from today, Talasaz told Insider in October, “We could have a colon cancer blood test using blood for over 130 million people in the United States at no cost. .”
Are colonoscopies a thing of the past?
Unfortunately, a blood test won’t completely replace colonoscopies anytime soon.
Colonoscopies are still the gold standard for colorectal cancer screening, despite sedation and hours of unpleasant physical preparation. That’s because, Souda told Insider in a May interview, colonoscopies are an interventional procedure as well as a diagnostic procedure. In other words, not only are they a screening tool, but they can also be used to cut out precancerous polyps if found.
But liquid biopsies are a more comfortable test. Talasaz said that in doctors’ offices that already use the blood test, more than 90% of patients are willing to take the test – compared to around 70% of eligible patients who benefit from current forms of screening. And more patients screened means more chance of early cancer being detected and lives saved.
Guardant is the first in a series of companies working on similar tests
Guardant is the first company to cross the finish line with a late-stage clinical trial to validate its liquid biopsy test. Other biotech companies, including Freenome, GRAIL and Exact Sciences, are also developing their own liquid biopsy tests to detect colorectal cancer at an early stage.
And while colorectal cancer is the first cancer investigated for blood screening, it certainly won’t be the last. In January, Guardant enrolled his first patient in a clinical trial to see if he could use his blood test to detect lung cancer in high-risk adults.
However, not all cancers will be able to be detected by blood because not all tumors release DNA into the bloodstream. “There are some cancers that just won’t lend themselves to liquid biopsy,” Souda said.
Read the original article on Business Insider