Guardant Health’s New Colorectal Cancer Blood Test Results: Disappointing

• Guardant Health claimed that 83% of colorectal carcinoma cases were caught by its blood test.
• Guardant believes this could create a $20 billion market in colorectal cancer screenings.
• Investors were disappointed that the test was not able to detect precancerous tumours. 

The new era of cancer screening could be here soon. 

It may be possible to have uncomfortable procedures, such as colonoscopies. detect cancer from a simple blood draw — also known as a liquid biopsy. Guardant Health, a Silicon Valley-based biotech, announced on Thursday that its blood-based screening test for colorectal cancer detected 83% of those who had the disease. It correctly predicted that 95% of people would not develop colorectal cancer. 

In a press releaseThe company stated that it would use the study results to submit the FDA approval test in the first quarter 2023.

Guardant Health coCEO AmirAli Talasaz stated that they have been working hard for many years to reach this milestone in an investor call Thursday evening. “As of today blood-based CRC screening has become a reality.” 

After the announcement of the results, Guardant’s stock plummeted 

Some people were not thrilled by the trial’s findings. Guardant’s stock tumbled 27%Friday morning. Puneet Souda, analyst at SVB Securities, stated that although the test is likely to gain approval for its use, it won’t be the first choice for screening for colorectal carcinoma.

This is partly because the test could only detect advanced adenomas (or noncancerous tumors that may indicate a higher risk of colorectal cancer) 13% of the times. Cologuard, a competing product, is more effective at detecting precancerous types of lesions. It uses stool samples. The stock of Exact SciencesCologuard’s metric,, has risen 26%

Colorectal cancer is the most common form of cancer in the United States. according to the American Cancer SocietyNearly 45,000 new cases are diagnosed each year. It’s also deadly — it’s the third leading cause of cancer-related deaths in both men and women, and is expected to cause more than 52,000 deaths in 2022. It was the leading cause of death in 2020. Black Panther star Chadwick Boseman.

But colorectal cancer is also preventableFortunately, the death rate has been decreasing steadily over the past few years due to increased screenings. Currently the US Preventive Services Task Force recommendsAdults in the US are screened for colorectal carcinoma at 45. There are many screening tests that can be used, including stool tests and colonoscopies. A colonoscopy is recommended for people who aren’t at risk of colon cancer.

The study results could still unlock multi-billion-dollar markets

ECLIPSE, Guardant’s clinical trial in late-stage, is the most robust to date proving the effectiveness of a blood-based cancer screening test. The test works by detecting tiny particles known as circulating tumor DNActDNA, which is a result of cancerous tumors being introduced into the bloodstream. 

ECLIPSE was a trial that tested the Shield blood test (also known as Shield) on more than 22,000 patients.

Guardant stated that the market for colorectal cancer screening could reach $20 billion in the Thursday investor call. 

The company already offers several products on its market, including Guardant360CDxFDA-approved blood test for testing cancer genomic markers. It could show which cancer treatments are most likely. Shield is available in a limited number if doctors’ offices. 

The company expects that the test can be included in national screening guidelines for colorectal carcinoma by 2026. 

Sentieo reports that Talasaz stated at multiple conferences that the test’s cash price will be $895. 

It is still unknown who will pay for these tests. Guardant doesn’t know if the blood tests will be covered by Medicare or Medicaid. However, the test results are accurate enough to suggest that coverage is likely. according to guidelines for the Centers for Medicare and Medicaid Services.

In October 2010, Talasaz told Insider that five years from now, “We could have a colon-based screening test using blood from over 130 million Americans without any out of pocket costs.”

Are colonoscopies an outdated practice?

Unfortunately, a blood-based colonoscopy test will not replace it soon.

Despite the fact that they involve sedation, colorectal screening is still the gold standard. unpleasant physical preparation. In May, Souda explained to Insider that colonoscopies can be used as an interventional procedure and also as a diagnostic procedure. They can be used to screen for cancer, as well as to remove it. precancerous polypsIf they are found.

Liquid biopsies, however, are more comfortable. Talasaz said that in doctors offices that are already using the blood test, more than 90% of patients are willing to take the test — compared to about 70% of eligible patientsPatients who are eligible for current screenings will be screened. More patients being screened means more chance of early detection and more lives saved.

Guardant is the first of a number of companies that are working on similar tests

Guardant is the first company that has completed a late-stage clinical trial in order to validate its liquid biopsy test. Other biotech companies include Freenome, GRAIL, Exact SciencesThey are also developing liquid biopsy tests to detect early stage colorectal cancer. 

While colorectal cancer is currently being studied for a blood-based screen, it is not the last. Guardant will begin January enrolled its first patientInitiated a clinical trial in order to determine if its blood test could detect lung cancer in high risk adults. 

Some cancers cannot be detected using blood, as not all tumors have DNA in the bloodstream. Souda stated that there are certain cancers that cannot be detected by liquid biopsy. 

This article was updated December 16, 2022 with stock reactions and analyst comments for Guardant and Exact Sciences.