Health and Me

Rachel V Thomas

US FDA Approves New Blood Test To Screen For Colorectal Cancer

The <span>US Food and Drug Administration</span> (<span>FDA</span>) has approved <span>SimpleScreen CRC</span>, a new blood-based screening test for <span>colorectal cancer</span> (<span>CRC</span>), the second-leading cause of cancer-related death in America.

Developed by Freenome, the test is intended for adults aged 45 and older who are at average risk for CRC. It detects cancer-associated signals from cell-free DNA (cfDNA) in the blood. However, the company said it is not a replacement for diagnostic or surveillance colonoscopy in high-risk individuals.

"A blood-based test provides another way to reach unscreened patients, and bringing more people into the screening fold leads to earlier detection and better outcomes," said Aasma Shaukat, Professor of Medicine at NYU Grossman School of Medicine.

<h2>How Does the SimpleScreen CRC Test Work?</h2>

The test is indicated for adults aged 45 years and older who are at average risk for CRC and have been referred by a healthcare provider for screening. A positive result suggests the possible presence of colorectal cancer or advanced precancerous lesions and should be followed by a colonoscopy.

A study, which enrolled over 48,000 adults across more than 200 sites, demonstrated that the test has:

<ul><li>81.1% sensitivity for detecting colorectal cancer.</li><li>13.7% sensitivity for detecting advanced precancerous lesions (APLs), including 30.7% for APLs with high-grade dysplasia.</li><li>90.4% specificity for advanced colorectal neoplasia.</li></ul>According to the company, the test correctly detected about 8 in 10 colorectal cancers while correctly producing negative results for 9 out of 10 people without colorectal cancer or advanced precancerous lesions. Freenome said it plans to develop more blood-based cancer screening tests, including for lung ⁠cancer, using the same technology platform.

<span>Abbott</span> will exclusively commercialize SimpleScreen CRC in the US.

Also read: <a href="https://www.healthandme.com/health-news/indias-national-hepatitis-program-screens-over-210-6-million-treats-612000-patients-article-155188586" data-type="tilCustomLink">India's National Hepatitis Program Screens Over 210.6 Million, Treats 612,000 Patients</a>

<h2>Why Is Colorectal Cancer Screening Important?</h2>

Colorectal cancer is highly preventable and treatable when detected early through screening. Up to 60 million Americans remain overdue for recommended screening, highlighting the need for more convenient screening options.

Although up to 90% of colorectal cancer deaths are preventable, the disease is still expected to claim more than 55,000 lives in the US this year. Regular screening remains key to early detection and improved outcomes.

Read More: <a href="https://www.healthandme.com/health-news/europe-swelters-under-heatwave-and-wildfires-360000-evacuated-what-are-the-health-risks-article-155188340" data-type="tilCustomLink">Europe Swelters Under Heatwave And Wildfires; 360,000+ Evacuated: What Are The Health Risks?</a> 

Also called colon cancer, colorectal cancer is among the most common cancers globally, yet it often goes unnoticed because its symptoms can be subtle.

"It's a cancer that can creep in quietly, and by the time it's diagnosed, it may already be at an advanced stage," said Dr. Sajjan Rajpurohit, Medical Oncologist at BLK-Max Super Speciality Hospital. "Early detection is the most powerful tool in improving survival rates."

Colon cancer often develops with subtle symptoms that are easy to overlook.

<ul><li>Persistent changes in bowel movements, such as chronic constipation or diarrhea.</li><li>Blood in the stool, whether bright red or dark.</li><li>Unexplained weight loss.</li><li>Abdominal cramps or bloating that may be mistaken for common digestive issues.</li></ul>

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Blood Test For Colorectal Cancer

SimpleScreen CRC

Freenome Blood Test

colorectal cancer

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us food and drug administration

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The US Food and Drug Administration (FDA) has approved SimpleScreen CRC, a new blood-based screening test for colorectal cancer (CRC), the second-leading cause of cancer-related death in America.Developed by Freenome, the test is intended for adults aged 45 and older who are at average risk for CRC. It detects cancer-associated signals from cell-free DNA (cfDNA) in the blood. However, the company said it is not a replacement for diagnostic or surveillance colonoscopy in high-risk individuals."A blood-based test provides another way to reach unscreened patients, and bringing more people into the screening fold leads to earlier detection and better outcomes," said Aasma Shaukat, Professor of Medicine at NYU Grossman School of Medicine.How Does the SimpleScreen CRC Test Work?The test is indicated for adults aged 45 years and older who are at average risk for CRC and have been referred by a healthcare provider for screening. A positive result suggests the possible presence of colorectal cancer or advanced precancerous lesions and should be followed by a colonoscopy.A study, which enrolled over 48,000 adults across more than 200 sites, demonstrated that the test has:81.1% sensitivity for detecting colorectal cancer.13.7% sensitivity for detecting advanced precancerous lesions (APLs), including 30.7% for APLs with high-grade dysplasia.90.4% specificity for advanced colorectal neoplasia.According to the company, the test correctly detected about 8 in 10 colorectal cancers while correctly producing negative results for 9 out of 10 people without colorectal cancer or advanced precancerous lesions. Freenome said it plans to develop more blood-based cancer screening tests, including for lung ⁠cancer, using the same technology platform.Abbott will exclusively commercialize SimpleScreen CRC in the US.Also read: India's National Hepatitis Program Screens Over 210.6 Million, Treats 612,000 PatientsWhy Is Colorectal Cancer Screening Important?Colorectal cancer is highly preventable and treatable when detected early through screening. Up to 60 million Americans remain overdue for recommended screening, highlighting the need for more convenient screening options.Although up to 90% of colorectal cancer deaths are preventable, the disease is still expected to claim more than 55,000 lives in the US this year. Regular screening remains key to early detection and improved outcomes.What Is Colorectal Cancer?Read More: Europe Swelters Under Heatwave And Wildfires; 360,000+ Evacuated: What Are The Health Risks? Also called colon cancer, colorectal cancer is among the most common cancers globally, yet it often goes unnoticed because its symptoms can be subtle."It's a cancer that can creep in quietly, and by the time it's diagnosed, it may already be at an advanced stage," said Dr. Sajjan Rajpurohit, Medical Oncologist at BLK-Max Super Speciality Hospital. "Early detection is the most powerful tool in improving survival rates."Early Symptoms People IgnoreColon cancer often develops with subtle symptoms that are easy to overlook.Common early signs include:Persistent changes in bowel movements, such as chronic constipation or diarrhea.Blood in the stool, whether bright red or dark.Unexplained weight loss.Abdominal cramps or bloating that may be mistaken for common digestive issues.

us fda approves new blood test to screen for colorectal cancer

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US FDA Approves New Blood Test To Screen For Colorectal Cancer

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US FDA Approves New Blood Test To Screen For Colorectal Cancer

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