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FDA approval · Freenome · Gastroenterology

SimpleScreen CRC

FDA approves a blood test for colorectal cancer screening in average-risk adults 45 and older.

CompareFreenome press release
Approved · PMA

SimpleScreen CRC

Freenome · Gastroenterology

Type
Diagnostic test
FDA route
Premarket approval (PMA)
Bottom line for your practice
55s read

The FDA has approved another colorectal cancer screening option for average-risk adults 45 and older that needs only a blood draw, with a US launch by Abbott planned for this fall. A positive result should be followed by colonoscopy, and the test detected few advanced precancerous lesions (13.7% sensitivity) in its validation study.

What it is
A blood test for colorectal cancer screening. It uses a blood draw and detects signals associated with colorectal cancer from cell-free DNA (cfDNA) in the blood.
Indicated for
Adults aged 45 years and older who are at average risk for colorectal cancer and are referred by a healthcare provider for screening.
What changes
The release does not compare the test's accuracy with other screening tests. The study enrolled adults who were scheduled for a screening colonoscopy, and the release describes the test as an added option alongside Cologuard that requires only a blood draw.
Evidence
Performance testingPREEMPT CRCIn a prespecified analysis adjusted to match the U.S. Census, the test detected colorectal cancer with 81.1% sensitivity and advanced precancerous lesions with 13.7% sensitivity (30.7% for those with high-grade dysplasia). Specificity for advanced colorectal neoplasia was 90.4%.Accuracy, bench or analytical testing. The source reports no clinical outcome trial, which is common for cleared devices.
Watch for
Sensitivity for advanced precancerous lesions was 13.7%. A positive result should be followed by colonoscopy, and the test is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals.
FDA decision
  1. 510(k)Cleared
  2. De NovoGranted
  3. PMAApproved
Premarket approval (PMA). The FDA's most demanding device review, for Class III devices that sustain life or carry the highest risk. It requires valid scientific evidence of safety and effectiveness, usually clinical studies, which are not always randomized.

Clinical summary

A cell-free DNA blood test approved for colorectal cancer screening in average-risk adults aged 45 and older; Abbott plans to commercialize it in the US this fall. In PREEMPT CRC (more than 48,000 participants), sensitivity for colorectal cancer was 81.1% and specificity for advanced colorectal neoplasia was 90.4%, but sensitivity for advanced precancerous lesions was 13.7%. A positive result should be followed by colonoscopy, and the test is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals.

From the source 8

Freenome press release

The Freenome press release's own words, quoted exactly. Each line is what a claim on this page was checked against.

  1. today announced that the U.S. Food and Drug Administration (FDA) has approved SimpleScreen™ CRC, a new blood-based screening option for colorectal cancer (CRC) in adults 45 and older who are at average risk for the disease.

    Backs · Pathway PMA (FDA approval of the test)

  2. The test is indicated for adults aged 45 years and older who are at average risk for CRC and referred by a healthcare provider for CRC screening.

    Backs · Indicated for adults aged 45 and older at average risk, referred by a healthcare provider

  3. In a prespecified analysis adjusted to match the U.S. Census, SimpleScreen CRC detected colorectal cancer with 81.1% sensitivity and advanced precancerous lesions (APLs) with 13.7% sensitivity, including 30.7% for APLs with high-grade dysplasia.

    Backs · 81.1% CRC sensitivity; 13.7% APL sensitivity; 30.7% for APLs with high-grade dysplasia

View all 8 lines

  1. The test showed 90.4% specificity for advanced colorectal neoplasia.

    Backs · 90.4% specificity

  2. Conducted at over 200 sites, PREEMPT CRC enrolled more than 48,000 asymptomatic, average-risk adults between the ages of 45 and 85 who were scheduled for a screening colonoscopy.

    Backs · Study enrolled adults scheduled for screening colonoscopy (no exact n: 'more than 48,000')

  3. A positive result indicates a signal was detected that may suggest the presence of colorectal cancer or advanced precancerous lesions and should be followed by colonoscopy.

    Backs · Positive result should be followed by colonoscopy

  4. SimpleScreen CRC is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals.

    Backs · Not a replacement for diagnostic or surveillance colonoscopy

  5. By adding SimpleScreen CRC alongside Cologuard, we are expanding the choices available to healthcare providers and helping remove barriers that keep too many people from getting screened.

    Backs · Added option alongside Cologuard

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