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Cell-free DNA Cancer Screening Genetic Tests

1. What is the decision or change (e.g., clinical topic, practice guideline, system design, delivery of care) you are facing or struggling with where a summary of the evidence would be helpful?

We are interested in the effectiveness and harms, and particularly the clinical utility of cell-free DNA cancer screening genetic tests.

Population: Individuals at average or high risk for cancer.

Intervention: Circulating tumor cell-free DNA blood tests for cancer screening.

Comparator: Routine cancer screening care, laboratory tests, imaging (e.g., ultrasounds, mammogram) or procedures (e.g., colonoscopy).

Outcome: Overall mortality, cancer specific mortality, harms (e.g, false positives, additional testing, emotional distress), costs

2. Why are you struggling with this issue?

This is a rapidly changing field, with multiple tests being developed by commercial laboratories as well as hospital laboratories. Clinicians, patients, and payers do not have good ways of deciding about the use of these tests. There is concern about coverage and use of these emerging tests without evidence of clinical utility and knowledge about their potential risks.

3. What do you want to see changed? How will you know that your issue is improving or has been addressed?

Our members would have enough information to inform their coverage decisions. More generally beyond any specific tests, a decision framework that could help inform ongoing decision making about tests that are introduced after the production of this report would be welcome.

4. When do you need the evidence report?

Wednesday, January 1, 2025

5. What will you do with the evidence report?

This report will be used to inform policies and coverage of these tests across approximately half of the US states, within their Medicaid programs. This report topic was discussed by the Medicaid Evidence-based Decisions (MED) Project, which is a collaborative of 22 state Medicaid programs. The discussion document is attached for your information. The topic was not prioritized by the MED collaborative for their January through June 2024. However, this was because of competing priorities that were felt to be more urgent in nature.

The topic remains of high longer-term interest and they collaborative felt that it was a topic that was of more universal interest to other constituencies for AHRQ. We are open to any appropriate review type to address this topic, including rapid reviews, technical briefs, or full systematic reviews. We would be pleased to discuss the topic further if you have questions.

Supporting Documentation

MED Scope Statement (PDF, 437 KB)

Optional Information About You

What is your role or perspective? Professional Organization

If you are you making a suggestion on behalf of an organization, please state the name of the organization - Medicaid Evidence-based Decisions Project

May we contact you if we have questions about your nomination? Yes

Page last reviewed January 2024
Page originally created June 2023

Internet Citation: Cell-free DNA Cancer Screening Genetic Tests. Content last reviewed January 2024. Effective Health Care Program, Agency for Healthcare Research and Quality, Rockville, MD.
https://effectivehealthcare.ahrq.gov/get-involved/nominated-topics/genetic-tests

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