Diagnostic Tests

Health care products


Health care providers often base diagnosis and treatment decisions on information from in vitro diagnostics (IVDs), which analyze blood, tissue, and other human samples. These tests must produce accurate and meaningful results; otherwise, patients may receive delayed, inferior, or even unnecessary medical care.

The Food and Drug Administration (FDA) reviews many IVDs to verify their accuracy and ensure that a test’s benefits outweigh its risks. However, the agency has historically exempted diagnostics developed and used within the same laboratory from this oversight process. These lab-developed tests have become widespread and increasingly complex, exposing more people to potential harm from unreliable or misleading results.

Pew conducted research on the market for diagnostic tests and advocated for legislation that would subject these products to FDA review based on their risks to patients, not where they were made.

lab technician
lab technician

Congress Must Close the Theranos Lab Test Loophole

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Theranos founder Elizabeth Holmes and chief operating officer Sunny Balwani were recently convicted of fraud for lying to investors about the company’s blood tests.

In Vitro
In Vitro
Issue Brief

What Are In Vitro Diagnostic Tests, and How Are They Regulated?

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Issue Brief

What Are In Vitro Diagnostic Tests, and How Are They Regulated?

Health care providers rely on a variety of tools to diagnose conditions and guide treatment decisions. Among the most common and widely used are <i>in vitro</i> diagnostics (IVDs), which are clinical tests that analyze samples taken from the human body. Patients may receive—or forgo—medical care based on diagnostic test results, making it critically important that tests are reliable.


Spotlight on Mental Health

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Learn the Basics of Broadband from Our Limited Series

Sign up for our four-week email course on Broadband Basics

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How does broadband internet reach our homes, phones, and tablets? What kind of infrastructure connects us all together? What are the major barriers to broadband access for American communities?

What Is Antibiotic Resistance—and How Can We Fight It?

Sign up for our four-week email series The Race Against Resistance.

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Antibiotic-resistant bacteria, also known as “superbugs,” are a major threat to modern medicine. But how does resistance work, and what can we do to slow the spread? Read personal stories, expert accounts, and more for the answers to those questions in our four-week email series: Slowing Superbugs.

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