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The VALID Act can improve lab test standards



Cancer is becoming less deadly in America.

According to the recently released Annual Report to the Nation on the Status of Cancer, overall cancer death rates have continued to decline by about 2% per year over the last several years for Americans of all ages, races, and genders. The decline in cancer death rates is clearly welcome news and coincides with a significant shift in cancer treatment through the development of new targeted therapies and accompanying diagnostic tests that guide their use.

For decades, most cancers have been treated with toxic, cell-killing treatments that had limited ability to distinguish between cancerous and normal cells. While this approach often worked, it came with significant side effects and made treatment difficult to tolerate.

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A growing number of new cancer therapies, however, use precision medicine to tailor treatment to the patient and target only cancer cells. But these targeted treatments must be matched to specific genetic markers, which can be detected only with lab tests known as biomarker tests.

Biomarker tests can help determine what an individual’s prognosis might be and which drugs would work best to treat their disease. For example, tests that detect certain genetic characteristics in breast, lung, and skin cancer can indicate who should — or should not — be treated with specialized classes of targeted drugs.

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With the advent of targeted therapies, the accuracy of a diagnostic test is critical. Yet oversight of such tests has not kept pace with innovation.

The Food and Drug Administration currently regulates and ensures only the accuracy of tests used in multiple laboratories or health care facilities. Those designed for only a single laboratory, known as laboratory-developed tests (LDTs), are left to meet less-stringent standards. That means a growing number of lab tests, including those used to determine cancer treatment for a specific patient, are offered without assurances that they work.

An example of the potential damage of faulty and poorly regulated LDTs is the stunning case of Theranos, a consumer health care startup that claimed to be able to diagnose countless ailments with a single drop of blood. The company’s touted technology never worked, thousands of people received faulty test results for a number of serious conditions. The company’s founder, Elizabeth Holmes, was recently sentenced to more than 11 years in prison for fraud.

In an earlier example, from 2008, a company claimed a lab test could detect 99% of early-stage ovarian cancers but could, in fact, detect only 1 in 15 (7%) of cases. The remaining 14 women received false positive results and may have pursued unnecessary, invasive, and even dangerous surgeries to remove healthy uteruses, fallopian tubes, and ovaries, which could affect their ability to have children and send them into early menopause.

A recent study published in the American Journal of Clinical Pathology reported that LDTs offered for the same intended use as an FDA-approved test had significant variability in their results. Errors in tests, including false negatives (when the test inaccurately states the genetic marker is not present) may impede patients’ access to safe and effective treatments for their cancers.

The VALID Act (S. 2209 and H.R. 4128), currently before Congress, provides an opportunity to set a clear, modernized regulatory framework to ensure that any test, no matter where it is developed, meets the same quality and performance standards. It also allows for continued innovation by providing detailed flexibilities that will ensure labs can still meet individual patient needs without delaying patient care.

VALID is a flexible, bipartisan bill that is the result of years of collaborative work between various stakeholders. The bill is good for industry, laboratories, providers and, most importantly, patients. An individual’s best chance to fight cancer should never be affected by something as easily preventable as a faulty diagnostic test. Congress has the opportunity today to do what is right for patients.

Jeff Allen is the president & CEO of Friends of Cancer Research. Lisa Lacasse is the president of the American Cancer Society Cancer Action Network.


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