NCHR Letter to Senate HELP and House Energy & Commerce Committees Regarding the VALID Act

December 14, 2022

The Honorable Patty Murray                                     The Honorable Richard Burr
Chair                                                                                   Ranking Member
Senate Health, Education,                                           Senate Health, Education,
Labor & Pensions Committee                                    Labor & Pensions Committee
Washington, DC 20515                                                Washington, DC 20515

The Honorable Frank Pallone                                    The Honorable Cathy McMorris Rodgers
Chair                                                                                    Ranking Member
House Energy & Commerce Committee                House Energy & Commerce Committee
Washington, DC 20515                                                 Washington, DC 20515

Dear Chair Murray, Ranking Member Burr, Chair Pallone, and Ranking Member Rodgers:

Thank you for your continued work to strengthen the oversight of laboratory-developed diagnostic tests (LDTs). We strongly support the inclusion of the VALID Act in the year-end omnibus spending package. This important bill will provide the FDA with the authority and resources necessary to ensure that the highest-risk diagnostic tests are valid and reliable. We have seen the importance of diagnostic tests throughout the COVID-19 pandemic and the potential harm from an inaccurate result. Increasing numbers of patients make life-altering decisions based on diagnostic tests; in addition to tests to diagnose cancer, many genetic tests are being used to predict increased risk of cancer and other serious diseases or life-threatening fetal abnormalities. Physicians are often unaware of the origin of the tests, assuming proper oversight and evaluation has taken place. The provisions of the VALID Act will help give physicians the necessary assurances that the tests they are using on their patients are accurate.

While we support the urgent need to pass VALID in order to protect patients from inaccurate tests, we have significant concerns regarding an exemption for academic medical centers. This exemption would undercut the core goal of this necessary reform: creating more rigorous, standardized oversight requirements for all tests no matter where they are made. We also remain concerned about the grandfathering of all tests currently on the market, regardless of the potential risk category. This is troubling given the broad range of tests currently on the market that are known to be inaccurate or to fail to reliably capture important medical information. For example, a New York Times review found that the five most common prenatal genetic tests performed were incorrect 85% of the time, and yet they are able to be advertised as “reliable” and “highly accurate” due to a lack of FDA oversight and regulation. One test for Prader-Willi syndrome, a very serious condition that can cause seizures and makes it unlikely that an adult can live independently, was found to produce a false-positive result more than 90% of the time. Based on the current lack of FDA authority, companies can legally develop and sell these important tests without physicians or patients realizing how inaccurate they are.

All labs and tests should be held to the highest standards when it comes to providing physicians and patients with critical medical information. As currently drafted, the standards in VALID would be unacceptably low for what the FDA considers “low-risk” and “medium-risk” tests, such as genetic tests. The higher standards would focus instead on only the highest risk tests, such as those diagnosing cancer. The degree of scrutiny for genetic tests that inform patients whether they are likely to develop specific types of cancer or other serious diseases remains unclear, even though such a test result could convince the patient to undergo irreversible surgery, such as a mastectomy, hysterectomy, or stomach removal. The same is true for prenatal tests that could result in extreme parental stress or decisions to terminate a wanted pregnancy. These genetic tests should be categorized as high risk in the legislation.

We understand the competing interests from the multiple stakeholders involved and appreciate your efforts to narrow any exemption for academic medical centers. However, we continue to have concerns regarding high-risk tests currently being used and the FDA’s tendency to have low standards of evidence for moderate risk devices that patients and families would consider high risk. We strongly urge you to keep patients in mind as you finalize this important piece of legislation. The results from these tests have the potential to lead to life-changing medical decisions. Patients and physicians have the right to know they can trust the results being provided, regardless of where and when the test was developed.



Diana Zuckerman, PhD
National Center for Health Research