NOV 24, 2015 1:11 PM PST

High Financial and Health Costs of Inaccurate Lab Tests, FDA Reports

WRITTEN BY: Xuan Pham
In a time when precision medicine and genetic testing are booming, the Federal Drug Administration (FDA) is taking a step back and stringently re-examining the accuracy of laboratory-developed tests.
 
More Stringent Regulations May Be on the Horizon for Laboratory Developed Tests

A recent FDA report to Congress examined 20 case studies of laboratory-developed tests (LDTs) that did not meet FDA requirements. The report concluded that these tests “may have caused or have caused actual harm to patients.” Of the 20 case studies, 10 involved tests used to diagnose and treat cancer, while the remaining 10 involved heart disease, Lyme disease, and autism. In all 20, the FDA outlined many serious diagnostic problems of the LDTs and the clinical implications of such inaccurate test results.

Several ovarian cancer screening and detection tests (OvaCheck, OvaSure Screening Test) claim to use biomarkers in blood samples to detect presence of cancer cells. The FDA found that for both tests, there were no validations that the tests actually predict or detect ovarian cancer. In addition, the tests had inflated positive predictive values, meaning that their accuracy claims are unsubstantiated and the tests result in a high number of false positives. Since the screens target women at risk for ovarian cancer, false-positive results may lead women to undergo unnecessary surgery to remove their healthy ovaries, while false-negative results may lead to inappropriate treatments.

Another test that has the potential to yield too many false-negatives and false-positive results is non-invasive prenatal testing, also known as cell-free DNA testing. While these tests have been lauded for being non-invasive and safer than traditional amniocentesis and chorionic villi sampling, the FDA found a “lack of clinical validation that tests detect and predict fetal abnormalities at an appropriate rate.” Further, the report cited “many false-positive results when used in the general population.” The consequences of these inaccurate results could lead women to unnecessarily abort a normal pregnancy or “deliver a child with an unanticipated genetic syndrome.”

The report also included LDTs that claim to identify causes and treatments for a disease based on “disproven scientific concepts.” Case in point, an LTD (CARE Clinics BioMarkers) that claims to determine cause for autism spectrum disorder reportedly shows “no evidence that [causes] identified by the test correlate with autism. Even worse, the LTD recommends treatments that include chelation, hyperbaric oxygen, and intravenous vitamin therapy. These interventions have shown no evidence to be effective and have all been discredited by the medical community.  
 
In addition to direct patient harm, the FDA cited the high financial costs of these inaccurate and unreliable LDTs. For autism, the FDA estimates the cost impact of the inaccuracy to be $66.1 million for the 2,027 children tested and treated by the CARE Clinics. And for each ovary removal due to a false-positive ovarian cancer result, the cost of the inaccuracy is over $12,000. On the other hand, for each false-negative breast cancer result, the cost of inaccuracy is near $800,000.

Results of this report will likely promote more rigorous standards for LDT validation and regulation by the FDA. Some argue that the new standards will be the most significant change in the regulation of laboratories since 1988.
 

Additional Source: NY Times
About the Author
  • I am a human geneticist, passionate about telling stories to make science more engaging and approachable. Find more of my writing at the Hopkins BioMedical Odyssey blog and at TheGeneTwist.com.
You May Also Like
APR 13, 2021
Cardiology
Can a Ketosis Metabolite Act as a Biomarker for Cardiovascular Diseases?
APR 13, 2021
Can a Ketosis Metabolite Act as a Biomarker for Cardiovascular Diseases?
Quick and reliable diagnostics are the key to controlling many diseases, including cardiovascular disease. Biomarkers ar ...
APR 22, 2021
Clinical & Molecular DX
Gum Disease Makes COVID Patients More Likely to Die
APR 22, 2021
Gum Disease Makes COVID Patients More Likely to Die
Gum disease is associated with an increased risk of COVID-related ICU admission and death, says a study by McGill Univer ...
APR 19, 2021
Genetics & Genomics
Better Disease Risk Predictions May Come From Ancestry Data, Not Race
APR 19, 2021
Better Disease Risk Predictions May Come From Ancestry Data, Not Race
Researchers have suggested that it's time for medicine to move away from demographic labels that are too narrow to captu ...
APR 27, 2021
Clinical & Molecular DX
No Batteries: Health Sensor Harvests Biomechanical Energy
APR 27, 2021
No Batteries: Health Sensor Harvests Biomechanical Energy
An international team of researchers has developed a wearable health monitor that works without the need for batteries. ...
JUN 08, 2021
Neuroscience
Simple Blood Test Can Detect Depression and Underlying Neurodegeneration
JUN 08, 2021
Simple Blood Test Can Detect Depression and Underlying Neurodegeneration
Researchers led by King’s College London have found that levels of a protein known as neurofilament light chain (N ...
SEP 20, 2021
Cancer
An Established Ovarian Cancer Antigen Presents a Promising Therapeutic Target
SEP 20, 2021
An Established Ovarian Cancer Antigen Presents a Promising Therapeutic Target
For the past several decades, cancer antigen 125 (CA 125), a protein located on the surface of ovarian cancer cells, has ...
Loading Comments...