There is a new call to closely police a type of medical testing, based on evidence the testing can lead to serious medical errors.
What is a Laboratory Developed Test?
In November 2015, the Food and Drug Administration, which regulates this country’s medical devices, released a report on laboratory developed tests. A laboratory developed test is medical testing using specialized medical devices made in one laboratory and used in doctors’ offices, hospitals, and other laboratories.
This medical testing is called “in vitro diagnostic” because it uses samples drawn from patients, such as blood or DNA.
The report highlighted 20 case studies that showed actual or potentially great patient harm involving LDTs and concluded more scrutiny is needed on the medical devices used.
LDTs were originally limited to simple testing. In issuing its new report, the FDA said that LDTs now are playing a larger role and used for more complex procedures in healthcare today, which drew the agency’s attention.
It found numerous medical errors based on wrong laboratory developed tests, specifically citing the 20 instances. Some were false positives. Those patients were told they had some condition when they did not. They were needlessly subjected to great emotional stress and unnecessary, invasive medical treatment.
Other medical mistakes were false negatives; meaning due to faulty testing, serious medical conditions went undetected and people went untreated.
Examples of Medical Errors Made by Laboratory Developed Tests
Examples of false-positive testing in the FDA report included:
• Ovarian cancer screening and detection
• Lyme disease
• Whooping cough
Examples of false-negative testing (missed diagnosis) included:
• Breast cancer screening and detection
• Cervical cancer screening and detection
Sales estimates of 2015 North American laboratory developed tests and their medical devices are about $25 billion, and projected to grow to $29 billion by 2020.
Misdiagnoses that lead to the wrong treatment or no treatment are serious mistakes that can put lives in peril. If you were misdiagnosed or lost a loved one to an incorrect medical diagnosis, an attorney experienced in medical malpractice cases can investigate to identify all responsible parties and hold them accountable.
The choice of a lawyer is an important decision that should not be based solely on advertising.