FTA ...
Common LDTs today include tests for COVID-19, blood level tests and tests for drug abuse. While LDTs in the ’70’s were carried out by laboratory personnel with expertise, current-day tests now use high-tech instrumentation and software to generate results.
“Today’s LDTs are also more commonly manufactured with instruments or other components not legally marketed for clinical use and are more often used to inform or direct critical treatment decisions, to widely screen for common diseases, to predict personal risk of developing certain diseases, and to diagnose serious medical conditions such as cancer and heart disease,” the FDA said in its final rule on LDTs.
The FDA cited these factors when announcing the change.
“LDTs are being used more widely than ever before — for use in newborn screening, to help predict a person’s risk of cancer, or aid in diagnosing heart disease and Alzheimer’s. The agency cannot stand by while Americans continue to rely on results of these tests without assurance that they work,” FDA Commissioner Robert M. Califf said in a statement.
The announcement was welcomed by health groups.
The American Cancer Society called the change “a positive step toward ensuring uniform review of all tests intended for the same purpose.”
The move also drew some blowback, however. Sen. Bill Cassidy (R-La.), ranking member of the Senate Committee on Health, Education, Labor and Pensions, blasted the decision.
“The FDA does not have the authority to unilaterally increase its regulatory jurisdiction. This rule will undermine access to essential laboratory tests, increase health care costs, and ultimately harm patients,” Cassidy said in a statement.
“During the pandemic, we saw how too much government interference and red tape delays lifesaving care to Americans. Congress needs to take action to clarify the regulatory structure for diagnostic tests.”
I have utilized two of these tests, recently.
This is a travesty. If I want to spend my money on a new test, it is on me.
The FDA just like the entire government is USELESS and not to be trusted!!