Last month, journalists from the New England Center for Investigative Reporting raised serious questions about prenatal genetic screening tests, saying physicians and patients may not fully understand the results of these tests for fetal abnormalities.
In their reporting, the journalists exposed a symptom of what may be a bigger problem: the proliferation of genetic tests without a full understanding about what such testing can and cannot do. Even health insurers have struggled to understand how to pay for new genetic tests.
The stories also pointed out that federal regulators are wrestling with how to classify genetic tests. Many of these tests fall into the category of what pathologists call lab-developed tests or LDTs. These tests are not regulated by the FDA, as the NECIR journalists reported. In October, the FDA proposed regulating these tests as medical devices and clinical laboratories are pushing back, saying such regulations could interfere with the practice of medicine.
We’ll address these issues one at time. Continue reading