Where Is the FDA When Labs Need It Most?

LET’S START WITH AN ESSENTIAL FACT: in the management of almost every outbreak of a novel infectious disease, clinical laboratory tests will be essential in diagnosis of the disease, in monitoring the progress of an infected patient, and in determining if, once cured, a patient has immunity to that disease.

Next, let’s recognize another basic fact: clinical lab testing is just 3¢ on the healthcare dollar. The healthcare system gets incredible value when lab tests are used appropriately by physicians.

Unfortunately, since the first days of the SARS-CoV-2 outbreak, it seems federal officials at different agencies and departments are ignoring the truths of  the two facts presented above. Their actions involving clinical lab testing have been regularly criticized and second-guessed almost daily in the national news cycle.

It is easy to argue that, following the first COVID-19 patient diagnosed in the United States in late January, the directives and decisions of multiple federal agencies have stymied the efforts of clinical laboratories in the United States to quickly step up with large volumes of SARS-CoV-2 tests that can help authorities better manage the COVID-19 pandemic.

First it was the CDC’s distribution of a molecular COVID-19 test in February that was defective. At about the same time, federal authorities issued directives that prevented some of the nation’s best labs from speedily developing COVID-19 tests as LDTs and using them for patient care.

It should not be overlooked that Medicare officials contributed their own hurdles to larger volumes of COVID-19 testing when the Centers for Medicare and Medicaid Services set reimbursement for molecular COVID-19 at just $51, substantially below what it cost even the nation’s billion-dollar labs to run such tests. After a few weeks of negative national press coverage, CMS raised the price of such tests to $100.

For the FDA, on March 16, it issued relaxed rules for COVID-19 serological tests. Within weeks, more than 200 such tests were listed on the FDA’s website and it was forced to retreat. It issued tighter rules on May 4 that reduced the number of serology tests listed on its website. But now comes information from the agency itself that its own assessment of the first 11 COVID-19 serology tests showed that eight tests did not meet its performance requirements.