AACC: LDTs play crucial role in patient care

By Rebekah Moan, LabPulse.com contributing writer

October 16, 2020 -- Laboratory-developed tests (LDTs) act as a bridge between laboratories and physicians. Without LDTs, patient care is neither optimal nor personalized, according to a congressional briefing from the American Association for Clinical Chemistry (AACC) on October 14.

Furthermore, adding regulation by the U.S. Food and Drug Administration (FDA) would be duplicative, burdensome, and could stymie the ability of labs to respond quickly to new diseases like COVID-19.

LDTs are noncommercial tests that labs create and use internally. They are regulated by the U.S. Centers for Medicare and Medicaid Services (CMS) and the CLIA, but over the last several years, the FDA has said it should regulate LDTs.

However, the AACC asserts adding another regulatory layer would curtail labs' ability to swiftly develop new tests. The U.S. Department of Health and Human Services has weighed in and in August said the FDA does not have authority to regulate these tests without formal notice-and-comment rulemaking.

"Moving forward, it is vital that any future changes in healthcare policy and regulation follow suit and continue to ensure patient access to these essential tests," the AACC said in a press release to accompany the congressional briefing.

The importance of LDTs

COVID-19 is highlighting just how crucial LDTs truly are, the AACC said. At the start of the pandemic, no commercial coronavirus tests were on the market, so the World Health Organization (WHO) and U.S. Centers for Disease Control and Prevention (CDC) stepped in. That meant patients had access to COVID-19 tests much faster than if they had to wait for a commercial test to become available.

However, the pandemic is just one example illustrating the importance of LDTs, said Dennis Dietzen, PhD, a professor of pathology, immunology, and pediatrics at Washington University School of Medicine and medical director of laboratory services at the St. Louis Children's Hospital, during the AACC briefing.

Other instances where LDTs play a role are for rare conditions that commercial entities don't invest in but for which tests are still needed. Also, LDTs are well-suited for when test results are desired immediately, for rapidly developing new diseases, or to test new disease biomarkers, Dietzen said.

LDTs are not only beneficial for patients but also for healthcare facilities, according to Dr. Carolee Estelle, interim chief of infection prevention for Parkland Health & Hospital System in Dallas. For instance, if it's known a patient doesn't have COVID-19, hospital staff can save their personal protective equipment (PPE) gear for patients that do.

LDTs can also help avoid bottlenecks in the emergency room because they help hospital staff understand where to situate patients. On top of that, having rapid testing available means the workforce is preserved and protected -- they know if they have COVID-19, and if they contract it, when it's safe for them to return to work.

"In the end, patients end up suffering unnecessarily without LDTs," Dietzen said. "This is the place where laboratorians thrive ... We know about the disease state. We know what clinicians need and we know how to build these things."

HHS: FDA review not needed for coronavirus LDTs
Laboratory-developed tests (LDTs) to diagnose whether patients are infected with the SARS-CoV-2 virus will not have to undergo review by the U.S. Food...
AACC responds to reports of bad blood tests for coronavirus
The American Association for Clinical Chemistry (AACC) has acknowledged problems with some commercial serology tests for the novel coronavirus, while...
It's time to recruit research labs in the COVID-19 fight
Careful incorporation of research laboratories into the COVID-19 testing effort could increase capacity in the U.S. and globally, writes molecular diagnostics...
Molecular testing and COVID-19: Where are we now?
As the COVID-19 pandemic accelerates, attention has been focused on how to effectively scale up the diagnostic testing that is needed to correctly manage...
VITAL Act steps in on regulation of lab-developed tests
U.S. legislators are considering the Verified Innovative Testing in American Laboratories (VITAL) Act of 2020, which clarifies federal rules governing...

Copyright © 2020 LabPulse.com

Last Updated ls 10/15/2020 1:33:13 PM



Register below for our weekly Letter from the Editor to receive the latest Clinical Lab news and insights.
Email
Subscribe Today
Do you want to be a Microbiology Insider?

When LabPulse gets hot new information, our Insiders are the first to find out. Stay current in today's competitive market by receiving our exclusive free email updates.

Yes, Keep Me Current