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AACC Asks Congress to Wait on LDT Regulation During Coronavirus Outbreak

Federal Insider: April 2020

AACC called on lawmakers to pause consideration of a bill that would expand Food and Drug Administration (FDA) regulation of laboratory-developed tests (LDTs) until its full effects on the healthcare system can be evaluated. House and Senate lawmakers introduced the VALID Act in March. The bill would give FDA expansive new powers to regulate LDTs and would require premarket certification or approval depending on FDA’s assessment of a test’s risk. According to AACC, the bill would add costly and duplicative federal regulations to testing already regulated by the Centers for Medicare and Medicaid Services.

The bill also would affect FDA’s emergency use authorization (EUA) authority. When the novel coronavirus disease (COVID-19) outbreak was declared a public health emergency, current law required that all coronavirus tests receive an EUA from FDA, a cumbersome barrier that delayed laboratories in developing COVID-19 testing.

In response to concerns from AACC and the clinical laboratory community, FDA initially amended its EUA requirements to allow all qualified labs to develop and perform coronavirus tests prior to obtaining an EUA, as long as they submitted an EUA request to FDA within 15 days of the tests’ launch. As pressure mounted on the agency to do more to alleviate the COVID-19 testing shortage in the U.S., FDA followed this by dropping the EUA requirement altogether for those labs located in states willing to assume oversight of testing.

The lawmakers sponsoring the VALID have framed it as a benefit for patients by making permanent this decision by FDA. However, the rest of the bill introduces new and redundant regulatory hurdles for labs. This would create new barriers for developing testing for everyday patient care outside of emergencies.

AACC also successfully ensured that a separate bill, the Families First Coronavirus Response Act, would require insurance coverage for all COVID-19 testing. An initial draft of the legislation only required coverage for tests that already had received an EUA. However, given that labs no longer have to pursue an EUA for COVID-19 tests under FDA’s new guidelines, this provision could have led to surprise medical bills for patients as labs worked to quickly ramp up testing.

NIH Announces $1 Million Competition for Global Disease Diagnostics

The National Institutes of Health (NIH) is partnering with the Bill & Melinda Gates Foundation to launch a $1 million Technology Accelerator Challenge that aims to spur development of non-invasive, handheld, digital technologies that will help combat diseases with high global and public health impact. The challenge is focused on sickle cell disease, malaria, and anemia. NIH is looking for technology that could rapidly screen large populations as well as provide physicians with a tool to personalize therapy for individual patients.

NIH will award up to $500,000 for a top finalist and several smaller awards to five semi-finalists. The Gates Foundation will separately review winners and honorable mentions and consider them for follow-on support, including a grant of up to $500,000.

Current tests for sickle cell disease, malaria, and anemia can be challenging to deliver in low-resource settings, particularly at the population level, due to cost, invasiveness, and the expertise required to administer them, according to NIH.

“While this challenge is not constrained to any specific technology, the inspiration for it comes from the widespread availability of mobile phones and the potential for mobile phone-linked sensor technologies to non-invasively detect changes in the blood and blood vessels associated with these treatable diseases,” said Bruce Tromberg, PhD, director of NIH’s National Institute of Biomedical Imaging and Bioengineering.

The challenge will accept applications through June 2, 2020.