AACC Commends Congress for Including Funding for Testing Improvements in the Latest Coronavirus Relief Package

AACC commends Congress for responding to the concerns of the clinical laboratory community and including $25 billion in the Paycheck Protection Program and Health Care Enhancement Act that is broadly marked for expanding the nation’s coronavirus testing capacity.

The Federal Government Must Act on Supply Chains to Enable COVID-19 Testing in High Volumes

With shortages of test components and swabs, labs still face huge obstacles to COVID-19 testing. With new White House guidelines reliant on more testing, AACC is urging the administration to find and coordinate resources so lab experts can do their jobs.

The Need for FDA to Regulate Poorly Performing Commercial COVID-19 Tests Should Not Hinder Laboratory-Developed Tests

In the wake of FDA’s decision to loosen its emergency use authorization criteria for COVID-19 tests, reports have now been surfacing about unreliable commercial COVID-19 serological tests. While this is a major concern, AACC wants to emphasize that these problematic commercial tests are not the same as laboratory-developed tests–and that we still strongly support FDA’s decision to step back from regulating lab-developed tests for COVID-19.

Coriell Institute for Medical Research Fills Gaps in COVID-19 Testing Materials Supply

Answering the growing need for additional testing, and in direct response to shortages encountered in testing kit supply pipelines, the Coriell Institute for Medical Research is now offering services to create viral testing collection tubes containing different media and/or buffer formulations, for use in COVID-19 testing kits. Coriell is also exploring the feasibility of saliva as a means for testing for the new coronavirus.

BIDMC physician-scientists spearhead effort to address nationwide COVID-19 testing swab shortage

As the numbers of patients with confirmed and suspected COVID-19 in the United States continue to rise exponentially, physician-researchers at Beth Israel Deaconess Medical Center (BIDMC), part of Beth Israel Lahey Health, launched a collaborative and open-source effort to address the shortage of swabs that is hampering the nation’s ability to test for and track the spread of the virus. The team’s mission is to catalyze the development and clinical validation of novel designs for swabs for COVID-19 testing that can be manufactured quickly and in large numbers.

AACC Applauds the Senate for Updating Its Legislation to Ensure that All Patients Have Access to COVID-19 Testing

AACC applauds the U.S. Senate for responding to the concerns of the clinical laboratory community and revising the Coronavirus Aid, Relief, and Economic Security (CARES) Act to ensure that it provides insurance coverage for all COVID-19 tests, regardless of whether or not they are performed under an FDA emergency use authorization (EUA).

Rutgers New Jersey Medical School Research Team Participates in First External Evaluation of Groundbreaking Covid-19 Test

Rutgers University researchers have completed the first evaluation of a new rapid COVID-19 test, which was approved for emergency use by the Food and Drug Administration (FDA). The test, developed by CEPHEID, a U.S. molecular diagnostics company is very fast and easy to perform without the need for a centralized laboratory.

AACC Launches Directory of U.S. Labs That Are Performing COVID-19 Testing

To facilitate rapid identification of COVID-19 cases, AACC has launched a directory of U.S. clinical laboratories that are, or will be, performing testing for SARS-CoV-2, the virus that causes COVID-19. This directory is designed to help healthcare providers quickly find laboratories that can diagnose patients suspected to have COVID-19.

AACC Urges Congress to Ensure That All COVID-19 Tests Are Covered by Insurance Now That FDA Has Released Guidance That Will Expand Testing Access

On March 16, FDA updated its guidance on COVID-19 testing to allow clinical labs to create and perform COVID-19 tests without pursuing FDA emergency use authorization (EUA). AACC commends this decision, which will help speed the expansion of COVID-19 testing at this crucial time. However, the association remains concerned that the Families First Coronavirus Response Act does not provide coverage for COVID-19 tests unless the tests are performed under an EUA. AACC urges Congress to rectify this problem before passing the bill so that all patients will have access to coronavirus testing.

Families First Coronavirus Response Act Would Prohibit Insurers from Paying for Some COVID-19 Tests

AACC greatly values the work that the U.S. House of Representatives has done to support American families in the midst of the coronavirus outbreak and is supportive of the goals of H.R. 6201, the Families First Coronavirus Response Act. However, we are concerned that the language as currently drafted does not provide coverage for COVID-19 tests performed prior to those tests receiving Emergency Use Authorization (EUA) from the Food & Drug Administration (FDA).