COVID-19 update: gaps persist between U.S. test capacity rhetoric, reality; BARDA funds Hologic’s high-throughput assay

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COVID-19 testing capacity in the U.S. is ramping up slowly, but huge gaps remain between needs and capacity, and between government claims and reality.

Delays in creating test capacity caused by incompetence at CDC and poor decisions at FDA have contributed to the public health crisis, a BioCentury editor’s note contends (see “Coronavirus Crisis Calls for Competence, Clarity and Courage at the Top”).

Data collected by the American Enterprise Institute and posted on Twitter at @COVID2019tests indicates that labs in the U.S. were capable of testing about 7,840 patients on March 9. This includes about 3,900 diagnostic tests by public health labs; 1,500 by Laboratory Corp. of America Holdings (NYSE:LH); 1,000 by Quest Diagnostics Inc. (NYSE:DGX); 1,000 by the University of Washington Virology Lab; 400 by the Gates Foundation; and 40 by Northwell Health Labs, a non-profit lab in New York.

U.S. capacity is far lower than countries such as South Korea, where more than 60,000 tests were administered within a week of the first report of community transmission of COVID-19, or China, which is capable of producing and deploying over 1.6 million tests per week.

The AEI numbers are also a stark contrast to commitments made by Trump administration officials.

President Donald Trump and Vice President Michael Pence said last week that tests were available for any American who needed to be tested.

Nancy Messonnier, director of CDC’s National Center for Immunization and Respiratory Diseases, told reporters Monday that CDC had sent kits with a capacity of 75,000 tests to state public health labs. She did not say how many tests those labs can perform.

The difference between stocks of test kits and the ability of machines and personnel to conduct testing explains the differential between the thousands of kits CDC has shipped and the 3,900 tests AEI estimates public health labs can perform.

Testing is essential for guiding treatment of individual patients, as well as for public health containment and mitigation efforts.

BARDA backing for Hologic test

Hologic Inc. (NASDAQ:HOLX) and the U.S. government are collaborating to rush a rapid, high-throughput test for COVID-19 onto the U.S. market.

Hologic will receive $699,000 from HHS’s Biomedical Advanced Research and Development Authority to develop a COVID-19 test for use with the company’s Panther Fusion system.

HHS said the assay is the first COVID-19 product selected under a BARDA streamlined funding process.

Hologic’s COVID-19 test will be based on amplification -- via PCR or transcription-mediated amplification -- of SARS-CoV-2 genome sequences, and clinicians could receive results within three hours.

BARDA and Hologic predict that the “necessary development” to enable FDA to consider emergency use authorization will be completed in a matter of weeks.

Proof of concept with the system has already been described. On Feb. 28, Hannover Medical School researchers described in a Journal of Clinical Virology paper adaption of PCR protocols to detect SARS-CoV-2 using Hologic’s platform. The researchers had used inactivated viruses grown in cell culture for the study, and plan to validate the test on clinical samples.

Hologic’s Panther Fusion system, which is marketed in the U.S. and the EU, is capable of processing up to 1,000 tests in 24 hours.

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