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HHS, DoD Announce $12.7M Contract to Increase COVID-19 Testing
The federal departments will boost the production of two COVID-19 tests to 400,000 units per week by May 2021, which is 20 times the current output.
HHS and the Department of Defense (DoD) jointly announced a $12.7 million contract to increase domestic production for two rapid point-of-care COVID-19 tests.
The contract is with InBios International Inc. of Seattle and it will enable the medical technology manufacturer to boost production of either or both tests to 400,000 units per week by May 2021. This is 20 times the facility’s current output, HHS said.
The first test, SCoV-2-Ag Detection Kit, uncovers current infections by identifying antigens of the virus in a nose swab sample. The second test, the SCoV-2 Detects IgM/IgG Kit, detects antibodies for COVID-19 via finger prick.
The contract is part of a collaboration between Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, and several other federal agencies, including the HHS Office of the Assistant Secretary for Health, the Department of Defense Assisted Acquisition Cell, and the Department of the Air Force’s Acquisition COVID-19 Task Force.
BARDA supported development of the InBios SCoV-2 Detect IgM/IgG Kit and funded the contract under the Paycheck Protection Program and Health Care Enhancement Act, HHS noted.
So far, BARDA-supported partners have shipped more than 50 million tests to healthcare providers across the US.
The InBios SCoV-2 Detect IgM/IgG kit is one of 33 COVID-19 diagnostic tests in BARDA’s development portfolio.
Of these 33 diagnostic tests, 16 have received FDA emergency use authorization, including Siemens Healthineer’s Atellica COVID-19 antigen test and Luminex Corporation’s ARIES SARS-CoV-2 Assay.
Siemens’s Atellica antigen test received the first emergency use authorization for two of its COVID-19 tests at the end of July.
The tests, ADVIA Centaur COV2G and Atellica IM COV2G, are known as “semi quantitative” tests, which means they do not display precise measurement. Instead, the tests estimate the quantity of a patient’s antibodies produced against COVID-19.
Additionally, Luminex received FDA emergency use authorization for its ARIES SARS-CoV-2 Assay back in April, which allowed caregivers to determine the appropriate course of treatment for patients suspected of having COVID-19 within approximately two hours.
This emergency use authorization was the first of three given to Luminex’s for its individual COVID-19 tests.
Other essential potential COVID-19 treatments BARDA’s portfolio include Eli Lilly and Company’s antibody drug LY-CoV555 and AstraZeneca’s SARS-CoV-2 monoclonal antibody combination AZD7442.
In mid-October, HHS and DoD announced an agreement with AstraZeneca for the late-stage development and large-scale manufacturing of AZD7442.
The agreement is part of the Trump Administration’s Operation Warp Speed and will attempt to manufacture the monoclonal antibody cocktail, which is a combination of two monoclonal antibodies discovered by Vanderbilt University and licensed to AstraZeneca.
HHS noted that AZD7442 may be of particular use in certain groups, including individuals with compromised immune function, individuals over 80 years old, and individuals undergoing medical treatments that prevent them from receiving a COVID-19 vaccine.
If FDA authorizes the use of the antibody cocktail, the federal government will distribute the doses at no cost. But healthcare professionals could still charge for the cost of administering the product.
Last week, HHS and DoD also announced an agreement with Eli Lilly and Company to purchase the first doses of the company’s antibody therapeutic, LY-CoV555.
The organizations granted $375 million for an initial purchase of 300,000 doses of LY-CoV555 and the federal government can purchase up to 650,000 additional doses through the end of June 2021 for up to $812.5 million, HHS stated.
Eli Lilly and Company anticipates manufacturing up to 1 million doses of LY-CoV555 by the end of the year, with 100,000 doses ready to ship after authorization for use globally.
The doses of LY-CoV555 will become available for patient care if FDA authorizes use of the therapeutic and following agency guidance.
