COVID-19 roundup: FDA approves Abbott’s 5-minute test; plus Trump signs stimulus bill, WHO readies master protocol, CytoDyn mAb data and more
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FDA granted emergency approval Friday to a trio of diagnostics for COVID-19, including a molecular point-of-care test from Abbott that can detect COVID-19 in minutes. The approvals came as President Donald Trump signed a $2 trillion stimulus package into law and the WHO readied the start of its master protocol study.
The COVID-19 test from Abbott Laboratories (NYSE:ABT) can yield positive results in “as little as five minutes” and negative results in 13 minutes, according to the company. It will run on Abbott’s ID NOW platform, with the company making tests available next week to healthcare providers in U.S. urgent care settings. Abbott said it expects to ramp up manufacturing to deliver 50,000 tests per day.
The test amplifies viral sequences similarly to PCR, but dispenses with thermocycling all together. The company’s ID NOW device performs targeted sequence amplification at a constant temperature, and reads out via sequence-specific fluorescent probes (see “COVID-19 Diagnostic Tech Tableau”).
BGI Genomics Co. Ltd. (SZSE:300676) and Luminex Corp. (NASDAQ:LMNX) also received emergency use authorization (EUA) from FDA for their respective COVID-19 diagnostics.
BGI launched its test last week under new FDA guidelines that allowing distribution and use of tests while manufacturers prepare EUA requests (see “FDA Expanding U.S. COVID-19 Test Capacity”).
According to the company, its Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 can return results within three hours. The company has a daily manufacturing capacity of 600,000 reactions, and as of March 22, had produced a total of 4.7 million tests.
Luminex said its high-throughput NxTAG CoV Extended Panel can be run on its bead-based MAGPIX system to test 96 samples in about four hours. The company received $642,000 in funding from BARDA to develop the SARS-CoV-2 test.
President Trump signed the Coronavirus Aid, Relief, and Economic Security (CARES) Act shortly after the House of Representatives passed the measure, which appropriates $27 billion to HHS to develop countermeasures and vaccines against COVID-19 (see “Revamped Senate Stimulus Bill”).
Two organizations from the San Francisco Bay Area also committed R&D funding.
The Chan Zuckerberg Initiative (CZI) committed $25 million to the COVID-19 Therapeutics Accelerator, which the Bill & Melinda Gates Foundation, Wellcome Trust and Mastercard teamed up to invest $125 million in this month. The accelerator will focus on short-term COVID-19 solutions by identifying opportunities to repurpose agents that could be deployed rapidly, and on longer-term approaches such as developing new investigational drugs and antibody-based therapies (see “Gates, Wellcome Trust and Mastercard Commit $125M to COVID-19 Therapies”).
CZI said it will make $20 million available immediately, with $5 million available based on future needs.
Meanwhile, the California Institute for Regenerative Medicine’s board approved $5 million in research funds for regenerative medicine and stem cell approaches to a COVID-19 therapeutic.
WHO preps trial, a call for SOLIDARITY
The World Health Organization said that in Norway and Spain, the first patients will soon be enrolled in its COVID-19 master protocol SOLIDARITY trial, in which over 45 countries are contributing to.
WHO, which unveiled the trial last week, hopes the study will reduce the time needed to generate data on which therapies are most efficacious. The trial will start with four treatment arms: remdesivir from Gilead Sciences Inc. (NASDAQ:GILD); the combination of two HIV treatments, lopinavir and ritonavir; lopinavir and ritonavir plus interferon beta; and chloroquine. Treatments can be added or dropped in the future (see “WHO Launching Master Protocol for COVID-19 Therapies”).
As WHO is kicking off its trial, Costa Rica President Carlos Alvarado Quesada and Health Minister Daniel Salas Peraza have asked the organization to pool rights to technologies to detect, prevent, control and treat COVID-19.
In a letter to Director General Tedros Adhanom Ghebreyesus, the country’s leaders asked for a memorandum of understanding on the intent to share existing and future rights to COVID-19-related technologies, including regulatory test data, know-how, cell lines, copyrights and blueprints for manufacturing diagnostic tests, devices, drugs and vaccines. The pool, they said, should provide “free access or reasonable and affordable licensing terms” in all member countries.
The pair also asked the Global Observatory on Health R&D to create a database of COVID-19 R&D activity, including estimates of costs of clinical trials and the subsidies provided by governments and charities.
Early data for CytoDyn mAb
CytoDyn Inc. (OTCQX:CYDY) reported results from the first four patients given leronlimab as part of an emergency IND. The biotech’s companion diagnostic showed that after three days of therapy, the immune profile in all four patients approached normal levels, with significant decreases in IL-6 and TNFα.
CytoDyn thinks its CCR5 antagonist could block pro-inflammatory cytokines and thus prevent cytokine storms associated with COVID-19 infection, helping patients recover from the pulmonary inflammation that drives mortality and the need for ventilators.
A total of seven patients have been enrolled in the Phase II trial thus far in a medical center in New York City. CytoDyn shares rose $0.43 (46%) to $1.37 Friday.
Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.
CCR5 (CD195) - CC chemokine receptor 5
IL-6 - Interleukin-6
TNFα - Tumor necrosis factor alpha