San Diego’s Cue Health had the first FDA-approved home COVID-19 test. Now the agency says to throw them out. – San Diego Union-Tribune
San Diego’s Cue Health had the first FDA-approved home COVID-19 test. Now the agency says to throw them out. – San Diego Union-Tribune
Author: Natallie Rocha
Published on: 2024-05-15 08:30:04
Source: Technology – San Diego Union-Tribune
Disclaimer:All rights are owned by the respective creators. No copyright infringement is intended.
The U.S. Food and Drug Administration told consumers Monday to throw out any at-home COVID-19 tests made by San Diego biotech Cue Health, because they could give users false results.
Early in the pandemic, the FDA gave Cue Health the industry’s first emergency use authorization, a fast-track approval, for its sleek, 15-minute molecular COVID-19 test. Last year, the San Diego-based company also became the first at-home coronavirus test to receive full regular-use clearance.
Less than a year later, the FDA is changing its tune.
An FDA inspection of Cue Health facilities late last year found that the company had modified its COVID-19 tests in a way that reduced its reliability to detect the virus. The directive from the nation’s top drug regulator tells at-home test users, caregivers and health care providers “not to use Cue Health’s COVID-19 Tests due to this increased risk of false results.”
“Do not use any Cue Health COVID-19 Tests for Home and (over the counter) Use that you may still have,” the FDA statement said. “Dispose of the entire test cartridge in the household trash.”
It comes days after the agency issued a warning letter to Cue Health’s leadership ordering the company to stop selling these COVID-19 tests. The May 9 letter addressed to Cue Health CEO Clint Sever outlines issues found during the inspection. It says the firm changed its product without telling the FDA and as a result, the tests aren’t as accurate as they should be to meet safety standards.
“Your firm should take prompt action to address any violations identified in this letter,” the FDA said in the warning letter. “Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.”
San Diego’s Cue Health, maker of fast COVID-19 tests used by the military, NBA lands $200M in IPOCue Health issued a statement earlier this week that said it had received the FDA warning letter and was “currently evaluating the letter and determining its response, with more information to follow in the next few days.”
On Thursday Cue said in an email to the Union-Tribune that it will “voluntarily and temporarily pause sales and distribution of its currently marketed EUA COVID-19 Test Cartridge, in light of the FDA warning letter.” The company also said it is “actively working with the FDA to quickly resolve the issues that were raised and is working with customers to reach appropriate resolutions. We are engaged with the FDA regarding future plans for distributing tests, and will provide an update in the near future.”
During the coronavirus pandemic, Cue was a major beneficiary of the government’s multi-million dollar push to fund rapid testing, especially with home test kits. The San Diego-based company was also bolstered by the private sector through lucrative partnerships with the NBA and major corporations like Google.
The company, which was founded in 2010, soared into the public market with a $200 million IPO in 2021, fueled by its first commercial product, the COVID-19 test.
Cue made efforts to expand its diagnostic services into at-home tests for sexual health, heart health and metabolic tests where samples are sent to a lab and the results go straight to the user’s phone. Cue also enabled its smartphone app to connect users to telehealth services.
The company’s only commercial diagnostic tests on the market are its COVID-19 and mpox, previously known as monkeypox, tests.
The orders from the FDA spell trouble for a company that was already navigating rocky financial terrain.
This San Diego maker of COVID-19 tests is laying off half its workforceThe steep decline in demand for COVID-19 tests and the drop off in government-funded programs have left Cue and other diagnostic test companies scrambling to preserve money.
Earlier this month, Cue Health said it is laying off half its global workforce, or 230 employees, to reduce costs and focus on its core technology. This is the third round of layoffs at Cue this year.
Facing pressure from investors, Cue Health also replaced its longtime CEO and co-founder, Ayub Khattak. Additionally, last month, Cue’s chief financial officer Aasim Javed resigned.
Amid the leadership shakeup, Cue’s board also initiated a strategic review of its options, including the potential sale of the company.
Cue Health was scheduled to report its first quarter financial earnings on Monday, but the company did not do so. It is not clear when these results will be published.
Cue reported to the SEC Thursday that it is unable to meet the financial regulator’s filing deadline of May 15 or its extension period of five days due to the company’s workforce reductions. Cue Health also reported that two board members — former CEO Khattak and Rishi Reddy of Tarsadia Investments — resigned this week.
Reddy was appointed to the board in February as part of a cooperation agreement between Cue and Tarsadia after the investment firm sent company leaders a letter on the behalf of shareholders expressing discontent about its declining value.
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