FDA Approves Another At-Home COVID Test
The test from Abbott produces results in 15 minutes. In an ongoing study, the test accurately produced positive results about 92% of the time and correctly returned negative tests 100% of the time, the company said.
USA Today:
FDA Clears A New Abbott Home Test To Detect The COVID-19 Virus
A day after the U.S. Food and Drug Administration authorized the nation's first home COVID-19 test, the agency on Wednesday cleared a second home test made by Abbott Laboratories. Abbott said the rapid BinaxNow home test will cost $25 and be available through a telehealth provider, eMed, which will determine whether a person is eligible. Only people with COVID-19 symptoms can get the home test. (Alltucker, 12/16)
Bloomberg:
Abbott’s $25 Rapid Virus Test Cleared For At-Home Use
Abbott Laboratories won U.S. authorization for a rapid Covid-19 test that costs $25 and can be used at home, a new accessible option from the manufacturer after months of obstacles to screening access in the country. The emergency clearance from the Food and Drug Administration opens a new market for Abbott’s BinaxNOW, a single-use swab-collected test that produces results in 15 minutes. Until now, the test had been administered by health-care providers. Abbott is partnered with a service to remotely prescribe the screening. ... The Abbott news follows the FDA’s clearance of the first at-home, over-the-counter Covid-19 test on Tuesday from East Brisbane, Australia-based Ellume. (Court, 12/16)
Boston Globe:
Harvard Professor: New At-Home Coronavirus Test Is A ‘Major Boon’ — But More Need To Be Approved
A Harvard professor who has been an outspoken advocate for cheap, rapid, at-home coronavirus testing hailed a new test that will be sold over the counter and can provide results to the user in about 15 minutes. The new test, made by Australian company Ellume, is a “major boon,” said Dr. Michael Mina, a professor at the T.H. Chan School of Public Health. Mina is among a group of experts who have argued that at-home testing could offer a way out of the pandemic. “An over-the-counter rapid test is a tremendous advance. It means that some people will have ready access to a much needed test to help know their status, without having to go through a physician,” Mina said Tuesday in a statement. (Finucane, 12/16)
The Washington Post:
How Do Home Tests For Coronavirus Work? Where Can I Get One?
For months, consumers have been able to buy home collection kits. But these are quite different from the new rapid home tests. The older home collection kits usually sell for $110 to $150 at retailers such as Costco, Walmart or at testing companies, including LabCorp and Quest Diagnostics. With collection kits, people swab their nostrils or spit saliva into a vial and send the sample for processing at a lab. The companies say it takes 24 to 48 hours to get results. What makes the three newly authorized home tests different? Users swab their nostrils and can get results in roughly 15 minutes from the single-use tests. (Wan, 12/16)
In other pharmaceutical industry news —
AP:
Senate Report: Opioid Industry Has Paid Advocacy Groups $65M
A bipartisan congressional investigation released Wednesday found that key players in the nation’s opioid industry have spent $65 million since 1997 funding nonprofits that advocate treating pain with medications, a strategy intended to boost the sale of prescription painkillers. The report from Sens. Chuck Grassley of Iowa and Ron Wyden of Oregon found the contributions continued in recent years, even as the industry’s practices and the toll of opioid addiction came under greater scrutiny. (Mulvihill, 12/17)
Stat:
Sage Names Former Alnylam Exec Barry Greene As Its New CEO
Sage Therapeutics is making a significant leadership change, hiring Barry Greene, the recently departed president of Alnylam Pharmaceuticals, as the biotech’s new chief executive officer. Jeff Jonas, Sage’s CEO since 2013, will remain with the company as chief innovation officer. The official CEO handoff took place on Tuesday and was made public on Wednesday morning. (Feuerstein, 12/16)
Stat:
Ethics: A Necessary Ingredient In The Biotech Recipe For Success
Even as hopes soar that soon-to-be-distributed Covid-19 vaccines will help quench the global coronavirus pandemic, there are still concerns about the rapid speed with which these vaccines were developed. And with some estimates suggesting that the global Covid-19 vaccine market could surpass $40 billion in 2021 alone, this scrutiny is likely to continue. (Kaplan, 12/17)
