Markey wants COVID-19 test-makers to lower prices

Sen. Ed Markey, D-Massachusetts

Sen. Ed Markey, D-Massachusetts, has sent letters to CEOs of at-home COVID-19 test-makers, asking why tests are selling for as much as $12 apiece.

In a letter sent today to Abbott CEO Robert Ford, for example, Markey cited a Reuters story from October 2021 in which British test-maker Mologic said that rapid antigen tests can cost as little as $2 apiece to manufacture. “Yet, U.S. consumers face costs of $12 or more for each at-home rapid COVID-19 antigen test. As we face an unprecedented wave of COVID cases, manufacturers and retailers must do more to ensure consumers see reasonable prices for at-home tests.”

Markey made similar points to top leadership at BD, Access Bio, Quidel, Acon Laboratories, Celltrion USA, Ellume Health, iHealth Labs, InBios International and OraSure Technologies.

Get the full story on our sister site Medical Design & Outsourcing. 

Read more
  • 0

Democratic senator wants COVID-19 test-makers to lower prices

Sen. Ed Markey (D-Massachusetts)

Sen. Ed Markey, D-Massachusetts, has sent letters to CEOs of at-home COVID-19 test-makers, asking why tests are selling for as much as $12 apiece.

In a letter sent today to Abbott CEO Robert Ford, for example, Markey cited a Reuters story from October 2021 in which British test-maker Mologic said that rapid antigen tests can cost as little as $2 apiece to manufacture. “Yet, U.S. consumers face costs of $12 or more for each at-home rapid COVID-19 antigen test. As we face an unprecedented wave of COVID cases, manufacturers and retailers must do more to ensure consumers see reasonable prices for at-home tests.”

Markey made similar points to top leadership at BD, Access Bio, Quidel, Acon Laboratories, Celltrion USA, Ellume Health, iHealth Labs, InBios International and OraSure Technologies.

The letters could carry some weight because Markey is not only …

Read more
  • 0

TIME recognizes Abbott among this year’s 100 best inventions

The BinaxNow COVID-19 Ag Card [Image courtesy of Abbott]Abbott (NYSE:ABT) was among a series of medtech companies to receive recognition from TIME in its list of 2021’s best inventions.

The list of the year’s top inventions included Abbott’s innovations twice, with a nod to its NeuroSphere Virtual Clinic and its at-home COVID-19 testing offerings.

Get the full story at our sister site, Medical Design & Outsourcing.

Read more
  • 0

TIME recognizes Abbott among this year’s 100 best inventions

The BinaxNow COVID-19 Ag Card [Image courtesy of Abbott]

Abbott (NYSE:ABT) was among a series of medtech companies to receive recognition from TIME in its list of 2021’s best inventions.

The list of the year’s top inventions included Abbott’s innovations twice, with a nod to its NeuroSphere Virtual Clinic and its at-home COVID-19 testing offerings.

NeuroSphere Virtual Clinic allows physicians to speak to patients over a video app and to remotely adjust Abbott’s implanted neuromodulation devices. The platform won FDA approval in March and Time reported that the company plans to expand availability of NeuroSphere Virtual Clinic soon.

Abbott’s BinaxNOW was one of several at-home, over-the-counter COVID-19 tests to receive a mention from Time as the news organization recognized the tests for aiding in efforts to prevent the spread of the virus.

In a post on LinkedI…

Read more
  • 0

Ellume’s at-home COVID-19 tests recall expands to more than 2 million

[Image courtesy of Ellume]The FDA announced this week that a recall of Ellume at-home COVID-19 tests at risk of false positives has expanded to include more than 2 million.

The Class I recall had only been in the hundreds of thousands of kits when first announced in October.

The Australian company has stressed that the reliability of negative results is unaffected by the problem.

“Ellume has investigated the issue, identified the root cause, implemented additional controls, and we are already producing and shipping new product to the U.S.,” a company representative told the New York Times.

FDA, however, still considers the recall serious because false positives could delay diagnosis and treatment for whatever is actually ailing people — and could cause them the undergo unneeded COVID-19 therapies.

People with false positives could also unnecessarily isolate themselves or miss work.

FDA said it has received 35 reports of false-positive r…

Read more
  • 0

5 at-home COVID-19 diagnostic tests you should know

The wait for a completely at-home COVID-19 test ended in November when the FDA authorized the first ones that enabled people to obtain samples and results at home.

The agency has authorized five at-home COVID-19 testing kits for emergency use since the beginning of the pandemic. The kits are made to take a sample using self-administered nasal swabs. The results are delivered in less than an hour using technology similar to pregnancy tests, revealing positive or negative results.

However, there is a risk of false positives and negatives using rapid antigen tests at home, the FDA has warned. The agency said in a Dec. 15 press release that patients without symptoms who present a positive test should be treated as “presumptively positive” until it can be confirmed by another test. Patients who test negative and experience COVID-like symptoms are advised to follow up with their healthcare providers as a negative result does not rule out a SARS-CoV-2 infection.

<…
Read more
  • 0

5 at-home COVID-19 diagnostic tests you should know

[Image from unsplash.com]

A year into the COVID-19 pandemic, the wait for a completely at-home COVID-19 test ended when the FDA authorized the first ones in November to enable people to obtain samples and results at home.

The FDA has authorized five at-home COVID-19 testing kits for emergency use since the beginning of the pandemic. The kits are made to take a sample using self-administered nasal swabs. The results are delivered in less than an hour using technology similar to pregnancy tests, revealing positive or negative results.

However, there is a risk of false positives and negatives using rapid antigen tests at home, the FDA has warned. The agency said in a Dec. 15 press release that patients without symptoms who present a positive test should be treated as “presumptively positive” until it can be confirmed by another test. Patients who test negative and experience COVID-like symptoms …

Read more
  • 0

Quidel wins FDA nod for at-home antigen test

The FDA issued an emergency use authorization today for the Quidel Corp. (NSDW:QDEL) QuickVue At-Home COVID-19 test, another antigen test to rapidly collect and test samples at home, without needing to send a sample to a laboratory for analysis.

The QuickVue At-Home COVID-19 test is authorized for prescription home use with self-collected anterior nasal swabs from people ages 14 and older or children ages 8 and older with swabs collected by an adult. The test is authorized for those suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.

“The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said in a news release. “The QuickVue At-Home COVID-19 test is another example of the FDA working with test developers to bring important diagnostics to the public.”

In February…

Read more
  • 0

FDA issues mea culpa for early COVID-19 serology test nods

(Image by the National Cancer Institute on Unsplash)

Early in the pandemic, when the numbers of asymptomatic COVID-19 cases were mounting, officials at the FDA decided to authorize the use of serology tests that laboratories had validated but that the agency hadn’t actually reviewed.

Now two FDA officials are admitting that this was a mistake, but one the agency has learned from. In an article published in the New England Journal of Medicine, two top officials of the FDA’s Center for Devices and Radiological Health (CDRH) said that the agency was trying to slow the spread of SARS-CoV-2, the virus that causes COVID-19, by using the results of serology tests to screen for antibodies for the virus.

Get the full story on our sister site, Medical Design & Outsourcing.

Read more
  • 0

Biden administration orders home COVID-19 tests

The U.S. Defense Dept. announced today that it awarded Ellume $231.8 to onshore production capacity of its Ellume COVID-19 home test.

In coordination with the U.S. Dept. of Health and Human Services (HHS), the DoD contract is an industrial base expansion to allow Ellume to increase the production capacity of its home test by 640,000 tests per day by December 2021.

The expansion includes the procurement of 8.5 million tests to be distributed across the U.S. in accordance with the National Strategy for the COVID-19 Response and Pandemic Preparedness policy established January 21, 2021, according to a news release.

Valencia, Calif.-based Ellume’s COVID-19 home test is the first FDA-authorized fully at-home diagnostic for detecting symptomatic or asymptomatic COVID-19, having received emergency use authorization (EUA) in December. The test’s development was supported by the National Institutes of Health’s (NIH) Rapid Acceleration of Diagnos…

Read more
  • 0