Quidel Corp. Archives - Medical Design Sourcing

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…

Quidel opens new COVID-19 antigen test factory in Calif.

Quidel Corp. (NSDW:QDEL) yesterday said it has opened a manufacturing facility in Carlsbad, Calif. to produce its QuickVue line of COVID-19 rapid antigen tests.

The new 128,000 sq. ft facility will become the San Diego-based company’s highest-volume production plant. It will begin operations during the second half of 2021 with a goal of producing 600 million QuickVue SARS rapid antigen tests per year to detect and diagnose COVID-19 infections.

Quidel plans to install multiple manufacturing lines at the new facility and will hire approximately 400 new employees to scale production from 50 million QuickVue tests per year to 50 million tests per month, including non-COVID-19 diagnostic assays that are in-market or under development.

“From the first days of the pandemic, Quidel has stepped up to meet the COVID-19 challenge head-on with innovative diagnostic technologies to detect coronavirus infections and expanded manufacturing to democratize access t…

BD touts study of antigen test over molecular test for identifying infectious people

Becton Dickinson (NYSE:BDX) is touting the results of a small, in-house study of its Veritor Plus antigen test over molecular (PCR) tests to indicate whether an infected person is more likely able to spread SARS-CoV-2.

The peer-reviewed study compared antigen and PCR test results to positive results using a viral cell culture test. Viral growth in the cell culture test indicates the presence of live virus in the patient sample, which may indicate the presence of infectious virus at the time the sample was taken. If no growth is present in the viral cell culture test, it is likely that there wasn’t enough viable virus for the patient to be contagious at the time the sample was taken, according to BD. The study was published in Clinical Infectious Diseases.

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

MedTech 100 roundup: Up-and-down week for industry

Medtech stocks highlighted the topsy-turvy nature of the market last week, but ultimately finished the seven days nearly unchanged.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.77 points at the end of last week (Aug. 14). Overall, medtech stocks saw a 0.13% increase from the 89.65-point total at the same time a week prior (Aug. 7).

On Aug. 13, the index reached 90.4 points, a total that nearly poked past the previous mid-pandemic high (90.45), which came just last week.

The most recent high mark represents just a -2.1% dip from the Feb. 19 high point of 92.32, while the tally at the end of the week marks a -2.8% decrease from that pre-pandemic high.

Meanwhile, the S&P 500 Index saw a 0.64% increase from Aug. 7 to Aug. 14, and the Dow Jones Index fared even better, rising 1.8% over the same period of time.

Medtech’s lowest point during the COVID-19 pandemic remains at …

Report: BD, Quidel struggle to supply antigen tests for COVID-19

(Image from the CDC)

Becton Dickinson (NYSE:BDX) and Quidel are struggling to fulfill orders for rapid COVID-19 antigen tests as the virus continues to spread, according to a report in the Wall Street Journal.

The newspaper reported today that the two companies, which are the only ones that have FDA emergency use authorizations to sell the rapid diagnostics, cannot keep up with demand and that the Department of Defense is preparing another major order. The companies sell the analyzer equipment to perform the tests as well as the actual tests. Quidel told the Journal that it is having trouble meeting demand for analyzers, while BD is struggling to produce enough tests, the newspaper reported. Neither company immediately responded to requests for comment.

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

States band together to purchase BD, Quidel antigen tests for COVID-19

Seven U.S. states have formed an interstate compact with the Rockefeller Foundation to expand the use of rapid point-of-care antigen tests to better manage the COVID-19 pandemic.

The compact — announced yesterday by a bipartisan group of governors leading the states — includes Louisiana, Ohio, Maryland, Massachusetts, Michigan, North Carolina and Virginia.

The idea is that by working together, the states are demonstrating to private manufacturers that there is significant demand to scale up the production of antigen tests. Now that the compact is in place, the states are in discussions with Becton Dickinson (NYSE:BDX) and Quidel to purchase 500,000 tests per state, for a total of 3.5 million tests.

“With severe shortages and delays in testing and the federal administration attempting to cut funding for testing, the states are banding together to acquire millions of faster tests to help save lives and slow the spread of COVID-19,” said Maryland Gov. Lar…

NIH puts $249m into new COVID-19 tests

Quidel’s Sofia 2 point-of-care COVID-19 test. (Image from Quidel/NIH)

The National Institutes of Health (NIH) announced today that it is investing $248.7 million in new technologies to address challenges with COVID-19 testing.

The “Rapid Acceleration of Diagnostics” (RADx) initiative awarded contracts to seven biomedical diagnostic companies to support lab-based and point-of-care tests that could significantly increase the number, type and availability of tests by millions per week as early as September 2020, according to a news release.

Four of the selected technologies offer innovations in laboratory-based testing, including next-generation sequencing, CRISPR and integrated microfluidic chips for increasing testing capacity and throughput while reducing the time needed to receive results.

Remaining are three point-of-care technologies that provide nucleic acid and viral anti…