Therma Bright Inc V.THRM

Health Canada Approves Quidel ’s Sofia ® SARS Antigen

[TheeRook]

Different test than  the AT-HOME test 


Health Canada Approves Quidel ’s Sofia ® SARS Antigen FIA Test for Screening of Asymptomatic Populations With Serial Testing

Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that its Sofia® SARS Antigen FIA is the first rapid antigen test to receive authorization from Health Canada for serial testing for the detection of active coronavirus infection in both symptomatic and asymptomatic populations.

 

The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms, or serial testing of asymptomatic populations using the Sofia SARS Antigen FIA test, at a minimum every 3 days/72 hours.

 

The Sofia® SARS Antigen FIA shows excellent performance within the first five days of the onset of symptoms, with positive results agreeing with PCR 96.7% of the time, and negative results agreeing 100% of the time, delivering confidence to physicians, healthcare workers and other customers within the professional segment. This new intended use claim allows the Sofia® SARS Antigen FIA to be used among asymptomatic individuals throughout Canada provided that individuals test at least every three days, or 72 hours. Routine testing by rapid antigen tests has shown to be effective in diagnosing COVID-19.1

 

“Quidel is proud to bring our most innovative and sensitive COVID-19 testing technologies to the Canadian market and make our tests as widely available as possible,” said Douglas Bryant, president and CEO of Quidel Corporation. “Health Canada’s approval opens the door to true democratization of the benefits of serial testing for both individuals experiencing symptoms and screening of people who may not have symptoms but are actively shedding the virus. Broadscale application of our Sofia® rapid antigen test for COVID-19 screening across Canada will catch asymptomatic cases early and limit virus spread and is an important tool to get Canadians back to work and getting the economy fully open again.”

 

1https://www.medrxiv.org/content/10.1101/2021.03.19.21253964v2

[moonball32]

That's good news for Canadians, another way to detect the virus, specialized use via healthcare providers, better than nothing, still not a rapid saliva test, it will help though.

[Smokey1958]

Once again there is so much more to the story ...not addressed by you. This test has not been approved by the FDA or HC ...it has been authorized ....a very different expectation. It has fallen under the umbrella of the EUA in the US and the same set of circumstances in Canada. The original test was authorized by HC last year and has done nothing since. Even the forward looking statements for this

[juniorbullalive]

This post has been removed in accordance with Community Policy

[Smokey1958]

What constitutes too many? How many test devices sold by each of these companies you speak of? Why so few? Big Pharma isn't even involved with test devices except Abbott Labs. The tests can be made for as little as $2.50. In fact they're trying to develop a vaccine for around $2.00.  So it's all about bringing the cost down to scale up the production based on AFFORDABILITY.

[stockmonster6]

The $1 predicted profit margin alluded to by the company would be the initial positive balance after paying for the supplies and the costs of R&D.   If you run a company, you are forever in a situation of debt (lines of credit to buy supplies) and future profit (sales of your product). These have to be balanced. What was also said is that after the initial start up costs are

[fubwar]

When your market is the globe that is enough to justify a big valuation