FDA Authorizes First At-Home Test To Detect Flu And COVID-19

RTTNews | 878 dagar sedan
FDA Authorizes First At-Home Test To Detect Flu And COVID-19

(RTTNews) - The U.S. Food and Drug Administration has approved the first over-the-counter or OTC at-home diagnostic test to detect both influenza and COVID-19 viruses. The decision is part of its efforts to increase the availability of home diagnostic tests.

In a statement, the agency said it has issued an emergency use authorization or EUA for Lucira Health, Inc.'s Lucira COVID-19 & Flu Home Test that can differentiate and detect influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19.

The single-use at-home test kit provides results from self-collected nasal swab samples in around 30 minutes.

The test is for individuals with signs and symptoms consistent with a respiratory tract infection, including COVID-19. They can purchase the kits without a prescription and can perform completely at-home. Nasal swab samples can be self-collected by individuals ages 14 years or older or collected by an adult for individuals 2 years of age or older.

They then need to swirl the sample swab in a vial that is placed in the test unit. In 30 minutes or less, the test unit will display the results that show whether a person is positive or negative for each of the following: Influenza A, Influenza B and COVID-19.

Individuals are asked to report all results obtained to their healthcare provider for public health reporting and to receive appropriate medical care.

The agency noted that the Lucira COVID-19 & Flu Home Test correctly identified 99.3% of negative and 90.1% of positive Influenza A samples in individuals with symptoms. It also identified 100% of negative and 88.3% of positive COVID-19 samples and 99.9% of negative Influenza B samples.

Meanwhile, there are currently not enough cases of Influenza B circulating to include in a clinical study. The validation has confirmed that the test can identify the virus in contrived specimens.

The EUA requires Lucira to continue to collect samples to study the test's ability to detect Influenza B in real-world settings.

The FDA said it will continue to use its authorities to increase the number of appropriately accurate and easy to use at-home tests available to the public, especially tests that detect these highly contagious respiratory viruses.

Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said, "Today's authorization of the first OTC test that can detect Influenza A and B, along with SARS-CoV-2, is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home. ... we are eager to continue advancing greater access to at-home infectious disease testing to best support public health needs."

For More Such Health News, visit rttnews.com

read more
Deutsche Bank Shares Up On Highest Q2 Profit Since 2007; Maintains FY25 Guidance

Deutsche Bank Shares Up On Highest Q2 Profit Since 2007; Maintains FY25 Guidance

Shares of Deutsche Bank AG were gaining around 7 percent in the morning trading in Germany and around 6 percent in the pre-market activity on the NYSE, after the banking major reported Thursday a net profit in its second quarter, compared to prior year's loss, mainly on the non-recurrence of a litigation provision, and higher revenues.
RTTNews | 11 minuter sedan
German Consumer Sentiment To Weaken In August: GfK

German Consumer Sentiment To Weaken In August: GfK

Consumer confidence in Germany is set to deteriorate in August as households preferred to save rather than spend due to the escalating uncertainty, survey data from the market research group GfK revealed on Thursday. The Consumer Climate indicator dropped unexpectedly to -21.5 points in August from -20.3 points in July. The score was forecast to improve to -19.4.
RTTNews | 12 minuter sedan
CAC Flat In Cautious Trade As Investors Focus On Earnings

CAC Flat In Cautious Trade As Investors Focus On Earnings

French stocks are turning in a mixed performance on Thursday with investors making cautious moves despite growing optimism the U.S. and EU will arrive at a trade agreement soon. Investors are digesting corporate earnings updates, and await the European Central Bank's monetary policy announcement due later in the day.
RTTNews | 17 minuter sedan
DAX Up Nearly 1% As Stocks Extend Gains On Trade Deal Optimism

DAX Up Nearly 1% As Stocks Extend Gains On Trade Deal Optimism

German stocks are notably higher on Thursday, extending gains from the previous session, thanks to rising optimism about trade following reports the US and EU are heading towards a deal that will see implementation of 15% tariffs on select European imports, as well as scrapping of some duties.
RTTNews | 41 minuter sedan
European Shares Extend Gains Before ECB Rate Decision

European Shares Extend Gains Before ECB Rate Decision

European shares traded higher on Thursday to hit a six-week high as investors digested a slew of earnings and awaited the European Central Bank's interest-rate decision later in the day.
RTTNews | 1h 28minuter sedan
Asian Shares Follow Wall Street Higher On Trade Deal Optimism

Asian Shares Follow Wall Street Higher On Trade Deal Optimism

Asian stocks advanced on Thursday as companies like Alphabet and SK Hynix posted encouraging earnings and media reports suggested that the EU and U.S. are closing in on a trade deal that would impose 15 percent tariffs on European imports.
RTTNews | 2h 1minuter sedan
Antipodean Currencies Rise As Trade Optimism Prevails

Antipodean Currencies Rise As Trade Optimism Prevails

The antipodean currencies such as the Australia and the New Zealand dollars strengthened against their major counterparts in the European session on Thursday, after reports emerged that the U.S. and EU are edging closer to a trade deal.
RTTNews | 2h 42minuter sedan