03 jul: Europa luk: Hæderlige stigninger over alt
04 jul: USA/aktier: Fabriksordrer og bilsalget løftede markedet
03-07-2012 21:09:00

UPDATE: FDA Approves OraSure's Over-The-Counter Home HIV Test

Relateret indhold

--FDA approves first HIV test to be sold in retail stores

--Test will be available in October

--Home test appears to be not as accurate as tests by health professionals

(Adds company comments on test availability, pricing, in the third and fourth paragraphs.)

By Jennifer Corbett Dooren

WASHINGTON--The Food and Drug Administration Tuesday approved a home HIV test that will be sold in retail stores so people wouldn't have to go to a health facility to learn if they have the virus.

The test, made by OraSure Technologies Inc. (OSUR), has been available to health-care professionals. The test, called the OraQuick In-Home HIV test, uses a mouth swab to collect saliva. The swab is then inserted into a test tube where results are made available within a 20-to-40 minute time frame.

Company officials said the test will be available in October and sold at more than 30,000 retailers such as Wal-Mart Stores Inc. (WMT) and large grocery and drug-store chains including CVS Caremark Corp. (CVS), Rite Aid Corp. (RAD) and Walgreen Co. (WAG). The test will also be sold online.

OraSure said a price hasn't been established but it will be slightly higher than the $17.50 currently paid by health-care professionals, to fund additional labeling costs and a customer-support center.

The FDA said a positive result needs to be confirmed with a follow-up test in a health-care facility. The agency also said negative readings don't necessarily mean people aren't infected with HIV because the test might not be able to pick up infections within three months before testing.

Still, the agency said the test has the potential to identify large numbers of previously undetected HIV infections, especially if used by people unlikely to use standard screening methods.

About 1.2 million people in the U.S. are infected with HIV, and about 50,000 infections are diagnosed each year, a level that has been stable for a decade. Federal health officials have estimated that 20% of people with HIV don't realize they are infected and risk spreading the virus, which causes AIDS.

"Knowing your status is an important factor in the effort to prevent the spread of HIV," said Dr. Karen Midthun, director of FDA's Center for Biologics Evaluation and Research. "The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate."

However, there is one concern about the home test: Clinical testing has showed it doesn't appear to be as accurate as tests conducted by health professionals.

One measure of the test's accuracy in the home setting showed it had a sensitivity rate of 92%. The FDA said this means there would be one false negative test result for every 12 tests taken in HIV-infected individuals.

The FDA said one false positive result would be expected out of every 5,000 test results taken by uninfected individuals.

Write to Jennifer Corbett Dooren at jennifer.corbett@dowjones.com.

(END) Dow Jones Newswires

July 03, 2012 15:09 ET (19:09 GMT)

Copyright (c) 2012 Dow Jones & Company, Inc.

Opret kommentar

Relateret debat

  • 1 uge
  • 1 måned
  • 1 År
Ingen indlæg

Fondsbørsmeddelelser

Coloplast/CEO: Har underskrevet ny VA-kontrakt på trods af fejl

16-08-2017 14:33:48
En fejl i administrationen af kontrakten med det amerikanske veteranministerium, U.S Department of Veterans Affairs, har betydet, at det danske medicoselskab Coloplast vurderer, at det skal tilbagebetale 90 mio. kr. til ministeriet.Selskabets oplyste om engangsbeløbet i regnskabet for tredje kvartal af det forskudte regnskabsår 2016/2017, der blev fremlagt onsdag ved middagstid, og her fremgik det..

Aktier/middag: Mærsk og Carlsberg deles om top og bund i grønt C20

16-08-2017 11:33:01
Med plusser til størstedelen af de danske eliteaktier ligger C20 Cap-indekset onsdag middag i positivt terræn, og med til at trække op er Mærsk-aktierne efter koncernens regnskab. Omvendt bliver Carlsberg straffet for sit.Samlet går C20 Cap-indekset frem med 0,3 pct. til 1170,82, og dermed følger det danske eliteindeks trenden i resten af Europa, hvor de fleste aktieindeks ligeledes noterer stigni..

Aktier/tendens: Regnskaber i centrum for udvikling i C20 Cap

16-08-2017 08:36:09
Der er ikke meget påvirkning eller inspiration at hente fra udlandet for de danske investorer onsdag, og dagens udvikling i C20 Cap-indekset vil sandsynligvis blive bestemt af dagens regnskaber fra nogle af indekset tunge selskaber med A.P. Møller-Mærsk i spidsen.C20 Cap-indekset lukkede tirsdag med et fald på 0,1 pct. til 1167,07.De amerikanske aktier lukkede tirsdag med små udsving tæt på nulpun..

Mest læste nyheder

  • 24 timer
  • 48 timer
  • 1 uge
1
Vestas/Sydbank: Sætter tungt aftryk på konkurrencepræget marked - NY
2
NNIT/CEO: Vi stopper ikke op og håber på Novo Nordisk
3
Spar Nord opjusterer og ændrer udbyttepolitik
4
Vestas bekræfter ordre på 424 MW i Mexico
5
Danske rederier har nået bunden - citat

Relaterede aktiekurser

Rite Aid Corporation 2,28 -1,3% Fald i aktiekurs
Wal-Mart Stores Inc 80,98 0,3% Stigning i aktiekurs
CVS Health Corporation 79,25 0,2% Stigning i aktiekurs
OraSure Technologies Inc 20,29 -1,2% Fald i aktiekurs

Køb- og salgsanbefalinger

  • Trend
  • Pengemaskinen

Copyright Euroinvestor A/S 2017  Disclaimer Privatlivspolitik
Aktieinformation leveres af Interactive Data.
Data er forsinket 15-20 minutter iht. de enkelte børsers regler om videredistribution.
 
17. august 2017 05:52:04
(UTC+01:00) Brussels, Copenhagen, Madrid, Paris
Version: LiveBranchBuild_20170808.1 - EUROWEB2 - 2017-08-17 05:52:04 - 2017-08-17 05:52:04 - 1 - Website: OKAY