) has won the U.S. Food and Drug Administration (FDA) clearance
for its Alere Determine HIV 1/2 Ag/Ab Combo test used to identify
HIV-1 p24 antigen and antibodies to HIV-1/HIV-2. The company's
new offering is the first and only FDA-approved test in the
market. This rapid point-of-care test is superior to the second
and third generation antibody-only tests and can detect HIV more
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HIV, a fatal health issue, is affecting the U.S. as well as other
regions. According to the Centers of Disease Control and
Prevention (CDC), about 18% of the 1.4 million Americans with HIV
are undiagnosed. The center also stated that approximately 47,500
new individuals have been infected with the virus in 2010.
Mass.-based Alere aims to be the leader in rapid 'near-patient'
or point-of-care testing (POCT) or diagnostics. The FDA approval
of Alere's latest point-of-care test is a significant step toward
the eradication of HIV from the U.S., as it helps to diagnose the
disease at an early stage and can assist in breaking the
infection cycle. The FDA has approved the product to be sold as a
CLIA (Clinical Laboratory Improvement Amendments) moderately
complex medical device.
Recently, the company received a FDA approval for its Alere
MobileLink. The new connected device technology allows quick data
delivery from patient's home settings to their healthcare
provider. The Alere MobileLink is already CE-Marked and will be
rolled out in Europe and the U.S. toward the back end of this
ALR has a Zacks Rank #1 (Strong Buy). On Jul 31, the company
reported adjusted earnings per share of 59 cents for the second
quarter of 2013. The results were up 40.5% on a year-over-year
basis, and beat the Zacks Consensus Estimate by a significant
margin of 19 cents. Net revenue grew 9.1% to $764.0 million,
exceeding the Zacks Consensus Estimate of $722 million.
Other medical stocks such as
) are worth considering. All these stocks carry a Zacks Rank #1