OSUR Approval Green-Light's CEMI's OTC Program? - Analyst Blog
05 Luglio 2012 - 8:06PM
Zacks
OSUR Approval Green-Light's CEMI's OTC
Program?
Brian Marckx, CFA
OraSure's Rapid HIV FDA
Approved For OTC Market
On Tuesday (7/3) the FDA approved OraSure's
(OSUR) OraQuick over-the-counter rapid
HIV test. The test, which uses an oral swab (saliva) as the
sample and is basically identical to the test sold to the clinical
market, is the first HIV test to be approved for home use.
While the approval was not a total surprise given that in May an
FDA advisory panel (Blood Products Advisory Committee) voted
unanimously in favor of approving the test, there were some
lingering doubts given concerns about the risk of false positives
from the test. OraSure's shares jumped on the news on Tuesday
and are up over 15% from the closing price on Monday.
Chembio (CEMI) has noted in the
recent past that they might pursue FDA approval of their Sure Check
(lateral flow, using blood sample) rapid HIV 1/2 test for the OTC
market. In September 2011 the FDA provided guidance that
Chembio will need to perform additional studies in order to submit
for an Investigational Device Exemption (IDE). FDA clarified
the regulatory pathway and Chembio has since completed the
instructional manual for home-use testing. But before
spending any substantial time and financial resources on an OTC
program, including running clinical trials, Chembio was waiting for
the FDA's decision on OSUR's OTC test. Tuesday's news now
opens the door for Chembio to pursue OTC approval of its Sure Check
rapid HIV test, which is already FDA approved for the clinical
market. As we've noted previously, as eventual FDA approval
of a Sure Check OTC test is still uncertain (although chances are
likely now more favorable with FDA approval of OraQuick) and not a
near-term event, we do not yet include any contribution from it in
our model.
We cover Chembio with an Outperform rating and $10.40 price target.
CHEMBIO DIAGNOS (CEMI): Free Stock Analysis Report
ORASURE TECH (OSUR): Free Stock Analysis Report
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