), a leader in multiplex molecular tests systems, recently
announced the 510(k) clearance by the U.S. Food and Drug
Administration (FDA) for its eSensor Respiratory Virus Panel for
use in its XT-8 system. The company filed the application for the
test with the FDA in December, 2011.
Per management, the 510(k) clearance of the eSensor Respiratory
Virus Panel test underlines the company's competency in providing
differentiated electronic detection technology as required for
consumer needs and specifications. The approval underlines the
company's focus to offer products geared to deliver stellar
GenMark's newest test is designed to identify and differentiate
14 clinically important viruses from patients with influenza-like
illness. As far as specificity, sensitivity and detection is
concerned, the eSensor Respiratory Virus Panel test is more
efficient vis-à-vis other multiplex respiratory viral panels, as it
can distinguish Rhinovirus from Enterovirus and also separately
The eSensor Respiratory Virus Panel test is expected to improve
laboratory efficiency and thereby enhance standards of patient
care. The test also enables efficient time and workload management
for laboratory staff.
The international market for molecular diagnostics has been
estimated at around $4.5 billion with an annual growth rate of
roughly 15%. Management at GenMark believes that its present
portfolio is capable of catering to a market size of $0.9 billion
in 2012. The expansion of its tests menu for XT-8 systems and
successful commercialization of this newest test might help the
company to gain market share.
Thus far, net loss from operations and GenMark's failure to
achieve profitable growth remains an overhang. The operating
expenses are expected to increase in the coming years as the
company attempts to expand its customer base and increase research
and development expenditure to upgrade its technology. Increasing
) is also a matter of concern.
However, the rigorous sales and marketing efforts coupled with
production efficiency is expected to yield positive results for
GenMark. The favorable market conditions and extended customer base
are also expected to boost the company's top-line. The stock
currently retains a Zacks #3 Rank, which implies a short-term Hold
GENMARK DIAGNST (GNMK): Free Stock Analysis
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