GenMark Diagnostics Inc. 01.13.16
GenMark Diagnostics Inc., which makes automated, multiplex molecular diagnostic testing systems, has reported preliminary fourth quarter 2015 results. The company also has completed the transfer to manufacturing of its ePlex system and initiated analytical studies in support of European launch.
Preliminary fourth quarter 2015 revenue was $13.2 million, an increase of 35 percent over the prior year period. Accordingly, the Company expects full year 2015 revenue to be $39.4 million, an increase of 29 percent versus 2014. During the quarter, 17 additional XT-8 analyzers were placed in end-user laboratories, resulting in a total installed base of 633 analyzers within the U.S. market.
“We drove a strong finish to the year in spite of a slower than expected start to the flu season,” said President and CEO Hany Massarany.
In addition, the company commenced analytical studies of its ePlex Respiratory Pathogen Panel.
“Following the positive results generated from initial internal and external studies and successful transfer to manufacturing, we initiated analytical studies in support of our upcoming European launch,” added Massarany.
The company still expects a first quarter 2016 launch of ePlex in Europe and 510(k) submission to the U.S. Food and Drug Administration in the second quarter of 2016.
Preliminary fourth quarter 2015 revenue was $13.2 million, an increase of 35 percent over the prior year period. Accordingly, the Company expects full year 2015 revenue to be $39.4 million, an increase of 29 percent versus 2014. During the quarter, 17 additional XT-8 analyzers were placed in end-user laboratories, resulting in a total installed base of 633 analyzers within the U.S. market.
“We drove a strong finish to the year in spite of a slower than expected start to the flu season,” said President and CEO Hany Massarany.
In addition, the company commenced analytical studies of its ePlex Respiratory Pathogen Panel.
“Following the positive results generated from initial internal and external studies and successful transfer to manufacturing, we initiated analytical studies in support of our upcoming European launch,” added Massarany.
The company still expects a first quarter 2016 launch of ePlex in Europe and 510(k) submission to the U.S. Food and Drug Administration in the second quarter of 2016.