NEW YORK (GenomeWeb) – GenMark Diagnostics announced today that it has submitted 510(k) applications to the US Food and Drug Administration for its ePlex sample-to-answer instrument and respiratory pathogen panel.
ePlex combines digital microfluidics with the firm's eSensor electrochemical detection technology to enable precise fluid management and accurate results, and the respiratory panel detects clinically relevant viral and bacterial targets from nasopharyngeal samples, the firm said.
GenMark said that its ePlex instrument integrates and automates all components of the testing process, from nucleic acid extraction and amplification, through detection, interpretation, and reporting, and that the instrument enables bi-directional integration to laboratory information systems and the ability to provide customer support via remote access.
GenMark President and CEO Hany Massarany said in a statement that "feedback from European customers and US clinical trial sites reinforces" the instrument's unique value proposition, adding that the firm continues to focus on growing the ePlex's global commercial reach and expanding its menu.
The instrument will offer molecular diagnostic panels on a scalable sample-to-answer system, designed to enable syndromic infectious disease testing in hospital and reference laboratories, the firm added.
"We expect our blood culture ID family of panels, including the Gram-positive, Gram-negative, and fungal panels, to be available in Europe during the first quarter of 2017,” Massarany said.
GenMark said it has optimized the instrument's workflow and efficiency so that it requires around two minutes of hands-on time.
The ePlex instrument and respiratory pathogen panel were launched in Europe in June 2016.
In a research note today, Cowen analyst Doug Schenkel said FDA approval for the ePlex instrument and respiratory panel could come as soon as in three months, and likely no later than in six months, "setting up [GenMark] for an early- to mid-Q2 US launch."
Schenkel said that despite the news of the FDA submissions, the firm would not change its global forecast of 192 ePlex placements in 2017, or its blood culture consumables revenue forecast of $200,000 also for 2017.