Skip to main content
Premium Trial:

Request an Annual Quote

GenMark Diagnostics Q1 Revenues Rise 13 Percent

NEW YORK (GenomeWeb) – GenMark Diagnostics reported after the close of the market on Tuesday that its first quarter revenues rose 13 percent, driven by strong sales of its XT-8 molecular diagnostics system.

For the three months ended March 31, the molecular diagnostics firm reported revenues of $12.5 million, up from $11.1 million a year ago, and matching the consensus Wall Street estimate.

"Customer experience with ePlex has confirmed its superior ease of use and workflow efficiency, compared with other systems on the market," GenMark President and CEO Hany Massarany said in a statement. "We designed ePlex to seamlessly integrate the entire diagnostic process from test order entry to reporting patient results."

He also noted that GenMark's customers are "very positive" about the firm's efforts to expand the ePlex menu, including its three-panel approach to sepsis testing.

"We recently achieved CE mark for the Blood Culture ID Fungal Pathogen panel and expect the gram positive and gram negative pathogen panels to follow suit this quarter," he said. "Additionally, our regulatory and clinical affairs teams have been working very closely with the [US Food and Drug Administration] on our 510(k) submissions for the ePlex instrument and RP panel. We have closed out all the questions raised by the agency during its review process and expect FDA clearance soon."

GenMark said that it now has more than 70 ePlex customer agreements in place for a total of more than 100 analyzers. The firm highlighted its recent CE marking for the ePlex Blood Culture Identification Fungal Pathogen panel.

"As we expected, 2017 is shaping up to be a pivotal year for our company," Massarany said on a conference call with analysts following the release of the financial results. "Building on our strong Q1 performance, we expect to successfully launch ePlex in the USA and drive its continued adoption and business success in the European and US market, while of course continuing to support our XT8 business."

He noted that ePlex contributed to the firm's Q1 top line, but "most of our revenues came from our installed base of XT8 analyzers in the USA."

The company's net loss widened slightly to $13.9 million from $13.0 million a year ago. Its loss per share stayed flat at $.30, missing analysts' average estimate for a loss of $.28 per share.

GenMark's R&D costs dropped 11 percent to $11.0 million from $12.3 million in Q1 2016, and its SG&A costs rose 23 percent to $8.7million from $7.1 million.

GenMark ended the quarter with $13.2 million in cash and cash equivalents, and $11.0 million in marketable securities.

For 2017, the company reiterated its previous guidance for revenues of between $65 million and $70 million. Analysts expect revenues of $67 million for the year.

Massarany noted on the conference call that "our three-panel approach to sepsis testing…will provide the broadest pathogen inclusivity and drug resistance markets of any multiplex molecular solution on the market today."

He also added that ramping up ePlex placement and revenues in Europe and driving its successful launch in the US will remain significant areas of focus and priority for 2017.

GenMark's shares were down more than 2 percent to $12.77 in Wednesday morning trading on the Nasdaq.


The Scan

Drug Response Variants May Be Distinct in Somatic, Germline Samples

Based on variants from across 21 drug response genes, researchers in The Pharmacogenomics Journal suspect that tumor-only DNA sequences may miss drug response clues found in the germline.

Breast Cancer Risk Gene Candidates Found by Multi-Ancestry Low-Frequency Variant Analysis

Researchers narrowed in on new and known risk gene candidates with variant profiles for almost 83,500 individuals with breast cancer and 59,199 unaffected controls in Genome Medicine.

Health-Related Quality of Life Gets Boost After Microbiome-Based Treatment for Recurrent C. Diff

A secondary analysis of Phase 3 clinical trial data in JAMA Network Open suggests an investigational oral microbiome-based drug may lead to enhanced quality of life measures.

Study Follows Consequences of Early Confirmatory Trials for Accelerated Approval Indications

Time to traditional approval or withdrawal was shorter when confirmatory trials started prior to accelerated approval, though overall regulatory outcomes remained similar, a JAMA study finds.