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GenMark Sees Jump in Preliminary Q3 Revenues, Nabs Respiratory Panel FDA Emergency Use Authorization

NEW YORK ─ GenMark Diagnostics announced after the close of the market on Thursday preliminary third quarter revenues of approximately $42.6 million, which would represent a 104 percent spike compared to $20.9 million reported in Q3 2019.

Separately, the Carlsbad, California-based molecular diagnostics firm announced that it has received Emergency Use Authorization from the US Food and Drug Administration for its ePlex Respiratory Pathogen Panel 2 (RP2).

GenMark said that for the three months ended Sept. 30, it had net placements of 70 ePlex analyzers and finished the quarter with a global installed base of more than 720 ePlex analyzers, an increase of 47 percent compared to Q3 2019.

The average annuity per analyzer in Q3 is expected to be approximately $193,000, up 82 percent year over year.

GenMark said it exited the quarter with ePlex Respiratory Pathogen Panel 2 (RP2) revenues representing approximately 63 percent of all ePlex consumables revenues, driven by a growing number of customer conversions from ePlex SARS-CoV-2 to RP2 ahead of the upcoming flu season.

The company said it expects revenues from its ePlex products to be approximately $38 million, up 187 percent compared to Q3 2019.

Scott Mendel, GenMark's president and CEO, said in a statement that the company continued "to see strong demand for both ePlex systems and consumables," and "a significant portion" of its customers adopted sample-to-answer syndromic testing for the first time.

"In addition to our commercial successes in the quarter, our manufacturing expansion effort remains on track to meet our capacity goal of 150,000 to 175,000 tests per month by the end of 2020 and 200,000 per month by the end of first quarter of 2021," Mendel added.

The company said its newly authorized ePlex RP2 test provides results in less than two hours for more than 20 viruses and bacteria that cause common and often serious respiratory infections, including SARS-CoV-2, influenza A and B, respiratory syncytial virus (RSV), and rhinovirus.

The multiplex, syndromic RP2 panel provides rapid results for infections with similar symptoms such as fever, cough, and body aches and includes a new, simplified workflow that makes it easier for labs to run the test, GenMark said.

"While we can’t predict what cold and flu season is going to look like this year, we know that we have to arm healthcare providers with the necessary tools to quickly and accurately diagnose the cause of infections in seriously ill patients, so syndromic testing is going to be critical," Mendel said in a statement.

The firm said in September that its ePlex RP2 Panel received the CE mark, enabling its use for clinical diagnosis in Europe and other regions that accept such designation.  

The development of the ePlex RP2 Panel has been funded to the tune of $749,000 by the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA).

In March, GenMark received FDA EUA for its ePlex SARS-CoV-2 Test.