Bringing the power of GenMark ePlex® syndromic panels together with Roche
The ePlex® Respiratory Pathogen Panel 2 (RP2) identifies the most common viral and bacterial organisms associated with upper respiratory infection, including SARS-CoV-2, the virus that causes COVID-19.
The ePlex® RP2 Panel identifies and detects more than 20 of the most common respiratory viruses and bacteria causing respiratory illness in about 90 minutes, allowing doctors to make informed patient care decisions faster. Rapid diagnosis is important for people who are more likely to become seriously ill from complications or require hospitalization, such as young children, adults 65 and older, pregnant women and those with compromised immune systems.
The emergence of SARS-CoV-2 in late 2019 sparked a global pandemic, with cases and deaths continuing to rise. The high mortality associated with COVID-19 and the need for rapid isolation to reduce spread and prompt initiation of treatment makes it more critical than ever to quickly identify the cause of respiratory infections.
During the annual respiratory illness season when infections tend to peak (October through March in the northern hemisphere and April through September in the southern hemisphere),1 influenza is often the first virus people think of. Globally, the WHO estimates there are 3 to 5 million cases of severe illness due to seasonal influenza, and 290,000 to 650,000 deaths annually.2 Other viruses, such as Respiratory Syncytial Virus (RSV) and metapneumovirus, are also more prevalent at certain times of the year, while others, like adenovirus and rhinovirus, are common year-round. No seasonality for SARS-CoV-2 has been identified yet and infections are expected to remain elevated during respiratory illness season.
We believe the syndromic approach to diagnosis of infectious diseases can result in:
By detecting the most common pathogens that cause disease together on a single rapid test, with a single patient sample, you can prescribe the right therapeutic within hours – rather than days, when compared with conventional testing algorithms.
Comprehensive testing with a syndromic respiratory panel ensures that clinicians get the information they need to make an informed decision. This can mean that a patient avoids unnecessary antibiotic treatment, and the possible adverse side effects that may be caused by them. Reducing unnecessary use of antimicrobials also aids in antimicrobial stewardship.
|ePlex® Respiratory Panel 2 targets|
|Adenovirus||Influenza A H1-2009|
||Influenza A H3
|Coronavirus OC43||Parainfluenza 2|
|Human Bocavirus||Respiratory Syncytial Virus A|
|Human Metapneumovirus||Respiratory Syncytial Virus B|
|Human Rhinovirus/Enterovirus||Bordetella pertussis|
|Influenza A H1||Mycoplasma pneumoniae|
ePlex® RP2 Panel available in the US under Emergency Use Authorization (EUA) includes Chlamydia pneumoniae, and does not include MERS-CoV, Human Bocavirus, Bordetella pertussis or Legionella pneumophila.
ePlex® Panels, System and Software are developed and manufactured by GenMark Diagnostics, Inc. and distributed by Roche.
GenMark IFUs can be accessed through the customer resource center.
This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency use Authorization (EUA) for use by authorized laboratories. This test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2 and multiple respiratory viral and bacterial organisms and this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.