ePlex® RP: Delivering Rapid Results to Clinicians

GenMark Customer Spotlight

Professor Astrid Vabret

Professor of Virology and the Head of the Virology Department at the University Hospital of Caen, France. Prof Vabret is a leading expert in France for respiratory virus diagnosis and advocates for routine testing of rapid respiratory viral panels.

What led you to pursue implementation of the ePlex Respiratory Pathogen (RP) panel?

In the laboratory of medical virology we have been doing respiratory virus detection for about 10 years. Early on we started with traditional multiplex RT-PCR with electrophoresis, but over the past 10 years we have focused on advancing our techniques with multiplex real-time qRT-PCR. However, we faced challenges and problems regarding the delay of the results to the clinicians. The need to report respiratory diagnostics quickly has increased due to the clinical impact of respiratory infections. As a result, we wanted to implement ePlex RP in our lab to deliver a very rapid response to clinicians. So far we have been able to deliver a very precise and quick response to questions concerning acute respiratory infections. Implementation of ePlex provided this for us and has been a significant improvement for respiratory diagnosis in our lab.

Why did you choose to implement the ePlex RP panel for all adult patients rather than just a specific population such as Intensive Care Unit (ICU) patients?

I believe multiplex respiratory pathogen panels are a routine test and we should use such a test for all hospitalized patients; adults, children and infants. The limitation is often cost, but we are working with hospital administration to build evidence showing it is not possible for us to continue to use classical qRT-PCR with a delay in response of 24 hours. We need the benefits of a very rapid test from sample-to-result. At current, the only limitation of the prescription of the ePlex RP panel is the cost, but I expect with clinical impact data we can prove we can use it for all patients.

What impacts have you observed from a clinical perspective as a result of implementing the ePlex RP panel?

Currently in France we do not have medical economic studies for the introduction of the multiplex sample to result molecular tests. We have several studies on-going in the adult ICU and we expect to have final results in 2018. The preliminary results illustrate more rapid de-escalation of antibiotics. This observation is very important in terms of the ICU as antibiotics are costly, but also because this is critical in the fight against antibiotic resistance. In addition, clinicians are very happy when they receive a clear result which can enhance patient care and improve patient satisfaction for the family. With ongoing studies we should also have results regarding the duration of hospitalization. Lastly, while we cannot measure the impact of rapid multiplex sample-to-report respiratory testing on the various decisions inside the hospital, we expect clinicians will be able to change their prescription of antibiotics. After we measure the clinical impact throughout the hospital this type of testing will become more broadly utilized with all hospitalized patients.

The need to report respiratory diagnostics

quickly has increased due to the clinical impact of

respiratory infections.

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Professor Astrid Vabret

GenMark Diagnostics Europe GmbHChollerstrasse 46300 ZugSwitzerland

info@genmarkdx.com

GenMark Diagnostics, Inc.5964 La Place CourtCarlsbad, CA 92008USA

As you know, flu virus circulates during eight or nine weeks per year so during 10 months we don’t have flu. RSV circulates during five months with a bit in December. As a result, the most prevalent virus we detect is the rhinovirus. We have the RSV and the flu during the annual outbreaks, but from a prevalence perspective we detect a lot rhinoviruses, coronaviruses, parainfluenza viruses and also adenoviruses. We have samples from infants and from adults. From infants, we detect a lot rhinovirus and RSV, and also flu, but in children too. In adults, we detect a lot of rhinoviruses and coronaviruses, and parainfluenza viruses. Based on prevalence, when you have a severe acute respiratory infection you cannot predict the viruses you will detect except if you are in the peak of the flu outbreak for example.

So I think we have to be able to detect any respiratory viruses in the context of severe acute respiratory infection in hospitalized patients. I think we have to do the entire panel or nothing in this context. It’s the same thing in the community of elderly. When there are several cases of the outbreak in the community, we use the total respiratory panel because it’s important to know which virus is implicated in this outbreak.

What initiatives or what studies do you have planned for next flu season or next year in regards to the ePlex RP panel?

As I mentioned, we are in process of conducting medical and health economic studies to ultimately utilize this data to drive reimbursement of these tests based on medical and health economic benefit. For the next respiratory season we are participating in a larger France study in an effort to convince the state to reimburse for routine use of multiplex respiratory panel testing.

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For more information on ePlex® and the RP Panel, please visit www.genmarkdx.com

How has the move to the ePlex RP panel impacted lab efficiency?

Yes, the ePlex RP test is so easy that the resulting improvement in lab efficiency has allowed us to spend more time to develop and implement other techniques, such as sequencing. With improved lab efficiency we can also study the epidemiology of respiratory viruses and implement databases to assist in diagnosis and treatment. Of course, the first step is detection of the respiratory pathogen, but that is easy and requires really no technician time. As a result, you can use your technicians to do so much more to improve the utility of information coming out of the lab.

You also provide testing services to other hospitals. Has that improved or changed with implementation of ePlex?

Yes, in my lab in you cannot request just a flu detection. We run the entire panel or nothing. We do not offer a prescription for just flu or RSV and as result we only offer the ePlex RP panel.

Do you have any data on the percent of positive samples for outside labs that are not flu or RSV? If you don’t have data, can you talk about these observations?

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