The Role of Molecular Diagnostics in Antibiotics Stewardships Programs

Edel O'Regan:
Hello, this is Edel O'Regan, Vice President of Production for Cambridge Innovation Institute. Today I bring you a podcast on the Molecular Diagnostics for Infectious Disease Conference, which is part of the 11th annual Next Generation Diagnostic Summit. This summit convenes more than 1000 international diagnostics professionals for valuable networking and comprehensive programming, spanning from clinical diagnostics to business strategy. The infectious disease track, now in its ninth year will take place at the Grand Hyatt Washington hotel, in Washington, DC. From August 16 through 17.

I'm here today with Dr. Elena Grigorenko, who is VP of research and development at Diatherix. Dr. Grigorenko will give a presentation at the event on the role of molecular diagnostics in antibiotic stewardship programs. Elena, thank you for being a speaker at our upcoming molecular diagnostics for infectious disease conference in DC. What are you looking forward to hearing about at the conference?

Elena Grigorenko:
Well, I think CHI has a great program this year, and I am specifically interesting to hear about practical experience of utilization of next generation sequencing in routine diagnostic practice for pathogen detection. I do believe that existing molecular diagnostics such as multiplex PCR tests will be replaced in the future by viral or bacterial targeted sequencing. However this is not ready yet, because the complex sample prep work load, long turn around time, lack of clear regulatory guidelines for validation of such complexity tests presents a significant hurdle for adoption of next gen sequencing in a clinical microbiological laboratory. I'm also looking forward to hear opinions of early adopters of these technologies for clinical application, and to learn how we can incorporate it into a clinical diagnostic setting.

Edel O'Regan:
That makes perfect sense, Elena. What do you see as some of the biggest technology advances in your field at the moment, and perhaps some of the challenges that are being faced?

Elena Grigorenko:
That's a difficult question to answer. The whole molecular diagnostic field is shifting in two main directions in my opinion, and you can clearly see an integration of the multiple steps of laboratory processes into the cartridge based turn key disposable system, and the second is testing for multitude of clinically relevant pathogens. So several cartridge based diagnostic tests already gained credibility in hospital labs and overall market space, and the pathogen menu for testing is really expanding. But I think the main challenge right now for device manufacturers and the service providers like Diaterics is not really related to technology advancement embodied in diagnostic tests, but rather related to reimbursement in the constantly changing healthcare environment.

So the rapid explosion of very good multiplex molecular diagnostic tests on the market created a confusion among the payers. And the current situation in reimbursement for molecular diagnostics, in general, in my opinion is a typical example that would happen if science outpaced reimbursement. The whole molecular diagnostic industry right now at the pivotal moment, and it's really imperative not to be a passive watcher, but rather an active participant. To be engaged with discussions with government and the private payers.

Edel O'Regan:
Elena, can you tell us a little bit about your own work, and what you will review in your presentation next month.

Elena Grigorenko:
Sure, we started working with ThermoFisher Scientific on the development of an antibiotic resistance panel almost two and a half years ago. And in preparation for my talk, and looking back now, I realized how many challenges we had overcome during development process of this panel and how much more we will face if we expand this panel beyond Beta Lactam plasmid based resistances. So in my presentation I'm going to highlight the challenges related to the development of the genetic drug resistance panel, its validation in a CAP certified laboratory, because what we developed is not FDA approved test. The challenges we're also facing in adoption and utilization of such genetic drug resistant panels in a clinical setting.

Edel O'Regan:
Thank you, Elena. We certainly looking forward to hearing your talk at the summit next month.

Elena Grigorenko:
Thank you very much.

Edel O'Regan:
That was a podcast about the upcoming Molecular Diagnostics for Infectious Disease Conference in DC, August 15 through 18 at the Grand Hyatt Washington hotel.