An Interview with HTG Molecular Diagnostics | Advance Healthcare Network
By Advance Staff
Vol. 20 • Issue 11 • Page 50
Editor's note: We're pleased to introduce this new series, Industry Views, to provide an inside look at technological changes and developments in the clinical laboratory.
ADVANCE talks with TJ Johnson, CEO of HTG Molecular Diagnostics, about the future of the clinical laboratory.
What are exciting developments in the laboratory industry?
Johnson: The vision and practice of personalized healthcare is truly starting to gain momentum. A vast amount of discoveries have been made in recent years, and those discoveries are being translated into new prognostic, diagnostic and predictive tests. The rate of new learning and new molecular tests is accelerating and generating numerous new opportunities for the laboratory industry.
What are obstacles facing the industry and field of laboratory medicine?
Johnson: With all the exciting developments and accelerated changes in molecular diagnostics come several obstacles that lab personnel have to overcome. The laboratory industry still struggles with labor shortages, complexities of new technologies and methods, and the general need to do more with less.
There is a substantial amount of ambiguity around reimbursement changes and questions surrounding how these new molecular tests will be paid for. Uncertainty makes it very difficult to plan for anything, so labs must be as nimble as possible for the foreseeable future.
How is your company poised to meet the needs of laboratories?
Johnson: HTG Molecular is targeting our solutions to assist diagnostic labs in expanding their current molecular testing capabilities. Our qNPA technology has inherently less complexity and fits more easily into a lab's workflow than other gene expression methods while enabling high multiplexing of specimens with a focus on formalin fixed paraffin embedded (FFPE) tissue. We also require less starting material due to our extraction free protocol.
Here is how our technology works: The lab can use virtually any specimen type, whether it is cultured cells, fresh/frozen tissue or FFPE. In the event the lab is using FFPE, they can simply scrape the entire section off the slide into a vial, or they may choose to microdissect just the tumor area of the section; either way is acceptable. Microdissection enhances the specificity of the results.
The qNPA reaction takes place in the sample prep vial. The lab adds our proprietary Lysis Buffer with probes, which opens the cells to allow the probes to bind to the target RNA. Any non-targeted RNA, DNA or other material that is not bound to the probes is then removed with our S1 Nuclease step.
At this point, the reaction is halted with a stop solution, which destroys the S1 nuclease and the bound target RNA. The solution is then neutralized, and we are left with probes representative of the native RNA. The rest of the process is simple detection and imaging on the array plate and our SUPERCAPELLA imaging system. The data from the imager is delivered to the customer for normalization and analysis.
Quite simply, we are very focused on providing a solution that reduces the labor intensity required with traditional molecular testing by reducing the need for specialized labor, fitting into the current lab workflows and utilizing much smaller specimen quantities. Our qNPA technology enables the lab to take advantage of all of these benefits, while maintaining highly accurate results.
HTG offers a robust multiplexed gene expression platform for FFPE with no extraction, labeling or amplification. The future of multiplexed gene expression in FFPE is in products such as HTG's qNPA technology.