Benzinga | Jun 14, 2021 08:07AM EDT

HTG Says Completes Product Design Lock For Planned Transcriptome Panel, Announces Signing Of 3 Early Adopter Program Collaboration Agreements

HTG Molecular Diagnostics, Inc. (NASDAQ:HTGM) (HTG), a life science company whose mission is to advance precision medicine, today announced it has completed product design lock for the HTG Transcriptome Panel and announced three Early Adopter Program (EAP) collaborators. HTG continues to progress in its development of a planned transcriptome panel using the HTG EdgeSeq technology. This panel, expected to be called the HTG Transcriptome Panel, will measure approximately 20,000 mRNA targets, with a planned research use only commercial launch in the third quarter of 2021.



"I am excited to report that we have fully implemented all planned requirements for our HTG Transcriptome Panel and achieved product design lock," said Dr. Marian Navratil, Senior Vice President of Research and Development. "Our development team has spent the past four months characterizing and optimizing the panel's design in an effort to ensure its peak performance and robustness. Product design lock is one of the most critical milestones in the product development lifecycle, allowing the project to advance into design verification. During the design verification phase, we will independently confirm that all performance requirements, including precision and accuracy, have been implemented before we proceed to commercialization. We believe this second-generation HTG chemistry will serve as the backbone for our future RNA gene expression products."

Achieving design lock also allows HTG to formally begin its previously announced Early Adopter Program with several collaborators with whom HTG has been planning studies with for the past several months. The EAP allows this select group of customers access to the initial transcriptome panel for use in their laboratories or through services performed by HTG prior to the planned commercial launch of the panel in the third quarter. The EAP will also provide collaborators with priority access to product purchases and the ability to contract with HTG to execute laboratory service projects on their behalf prior to commercial launch.

"Successful completion of this key milestone has allowed us to begin the finalization of EAP agreements, study details and logistics, and we believe it will allow us to begin study execution in the next few weeks," said Byron Lawson, Senior Vice President and Chief Commercial Officer. "Demand for access to our Early Adopter Program has exceeded our expectations, with discussions ongoing with nearly 40 potential EAP collaborators in academia and pharma. Several top prestigious cancer centers and research institutions throughout the US and Europe have expressed interest in our planned HTG Transcriptome Panel and participation in the EAP. In the past week, we signed EAP Collaboration Agreements with three top institutions in the US, including the University of Texas MD Anderson Cancer Center, Duke University Medical Center and Saint John's Cancer Institute, each of which is at the leading edge in delivering precision medicine with a focus on novel technologies like our HTG EdgeSeq technology.

"In addition to those expected to participate in the EAP, many new and existing customers have requested pricing quotes for kit purchases or lab service projects leveraging the HTG Transcriptome Panel, and commercialization plans continue to progress as we move toward a planned global commercial launch in the third quarter of 2021," Mr. Lawson continued.