When medical diagnostics firm LexaGene needed to rapidly produce parts for its “game-changing” analyzer, it turned to Exothermic Molding. The custom molder went from concept to delivery in three days, shipping out parts the minute the paint dried.
System OverviewThe MiQLab genetic analyzer, developed by LexaGene, features multiplexed target detection capability (27 concurrent targets), approximately 60-minute processing time, and simplified user interface implementation.
The system architecture enables operation without specialized technical personnel, positioning it as a significant advancement in SARS-CoV-2 diagnostics, according to LexaGene.
For rapid prototype fabrication, LexaGene collaborated with Exothermic Molding Inc. The specification included:
Given their extensive experience in medical diagnostic equipment fabrication, production constraints were within Exothermic's manufacturing capabilities. However, the accelerated timeline presented significant logistical challenges.
"The assembled prototypes were slated for shipment to a photo shoot and to a show with extremely tight deadlines," said Exothermic Production Manager Jorge Perez in a prepared statement. "Exothermic's Assistant Production Manager James Patnaude shepherded this project through in record time. We had to take the finishing operations from concept to delivery in just three days. We literally had to ship the job out as soon as the paint dried. James had the courier service standing by and the product was delivered from our New Jersey plant to LexaGene's CEO at his home on a Saturday," said Perez.
Exothermic has proposed utilizing reaction injection molding technology for production units. The company implements Proxima resin, a high-performance polymer characterized by exceptional durability-to-weight ratios. This material was developed by Dr. Robert Grubbs, a 2005 Nobel laureate in chemistry for his work in metathesis in organic chemistry.
LexaGene projects market penetration across multiple sectors including healthcare facilities, maritime vessels, and food processing facilities. Initial deployment is scheduled through an Early Access Program targeting veterinary and open-access market opinion leaders by Q4. Implementation delays were attributed to COVID-19-related supply chain disruptions affecting the system's 230 distinct components.
LexaGene is pursuing FDA Emergency Use Authorization (EUA) for SARS-CoV-2 detection in near-patient settings. The EUA protocol requires comprehensive validation of:
Additional EUA requirements have been implemented in response to recent market quality control issues. EUA validation studies are scheduled to commence late December. Pre-EUA approval, the MiQLab system cannot be utilized for clinical diagnostic applications.