The Beverly, Massachusetts-based company’s MiQLab system delivers excellent sensitivity, specificity, and breadth of detection, and can test for 27 pathogens and return results in about one hour versus one-to-three days at a lab.
In a letter to shareholders, Regan said LexaGene had scaled up manufacturing in late-2020 and early-2021.
“We spent considerable efforts ensuring consistency in microfluidic operations across MiQLab systems. Now that we have reached our expectations for consistency, we are again ramping up manufacturing,” said Regan.
“As of today, we have built 20 MiQLab systems and have enough parts in-house or on order to build an additional 70 systems. Through a partnership with an FDA-compliant contract manufacturer, we have the capacity to rapidly scale the manufacturing of our consumables to meet demand.”
Regan said LexaGene is investing resources in supporting the veterinary diagnostics market, where it is validating new assays that will help “veterinarians better detect disease-causing pathogens and antimicrobial resistance markers to make evidence-based treatment decisions.”
The molecular diagnostics company, which develops fully automated rapid pathogen detection systems, will be hosting a seminar for a select group of veterinarians on April 14. A key opinion leader, who is using the firm’s technology, will present on collected data.
“The open-access market continues to be a focus for us, specifically contract drug manufacturing organizations (CDMOs), pharmaceutical companies, and cosmetic manufacturers,” said Regan.
“We are aggressively developing new tests for these industries that will further increase the value of our product as a quality control tool to help keep vaccines, biologics, and consumer products safe.”
Over the last three months, LexaGene has made substantial progress on FDA requirements for software and hardware testing which are pre-requisites to complete the COVID-19 EUA application.
“On the biology side, our preliminary limit-of-detection (LoD) tests for SARS-CoV-2 suggest the MiQLab sensitivity is competitive with the best point-of-care molecular systems on the market today,” said Regan.
“We plan to continue the additional work needed for the COVID-19 EUA application as soon as we complete the validation work necessary for the MiQLab’s software, signal processing algorithm, and microfluidic scripts.”
As is standard practice, until the US Food and Drug Aadministration grants LexaGene’s instrument EUA for COVID-19 testing, all work using LexaGene instruments is classified as research use only.
Contact the author Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive
Story by ProactiveInvestors
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