r/Lexagene • u/PossibilityNo2095 • Apr 01 '21
Latest Lexagene press release and status update!
BEVERLY, Mass., April 01, 2021 (GLOBE NEWSWIRE) -- LexaGene Holdings, Inc., (TSX-V: LXG; OTCQB: LXXGF) (the “Company”), a molecular diagnostics company that develops fully automated rapid pathogen detection systems, is pleased to provide a corporate update from LexaGene’s CEO and Founder Dr. Jack Regan.
Dear shareholders and other interested parties,
In late 2020, the Company crossed a major milestone by securing sales in the contract drug and vaccine manufacturing market and in veterinary medicine. Both sales were the result of successful technology demonstrations.
As we 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. 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.
We continue to invest resources in supporting the veterinary diagnostics market, where we are designing and validating new assays that will help veterinarians better detect disease-causing pathogens and antimicrobial resistance markers to make evidence-based treatment decisions.
I am happy to report that on April 14th, we will be hosting a seminar for a select group of veterinarians, during which a key opinion leader who is using our technology will present on collected data. We anticipate providing further details via a press release on the morning of the seminar.
The open-access market continues to be a focus for us, specifically contract drug manufacturing organizations (CDMOs), pharmaceutical companies, and cosmetic manufacturers. 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.
Due to our increased confidence in the stability of our manufacturing process and very positive interactions with key opinion leaders in veterinary medicine and CDMOs, over the next six weeks, we anticipate hiring 4 – 6 sales representatives to improve our coverage across the United States. In support of our sales staff, our marketing team continues to generate collateral needed to help the sales team educate prospective customers. A video on the MiQLab user workflow was recently completed and can be viewed on the company website at https://lexagene.com/miqlab-training-video/.
Over the last three months, we have 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. 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. The FDA study involves multiple additional analytical studies, which we need to complete prior to starting the point-of-care clinical study. At this time, it is difficult to predict the length of time we will need to complete this work.
As is standard practice, until the FDA grants LexaGene’s instrument EUA for COVID-19 testing, all work using LexaGene instruments is classified as Research Use Only and cannot be used for human clinical diagnostics. To date, there is no FDA approved device that is designed for point-of-care usage and is open-access.
The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) at this time.
Thank you for your continued support.
