imjake
2 años hace
Well, isn't that a kick in the teeth! They have a product that, according to management, is better than anything out there, and cheaper too, but can't break into the market?? WTF! Not even Chapter 11, but 7. Now they'll take the product and start a new company and screw us all.
marcg
3 años hace
LexaGene Starts the Year with Additional MiQLab Sales
BEVERLY, Mass. USA – January 3, 2022 – LexaGene Holdings, Inc., (TSX-V: LXG; OTCQB: LXXGF) (the “Company”), a molecular diagnostics company that has commercialized an instrument for automated multiplex PCR testing, is pleased to announce three additional purchase orders for MiQLab™ Systems from veterinary clinics in Michigan, Minnesota, and New York.
Julie Griggs, LexaGene’s Global Director of Sales, stated, “My team is diligently engaged with numerous veterinary practices, both private and corporate. Many of the veterinarians we have spoken to share our excitement over the value of in-clinic PCR testing and the capabilities that the MiQLab System can provide to their practices. It is gratifying to welcome 2022 with a strong start and continue our momentum as we work on closing additional sales.”
Dr. Jack Regan, LexaGene’s Founder and CEO said, “I’m pleased that we are making headway in the veterinary diagnostics marketplace. By acquiring MiQLab Systems, veterinary practices are setting themselves apart from their competition, as this technology allows them to elevate the standard of care they provide to companion animals. We look forward to educating veterinary practices in the coming year, regarding the importance of in-clinic PCR testing, and aim to revolutionize veterinary diagnostics through the sale of MiQLab Systems. No longer should veterinary practices empirically diagnosis our companion animals or send samples off to labs only to wait days or weeks for results when they can have a treatment plan in a fraction of the time.”
LexaGene is participating in the upcoming Veterinary Meeting and Expo (VMX) in Orlando, Florida, where more than 6,500 veterinarians, veterinary technicians, and practice managers will gather mid-January. On Sunday, January 16th, Dr. Jack Regan will be a presenter at the conference. Participants can attend his presentation entitled, “In-Clinic PCR Testing for Pathogen and Resistance Detection,” at 9:00 a.m. in the VMX Learning Theater.
marcg
3 años hace
GREAT NEWS. They're going for the whole enchilada!
LexaGene Intends to Pursue Full Panel Pathogen Testing through the FDA
November 24, 2021 16:00 ET | Source: LexaGene Holdings Inc
...
BEVERLY, Mass., Nov. 24, 2021 (GLOBE NEWSWIRE) -- LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG) (“LexaGene” or the “Company”), a molecular diagnostics company that has commercialized an instrument for automated multiplex PCR testing, today announced it intends to pursue both 510k clearance and CLIA-waiver from the FDA to utilize the full potential of the MiQLab System™ for syndromic testing at the point of care.
Syndromic testing allows medical providers to simultaneously test patient specimens for multiple pathogens that produce overlapping signs and symptoms. MiQLab’s broad multiplexing provides this capability and also allows for testing other clinically important markers such as antimicrobial resistance genes. Antimicrobial resistance is widely considered to be the next global pandemic.1 Scientists estimate that drug resistant pathogens will kill ~10 million people per year by the year 2050.2
Dr. Jack Regan, LexaGene’s Founder and CEO stated, “One of the hardest challenges in medicine is to rapidly identify, at the point-of-care, the exact cause of complex and difficult to treat infections.3 We’ve developed the MiQLab to tackle this challenging problem. It is capable of processing sample types that traditionally inhibit PCR (e.g., urine and fecal samples) and screens for up to 27 targets including drug resistance markers so it can be used in the fight against superbugs. We believe the MiQLab will be on the forefront of helping clinicians accurately diagnose and treat their patients at the point of care so that a pandemic caused by antimicrobial resistant pathogens can be avoided. Similarly, syndromic panels like respiratory or gastrointestinal panels will enable clinicians to more rapidly and conveniently diagnose infectious diseases, enabling earlier treatment and prevention.”
The Company has been steadily working to meet FDA requirements for human clinical diagnostics. The progress we have made during the pursuit of EUA for COVID-19 testing has brought the Company closer toward meeting the more extensive requirements of the traditional premarket review pathway, which will be required for the Company to offer broad panel pathogen testing at the point of care. The FDA recently provided industry-wide guidance4 and based on this guidance and direct communications with the agency, the Company has decided it will no longer pursue an EUA application for COVID-19, but instead pursue 510k and CLIA-waiver for broad-panel pathogen testing, thereby allowing the Company to focus on providing the MiQLab technology for its intended use of syndromic testing at the point of care.
LexaGene’s MiQLab system is unique in that it is a flow-through PCR system. To LexaGene’s knowledge, the FDA has never received an application for a flow-through PCR system for use in human clinical diagnostics. Until the FDA grants LexaGene’s system authorization for human clinical diagnostics, all work using LexaGene instruments is classified as Research Use Only.
The Company continues to sell its technology into veterinary hospitals, bio-pharmaceutical manufacturers, and other open-access markets.
Boredoftv
3 años hace
Looking good!!
8:17a ET 11/2/2021 - Globe Newswire
LexaGene Receives 2021 BioTech Breakthrough Award
Mentioned: LXXGF
LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG) ("LexaGene" or the "Company"), a molecular diagnostics company that has commercialized an instrument for automated multiplex PCR testing for veterinary diagnostics, today announced it was named the 2021 BioTech Breakthrough Molecular Diagnostics Solution of the Year.
The BioTech Breakthrough Award selection committee performs a comprehensive evaluation of life sciences and biotechnogly tools, services, and companies identifying innovative and standout technology that will improve the world. Award winners rise above their competitors and are considered stand out technology in a crowded market across many sectors. The program is open to all individuals or companies involved in producing publicly available products and services. Featured winners cross multiple categories, including but are not limited to biopharma, therapeutics, genomics, immunology, bioagriculture, and bioindustrial. Judges represented a mix of technology, business, academic, and marketing expertise within the industry.
Dr. Jack Regan, CEO and Founder of LexaGene stated, "We continue to make great strides in building our brand as we break through a crowded biotechnology market with our MiQLab(TM) System. This award is specifically focused on the concept of innovation, performance, functionality, value, and impact. I'm very proud of the strides we've made as we build a product that is like no other in the market. Our one-of-kind technology quickly and accurately diagnoses infections and detects drug resistance allowing for effective early treatment."
He continued, "In just five short years, we've gone from a concept on paper to a commercialized product. Recognition like the one received from BioTech Breakthrough and the recently announced opportunity to be a Best in Show Spotlight company at the upcoming 47 Petcare Innovation Summit, reinforces to me, our Board, and our employees, that we have a cutting edge technology that will impact multiple markets."