Lexagene Holdings Inc LXXGQ

POC

[Chopper1BigDog]

LexaGene Launches EUA Tests for Microfluidic PCR Device in Point-of-Care Facilities
Published: Jan 18, 2021
By Gail Dutton

LexaGene has begun a series of studies aimed to bring its MiQLab from research-only use to point-of-care use to detect the SARS-CoV-2 virus. Emergency use authorization (EUA) would add a rapid test with the accuracy of polymerase chain reaction (PCR). It is designed for use by the 193,000 CLIA-certified labs in hospitals and clinics throughout the U.S.
“The key for point of care systems is ease of use, but PCR is complicated by nature,” LexaGene CEO Jack Regan, Ph.D., pointed out. “It is vendors’ responsibilities to make it easy regardless of the training of the operator.”
The MiQLab does that. MiQLab is a PCR-based system coupled with microfluidics. Because it is open access, it can be quickly configured to detect emerging variants of the virus.
Users need only to “transfer a collected nasal swab sample into a MiQLab cassette, which is then inserted into the system, and then use the touch screen monitor to initiate sample processing. It takes less than a minute,” he told BioSpace. Results are available in a little over an hour – notably faster than the days often required for reference labs to return PCR results.
One of the key features is built-in sample preparation, which purifies the genetic material from the sample. Many of the rapid diagnostic kits designed for COVID-19 skip sample prep, he said, “but it improves the quality of the data. We’re not trying to compete based on speed only.  Antigen-based tests have a high degree of false negatives.” LexaGene offers an alternative.
Obtaining FDA Emergency Use Authorization for a point-of-care setting is complicated and time-consuming, especially for a novel technology like the MiQLab System. To help speed FDA evaluation, Regan said, “We’re using the CDC’s SARS-CoV-2 diagnostic test, automated on our system. That test is validated for use in reference labs. We want to ensure the FDA is comfortable with our automated system, and this removes one question mark.”

[ragb7002]

We know all that "stuff" When is anticipated approval? No one says and further more where are the sales to other disciplines? No announcements. What's the reason,we would ALL LIKE TO KNOW. THANK YOU.