MiQLab System

The 1^st generation MiQLab System provided quality data at the point-of-need where samples were collected. This System quickly detected multiple pathogens and contaminants in ~2 hours.

Proceeds from recapitalizing the Company in 2023 is providing the development team with the resources necessary to develop a 2^nd generation MiQLab System that is ideally suited for biopharmaceutical manufacturing.

MiQLab System
Overview Video

MiQLab is an automated, open-access molecular diagnostic system for pathogen detection, allowing users to test for multiple pathogens onsite, returning results in ~2 hours.

Technology Overview

A brief overview of how the technology will change from the 1^st generation to the 2^nd generation MiQLab System to give LexaGene the best opportunity to succeed in this very attractive market is provided below.

Detection Range

The 1^st generation MiQLab System was able to detect up to 24 targets using qPCR. The 2^nd generation MiQLab System is being designed to detect > 95% of all possible bacterial contaminants.

Sensitive Detection

Biopharma contamination testing requires samples to be tested to 10 colony forming units / milliliter (CFU/mL). Our team at LexaGene Life Sciences’ is making appropriate modifications and enhancements to allow for improved sensitivity.

Easy to Use

Hands-on time <1 min with integrated sample preparation and easy to interpret results.

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How it Works

Fully automated PCR system that provides a digital readout.

System Configuration

Scan and insert PCR reagents and sample preparation buffers, which are stable on-system for six weeks

Hands on time < 1 minute

Load sample into single-use disposable cartridge
Scan cartridge barcode and insert into the system

Automated Run-time

Contaminants are concentrated on a filter and lysed
Nucleic acids (DNA and RNA) are purified and combined with PCR reagents
Semi-quantitative PCR occurs and these data are analyzed
A digital readout is delivered into a laboratory information management system (LIMS)

2nd Generation MiQLab System Test Specifications

LexaGene’s ^2nd generation system will offer 4 broad tests to meet customer requirements.*

Total Bacteria Test (Will detect ~95% of all known Gram+ & Gram– bacteria)
Total Fungi Test (Will detect ~90% of all known fungi)
Total Mycoplasma Test (Will detects ~120 strains of Mycoplasma and related species)
Common Virus Test (Will come in two varieties)
4 viruses documented to have caused contamination in CHO cells
5 viruses documented to have caused contamination in human and primate cells

* The development of these tests will be staggered such that LexaGene can get to market as quickly as possible with the most desirable test.

Specifications and Target Profile

Based Industry feedback, the target profile for MiQLab has been refined to account for broad test panels at the required sensitivity.

Size (WxLxH)	Small footprint and easily shipped (11″x 15″x 15″)
Weight	30 lbs
Total Targets Screened	Total Bacteria Test (~95% coverage), Total Fungi Test (~90% coverage), Total Mycoplasma Test ( ~ 120 coverage), Most Common Viruses Test
Mode of Detection	Semi-quantitative PCR (qPCR)
Designed to handle CHO cells at 25 million/mL	Yes
Volume of sample processed	1,000 – 10,000 uL
Time-to-Result	~2 hrs
Hands-on-Time	< 1 min (can be operated by non-technical personnel)
Sensitivity	<10 CFU/mL
21 CFR Part 11 compliant	Yes
Internal process control integrated in cartridge	Yes
External positive and negative controls provided	Yes

“I’ve been moving everything to in-line or near-line for the past 3 years. I’m not there yet. I have a roadmap that will take me to 2027, and the one piece that is missing is bioburden. For 4.0, we need to play there. That is the number one bottleneck that we have to achieving real-time release.
– Head, Process Analytical Technology, Leading BioPharmaceutical Manufacturer

LexaGene’s key differentiation is near-line and eventually at-line

	Compendial culture-based tests	Standard PCR	2nd generation MiQLab System
Turnaround time	5-28 days	1-2 days*	~2 hrs
Hands-on time	Moderate	Moderate	1 min
Personnel experience	Moderate	Significant	Minimal
Use Case	Offline, near-line	Offline, near-line	Near-line Ultimately at-line
*3 hrs processing time

What is PCR?

Learn about the gold-standard of testing used by the MiQLab system.