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20/20 GeneSystems launches first accelerator facility for innovative clinical lab tests

20/20 GeneSystems, Inc.

The shared CLIA lab aims to help diagnostics start-ups, including Australian-based Minomic, more rapidly enter the U.S. market

30 Sept 2021
Ellen Simms
Product and Reviews Editor

Industry news

20/20 GeneSystems, Inc., has announced the launch of its Clinical Lab Innovation Axcellerator (CLIAx), believed to be the first shared CLIA laboratory facility geared to helping diagnostic test innovators worldwide substantially reduce the time and cost of launching their tests in the U.S.

“Establishing and maintaining a compliant CLIA lab can be costly and daunting for young companies, especially those seeking to enter the American market from overseas,” 20/20 President and CEO, Jonathan Cohen said. “From leasing facilities to hiring qualified laboratory professionals, purchasing equipment, and running daily operations, it can be a hefty burden. These hurdles can limit or delay our nation’s access to some of the most creative and out-of-the-box testing solutions from around the world demonstrated during the pandemic to be in great demand. Our unique CLIA Axcellerator removes or lowers many of the barriers in the path of these innovators.”

CLIAx offers nearly 3,000 square feet of ready-to-use communal clinical laboratory space and testing equipment, including a full PCR/molecular assay suite, next-generation sequencing (NGS), immunoassay, and clinical chemistry capabilities. Importantly, 20/20’s marketing and sales teams will help promote the new tests introduced by CLIAx’s clients to the market segments in which 20/20 is currently active.

Earlier this month the company signed an agreement with Australian-based Minomic International Ltd., a diagnostics firm that is gearing up to introduce MiCheck® Prostate, a blood test that uses proprietary algorithms and biomarkers to estimate the risk of aggressive prostate cancer. “Our company is so excited to be working with the CLIAx team. Their clinical lab accelerator is a unique concept that allows us to tap into the expertise in laboratory testing. It is just what Minomic requires - a ‘soft landing’ site to enter the U.S. market so we can focus on the key activity of test rollout instead of the necessary minutiae of setting up and running a lab service,” said Dr. Brad Walsh, CEO of Minomic International Ltd.

CLIAx was officially designated by the Maryland Department of Commerce as a “Soft Landing” program for overseas companies seeking to enter the U.S. market. “Maryland is 'open' for international companies looking to expand, and the new Clinical Laboratory Innovation Axcellerator will provide the perfect soft landing for those seeking to explore the U.S. market," said Maryland Commerce Secretary Kelly M. Schulz. "We applaud 20/20 GeneSystems for taking the lead with this initiative and we hope to see similar spaces launch throughout the state."

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Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.Clinical MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Next Generation SequencingNext-generation sequencing (NGS), also known as whole-genome sequencing, high-throughput sequencing and massive parallel sequencing, produces and analyses thousands to millions of nucleotide sequences at once. Sequencing systems operate via varying technologies depending on the manufacturer, including sequencing by synthesis, ligation, pyrosequencing, ion semiconductor and single-molecule real-time sequencing. For NGS, library preparation is paramount to successful sequencing. In this section, explore a range of library preparation kits, from targeted, amplicon-based or hybridization-based kits including epigenomic, transcriptomic and genomic workflows to fragmentation kits. Find the best next-generation sequencing products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Clinical ChemistryClinical chemistry involves the analysis of bodily fluids, like blood and urine, to diagnose and monitor diseases. Tests in clinical chemistry provide critical information for patient care and treatment decisions. Explore clinical chemistry tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.Clinical StudyProspective biomedical or behavioral research studies on human subjects, following tests in animals, that are designed to answer specific questions about novel vaccines, drugs, treatments, dietary supplements, devices or new ways of using known interventions, generating safety and efficacy data.

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20/20 GeneSystems launches first accelerator facility for innovative clinical lab tests