Frost & Sullivan Applauds GenePOC's Commitment to Advancing Molecular Diagnostics through Technological Leadership and Patient-centric Innovation

GenePOC's multifactorial strategy, as it innovates toward global leadership, expands testing menus tailored to specific geographies

LONDON, Oct. 24, 2017 /PRNewswire/ -- Based on its recent analysis of the molecular diagnostics (MDx) market for infectious diseases, Frost & Sullivan recognises GenePOC™ with the 2017 European Frost & Sullivan Award for New Product Innovation. GenePOC™'s groundbreaking infectious disease MDx system, the revogene™, combines a smart design with centripetal forces and cutting-edge micro technologies to deliver simple, rapid, and tailored microbial testing at the point-of-care (POC). Its smart and multipronged approach to product design and commercialisation addresses the relevant concerns of cost efficiency and safety in today's clinical practice and public health.

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GenePOC™'s disruptive, CE-marked and FDA cleared revogene™ instrument endows it with an early mover advantage in the in the MDx space. It is currently used to detect hospital-acquired infections (HAIs) and, critical infectious diseases, which require immediate diagnosis and prompt treatment.

"GenePOC™ employs cutting-edge micro technologies to provide a high-quality, user-friendly, and scalable POC MDx solution," said Frost & Sullivan Program Manager, Unmesh Lal. "It employs its fully-automated, portable standalone instrument, the revogene™, and single-use microfluidic cartridges, or PIEs, in its proprietary fluorescence-based quantitative polymerase chain reaction (qPCR) platform to deliver an accurate diagnosis."

The revogene™ is the size of a laptop and holds up to eight PIEs, allowing independent testing of multiple clinical samples and tests per run. Additionally, it utilises spinning disc technology, driving the liquid sample flow in the PIEs, eliminating the need for valves and multiple piston pumps that increase instrument and cartridge costs. The revogene™ system currently supports:

• Affordable, accessible, quality solutions
• Simple, streamlined patient-centric workflows
• Real-time diagnostics
• Reliable and accurate results that strengthen decentralized POC diagnostics

Meanwhile, the PIE is a single-use cartridge, comprising only three pieces of plastic, making it simpler and less expensive to manufacture than competing consumables, which require at least 23 pieces of plastic. Its cartridge size is much smaller than any other commercial product, resulting in lower handling cost and decreased wastage. The cartridge's unique design incorporates three reaction wells, each a self-contained DNA-based amplification assay that can detect up to four genetic targets. As such, each PIE can detect 12 targets per sample, allowing GenePOC™ to introduce the concept of mini-panels to POC infectious disease MDx.

"The company initiated commercial activities for the revogene™, and its two CE-marked in vitro diagnostics tests, in all Western European countries in early February 2017, and with the 1^st FDA cleared test in May 2017, and aims to expand to Central and Eastern Europe," noted Lal. "GenePOC™ is considering partnerships in Canada, as it expects approval by Health Canada in the coming months. It is also alert to opportunities for distribution partnerships in emerging and developing economies, and tailoring testing according to each region's need."

Furthermore, GenePOC™ will apply for a Clinical Laboratory Improvement Amendments (CLIA) waiver from its third diagnostic assay and onwards. If approved, the test will represent a huge competitive advantage and shape the POC infectious disease MDx landscape.

Each year, Frost & Sullivan presents this award to the company that develops an innovative element in a product by leverage leading-edge technologies. The award recognises the value-added features/benefits of the product and the increased ROI it gives customers, which, in turn, raises customer acquisition and overall market penetration potential.

Frost & Sullivan Best Practices awards recognise companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research to identify best practices in the industry.

About GenePOC™

GenePOC is a company that specializes in the development of diagnostic devices which enable the prevention and detection of infectious diseases.
The company aims to become the market leader in the rapid microbial testing at the point of care (POC). GenePOC is a member of the Debiopharm Group.
GenePOC's revogene instrument is available in the US and EU markets with a rapidly expanding test menu.

Further information: www.genepoc-diagnostics.com

About Frost & Sullivan

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Estefany Ariza
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