GnuBIO has initiated the formation of its Clinical Advisory Panel, composed of luminaries and experts in clinical diagnostics, bolstering its efforts in standardized assay content development
Cambridge, Massachusetts – (February 4, 2014) GnuBIO, Inc. (GnuBIO), www.gnubio.com the pioneer in the “Sample In, Answer Out” Desktop DNA sequencing market, announced today that it is initiating the formation of its Clinical Advisory Panel (CAP), composed of experts and luminaries in the field of clinical diagnostics. The four initial areas of focus for the CAP will be within the fields of oncology, cardiovascular disease, pharmacogenomics, and women’s health.
With its ease of use, GnuBIO, www.gnubio.com, has technical advantages over all competitive sequencing technologies by combining sensitivity, long reads, and high accuracy. These combined attributes make the technology ideal for the clinic. Traditional complex targets such as HLA (for transplantation compatibility), and CYP2D6 in ADME, can easily be interrogated and interpreted.
“Leveraging these attributes, we identified the pain points and unmet needs of the clinic, resulting in a host of assays and targets that are currently unavailable to clinicians,” stated John Boyce, President, CEO, & Co-Founder of GnuBIO.
“Coupling the “Sample In, Answer Out” ease of use of the GnuBIO system with validated off the shelf cartridges of medically actionable gene panels and targeted “Hot Spot” panels, will streamline patient diagnosis and treatment, thus significantly improving patient care and reducing healthcare costs,” stated Boyce. “We will be selecting renowned experts as well as regulatory experts, to help guide the company with clinical content and with IVD design guidelines,” Boyce continued.
For the Research Use Only (RUO) market, additional genes and hotspots can easily be added to an existing standard panel at very little cost, since the GnuBIO, www.gnubio.com system utilizes emulsion based sequencing methodology whereby each emulsion acts as its own test tube. This obviates the need for complicated panel redesign and new multiplexing conditions each time new content is added.
GnuBIO encourages clinical diagnostics experts and luminaries to contact the company for CAP consideration.
Unlike other sequencing instruments or “workflows” that require many days of sample preparation, or require large upfront expensive robotics, the GnuBIO system is the size of desktop computer and provides a fully-integrated solution. The researcher or clinician simply injects the patient genomic DNA into a cartridge with no need for target enrichment or library preparation, loads the cartridge into the instrument, hits the “Go” button, and in 3.5 hours receives the analyzed sequence of the gene panel including variant calls and quality scores. Both the small footprint of the system, as well as the price of $50,000 USD all in – no additional equipment or large robotics to purchase – will ensure rapid adoption of the GnuBIO solution.
Susie Truong Harborth
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