GnuBio Inc, a pioneer in the ‘sample in, answer out’ desktop DNA-sequencing market, has initiated formation of a clinical advisory panel (CAP), to be composed of experts and luminaries in the field of clinical diagnostics.
A privately held company based in Cambridge, Mass, GnuBio is focused on the field of scalable DNA-sequencing technology for the diagnostic and applied research markets. According to the company, the new advisory panel will initially focus on four areas of product development: oncology, cardiovascular disease, pharmacogenomics, and women’s health. The panel is expected to bolster the company’s efforts in standardized assay content development.
GnuBio’s system offers a number of attributes that make it especially suited to clinical applications, including desktop ease of use, sensitivity, long reads, and high accuracy. Traditional complex targets such as HLA (for transplantation compatibility), and CYP2D6 in ADME, can easily be interrogated and interpreted. The company believes such attributes give the system technical advantages over competitive sequencing technologies.
“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,” said John Boyce, cofounder, president, and CEO of GnuBio.
The GnuBio system is the size of a desktop computer and provides a fully integrated sequencing solution, without the need for extensive sample preparation or expensive robotics. In use, the researcher or clinician 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.
“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 ‘hotspot’ panels will streamline patient diagnosis and treatment, thus significantly improving patient care and reducing healthcare costs,” said Boyce.
The company believes that the small footprint and pricetag of the system—$50,000—will ensure rapid adoption of the GnuBio solution.
For the research use only (RUO) market, additional genes and hotspots can easily be added to an existing standard panel at little cost, since the GnuBio 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.
To build the new advisory panel, “We will be selecting renowned experts as well as regulatory experts, to help guide the company with clinical content and with IVD design guidelines,” said Boyce. GnuBIO encourages clinical diagnostics experts and luminaries to contact the company for CAP consideration.
For further information, visit GnuBio.