Vision

Imagine a world where a single trip to the doctor results in a complete diagnosis of a patient's ailments. It would require testing for multiple possible causes, with immediate follow-up on any results, leading to immediate prescription of therapy, or clear and direct referrals. MBio has the vision that this diagnosis can be performed in any clinic, anywhere in the world, with powerful yet simple to use diagnostic technology.

Mission

MBio's mission is to deliver the technology that enables rapid, accurate diagnosis for multiple indications with a single drop of blood, right in a clinic or doctor's office. We are focusing first on infectious disease, and developing a full suite of products for HIV diagnosis and management, including screening for the spectrum of co-infections, a count of CD4 T-cell abundance, and the measurement of viral load. All in a package that is affordable and effective in any clinic, whether in New York or Nairobi. The technology can be adapted to many diagnostic areas, and MBio is seeking partners to develop tests across the spectrum of human disease.

Company History

MBio Diagnostics, Inc. was originally established as a division of Precision Photonics Corporation (PPC, www.precisionphotonics.com) in Boulder, Colorado. Founded by optical measurement scientists from Nobel-prize winning laboratories at the University of Colorado, MBio's management brings technology commercialization skills from over a decade of commercial success at PPC. To complement the instrumentation expertise of the company's founders, MBio has assembled a team of diagnostic industry veterans and has established strong relationships with a world-class group of clinical collaborators. The company also has an active Silicon Valley based investor group (Incubic, LLC) that has provided seed financing and ongoing business guidance. MBio Diagnostics, Inc. spun out of Precision Photonics in late 2009 and is now a privately held company based in Boulder.

The company has successfully built prototypes of the instrument, developed key infectious disease assays, and delivered them to collaborators in locations around the world. MBio has validated the technology with over 20,000 test cartridges, and nearly 1,000 patient samples. MBio is moving quickly towards regulatory approvals for initial applications, and is now opening the platform for researchers, developers, and partners.

Business Strategy

The MBio technology is broadly applicable to a wide variety of applications that can or should be run in a clinic, a doctor's office, or ultimately in the home. Our strategy is to develop certain indications independently, while licensing or partnering to develop the full spectrum of tests that our technology can deliver. MBio is actively seeking partners for HIV and hepatitis, as well as other non-infectious disease applications, and non-human diagnostic applications.

With the simplicity of the MBio's core LightDeckTM technology, we can quickly develop unique diagnostic tools. We focus on specific vertical market applications and have built deep clinical datasets demonstrating assay multiplexing, quantitation, sensitivity, and data connectivity in a simple, affordable package. MBio has chosen to focus first on unmet needs within the infectious disease testing market. MBio has established strong and active working relationships with key opinion leaders in the global health diagnostics field.

MBio management has adopted an unconventional corporate financing and growth strategy, requiring no formal equity investment to date. The company has used federal grant mechanisms, internal funding through sister company Precision Photonics, and bridge financing from the core investors to develop and validate the technology. In addition, the company has successfully sought in-kind support through funded collaborations.

We at MBio recognize that intellectual property is a key value component of our business, and we have therefore made a significant investment in core intellectual property protection. MBio holds exclusive license to a portfolio of over 30 issued United States and international patents protecting its multiplexed planar waveguide technology. MBio also has multiple applications in prosecution and active trade secret protection. Further recognizing the value of IP in product positioning and value, the company has invested heavily in product clearance due diligence.

MBio's regulatory strategy is to invest in regulatory infrastructure to build FDA-compliant operations, significantly reducing risk for potential commercial collaborators and licensees. In doing so, MBio is also poised to initiate clinical trials and regulatory filings as appropriate.

At the genesis of MBio as a concept, management laid out a plan to develop inexpensive, diagnostically powerful instrumentation as a unified system for critical global health applications, with an emphasis on AIDS: (1) diagnosing not just HIV infection but its common co-infections, enabling optimization of therapy, (2) measuring CD4 cell count and viral load at the point of care, enabling the best standards of care for those on HIV therapy no matter where in the world, and (3) differential diagnosis of fevers of unknown etiology, with a panel approach that would have value throughout the world. With guidance from an exceptional clinical team, we recognized that the standard of care for the developed and developing worlds would converge, and a powerful yet affordable system such as we proposed would be highly valued in clinical practice.