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What We Do

Darwin Biosciences specializes in developing saliva-based diagnostics for the early detection of infectious diseases.

Affiliated Institution: University of Colorado Boulder

Have we formed a company? Yes

Funding: Other

Our Company and the Problem We Are Trying To Solve

Darwin Biosciences is a developer of diagnostic tests that promise to shift detection to an earlier stage of infection, allowing for more impactful interventions into the chain of transmission. Current infectious disease diagnostics are only used during the symptomatic stage of the infection, when an individual has been contagious for a period of time. The results take time to be delivered, at which point a patient is frequently in the recovery stage of the disease. We want to change this paradigm by enabling clinicians and individuals to test themselves at the point of need and read their bodies own immune system. This early detection would enable individuals to screen themselves, self-isolate or seek a therapeutic intervention early, potentially breaking the chain of transmission and improving health outcomes.   Our patented technology is still under development but has hit a number of key milestones. We have demonstrated that host biomarkers in saliva can be collected, stabilized, amplified and read out in a handheld device. Current development efforts are focused on improving the reliability of the assay, increasing the sensitivity of the assay, and addressing manufacturing concerns.  Host immune biomarker detection and readout is a new field that is under development for a number of applications, primarily sepsis detection and bacterial versus viral infection discrimination. We believe that disease agnostic home testing will give institutions and individuals a powerful tool to address the public health concerns of the future.

Our Go-to-Market Strategy

Darwin is currently developing the device in collaboration with the DoD for applications in improving warfighter readiness and pandemic preparedness. This market alone encompasses 2.91 million service members and civilians employed by the department. The target population for commercial use would be anyone who perceived that they might have been exposed to an infectious disease, or anyone ordered to take a screening test as part of an employment or travel obligation. We plan to access this population in a targeted manner, first identifying smaller markets that would benefit from screening services such as sports teams, military units, hospitals, and cruise ships. If we can achieve success in these markets that positively differentiates us from the standard of care, then we can start evolving broader public health perceptions to be more receptive to pre-symptomatic screening.  Currently, the market for host immune biomarkers and pre-symptomatic detection is in its infancy. There are few cleared products that use any derivatives of the technology, but several companies are raising money and developing products that seek to bring improved outcomes to critical care patients in hospital settings. We are differentiated because we are using host immune biomarkers in an easily available biospecimen (saliva) to bring improved health outcomes to point of care and point of need applications.

How We Will Generate Revenue

Darwin currently generates revenue through a development contract with the DoD. This relationship is likely to continue up until commercial clearance of SickStick, at which point we will transition to generating revenue from commercial sales. Darwin intends to partner with a commercial stage medical device company that has a a track record of launching IVD products for distribution activities. Our technology would be licensed to this partner, enabling Darwin to stay focused as an R&D entity and expanding our platform technology to additional indications.

How We Will Benefit From Destination Startup®

Darwin is currently seeking team members and strategic partners to help us realize our vision of a world with more accessible diagnostics. Team members that are passionate about innovation and working in a fast paced startup environment would be welcome additions to the Darwin team. Strategic partners that have demonstrated expertise in the following areas would be of interest to Darwin's business development: - IVD Manufacturing - Device Commercialization and Launch - IVD Sales and Distribution - Billing and Reimbursement

Our Team

Darwin currently employs a core team of eight scientists and operations professionals. Our R&D team has a strong track record of overcoming technical challenges and implementing innovative solutions as we refine our assay. They bring a depth of experience in genomics, diagnostic lab operations, virology and immunology. We additionally have a partnership with a premier diagnostic device developer, Orthogonal Diagnostics, who provides device design and manufacturing services. For professional services, Darwin contracts with top firms such as Cooley, VCFO, BHGR and CUBRC to advise and assist us as the company continues to operate and grow. This organizational structure allows Darwin to stay focused on agile R&D and keeps operating costs contained as our contract revenue varies.   We have identified several partners for manufacturing and commercialization and have initiated discussions to assess feasibility and potential structure of a long term relationship. Darwin has also had several discussions with BARDA, who has expressed an interest in our device's capabilities. Darwin believes that BARDA will continue to be a key strategic partner as our technology matures.