Inventing the future from lab to life
Biotechnology & Biodefense
No single government agency controls the biodefense space, which makes it extremely difficult for newcomers to gain traction. We have worked extensively with all the major players (DoD, DHS, CDC, FDA, EPA, Intelligence Community, NIAID, etc.) and can help you plan to navigate the murky waters of government biodefense programs.
We have worked in many biotechnology niches, including point-of-care PCR, microarrays, CRISPR, and targeted DNA Sequencing. We can help you with technology, product, international marketing, and leadership aspects of your business in this dynamic and crowded field.
Food & Product Safety
We are on the verge of a tipping point that will require more proactive food and product safety, instead of relying on human cases to indicate that a problem exists. Are you ready for this major sea change in pathogen detection?
We were part of a team that mobilized in 2003 to help control a serious outbreak of Newcastle disease in poultry in California by developing PCR assays to distinguish vaccinated from infected birds. In 2010 we helped discover that a pediatric vaccine contained a pig virus contaminant. In 2018 we were brought in to advise the CDC on improved molecular technologies for detecting upper respiratory pathogens and for tracking food-borne diseases. We are well-versed on a multi-tier approach to detecting and characterizing food and product contamination by infectious organisms. Talk with us about your unique situation and needs, and how upcoming regulatory changes may impact your bottom line.
Human & Animal Health
Getting new diagnostic devices approved for human health usage in the US is a long and expensive road. Starting with animal health may provide you with a more rapid path to revenue and eventual acceptance for human health applications. Alternatively, international use may be another path to consider for easing eventual approval in the US. Talk with us before you commit to an approach, we may be able to save you from some expensive common mistakes.
We are in the early stages of beginning to understand how our microbiomes affect our physical and mental well-being. Whether the salient differences are found at the genus, species, strain, gene, or single-nucleotide variant level is still a research topic. Choosing the wrong resolution could be costly. Talk with us about your technology selection options.
Public Health & Surveillance
You are working on a product that could revolutionize public health, but how will you run the gauntlet of obstacles that face you, even if you are able to gain FDA approval? Or, you have a product that you believe could drastically improve biosurveillance for newly emerging pathogens. How do you gain traction in a skeptical marketplace?
Since 2000, we have had extensive interactions with multiple divisions of the CDC, several major state public health laboratories, and with nationwide bio-surveillance programs. We have experienced many of the hard realities that you will face, and we can help you meet them better prepared.