3C Bio, Inc.

Our mobile laboratories are fully self-contained facilities designed to quickly test a large asymptomatic population for the SARS-CoV-2 virus and for antibodies to the virus. 

We aim to deploy mobile high-throughput semi-robotic diagnostic labs to the location of large numbers of workers, travel passengers or event patrons so they may all be tested on location to prevent infection. For periodic screening, on-site deployment provides the quickest results and most effective logistics. For outbreaks, providing massive throughput on-site enables testing an entire group in one day, clearing those who test negative so they can get back to work the next day and correctly identifying essentially all asymptomatic infected individuals for quarantine. To reopen sporting events, concerts and cruise ship travel, massive-scale testing on-site at the stadium or port will be the most effective way to provide assurance that everyone has been recently tested and cleared.

COVID-19 has become a global pandemic, affecting all people across the globe. There does not currently exist a robust plan to test and clear large portions of the population. Test availability is still anemic, with some waiting days for a result. The high risk of SARS-CoV-2 passing between essential workers from asymptomatic carriers leaves crucial supply lines for food, medicine and personal protective equipment vulnerable to collapse. Clinical lab testing incumbents have infrastructure that prioritizes patient care but is a poor fit for clearing workplace, travel and recreational settings of asymptomatic infected individuals. Extensive, rapid and repetitive testing is required onsite, especially for the over 55 million essential workers in the US. 

Our initial target markets are businesses and governmental entities worldwide that need to bring large numbers of people together to operate effectively, shifting to non-essential workers and then recreational use cases as the pandemic becomes less severe. Specific use cases are: food processing and manufacturing plants, critical global logistics, aviation/transportation, defense, government, healthcare/emergency response, non-essential workers, sporting events/concerts, cruises and eventually building a pandemic reserve of rapid response units to ensure that we are properly prepared for any future outbreak.

The complete testing system has two complementary elements to diagnose SARS-CoV-2:

1. Automated robotic RT-qPCR testing for the virus. RNA detection via reverse transcriptase quantitative polymerase chain reaction is the gold standard for identifying subjects currently infected with SARS-Cov-2 with high sensitivity and specificity. 

2. Fast point-of-care IgM/IgG serology testing for antibodies to the virus. Positive results indicate that the subject has antibodies to SARS-CoV-2. Dual IgM (initial response antibodies) and IgG (enduring response antibodies) testing is informative, but does not distinguish currently infected versus recovered from the infection. 

Combination RT-qPCR and serology testing distinguishes individuals as either:

• not infected
• currently infected or
• previously infected and recovered.

The combination improves sensitivity and specificity over either method alone by reducing the probability of a false result. 

3C Bio will build its mobile laboratories according to a consistent design in compliance with BSL2+ guidelines and in adherence to CLIA standard operating protocols. The initial build time is estimated at three weeks, plus an additional three weeks for regulatory certification. 

Our standard lab design is capable of processing 2,400 samples/day with reporting back on test results within 24 hours. 

Food processing and Manufacturing Plants

Smithfield Foods has indefinitely closed a pork processing plant that employs 3,700 workers and accounts for 4-5% of the country’s pork supply after 300 tested positive for SARS-CoV-2. Such closures acutely threaten the U.S. food supply. 3C Bio will initially target food processing, pharmaceutical, and medical manufacturing plants, later progressing into less critical industries including electronics and semiconductors. Two 3C Bio laboratories could clear a manufacturing plant of similar size in a day on-site.

Critical Global Logistics

Testing longshoreman, port and warehouse operators that serve critical global supply chains. We aim to clear ports with labs traveling up and down the coasts, screening and clearing workers.  

Aviation/Transportation

We intend to test pilots, flight attendants, baggage handlers, customer service representatives, TSA workers, shuttle bus drivers, taxi, Uber and Lyft drivers, and rental car company staff, and/or passengers.

Defense 

The COVID-19 outbreak aboard the USS Theodore Roosevelt highlights the  challenge of maintaining a crew of thousands of sailors in close quarters free of infection. 3cBio employs a 40’ containerized lab is design for defense and overseas operations. These labs fit in a C-130 transport plane and can operate on roads anywhere in the world. 

SARS-CoV-2 is the fourth major respiratory virus to break out in the past two decades. It will not be the last. Governments across the globe now recognize the need for building and maintaining capacity for future pandemic prevention as necessary insurance in order to preserve lives, livelihoods, and strategic readiness. There is urgent need for onsite testing  for quick response and enabling access to testing for communities that need it the most. After this pandemic passes our testing infrastructure will have a steady business supporting governments as they seek to maintain readiness for preventing future outbreaks from progressing to pandemics.

The 3C Bio technology platform employs automation via a reconfigurable robotic pipetting machines platform and RT-qPCR detection, integrating open-source systems that have been previously approved under Emergency Use Authorization (EUA) by the FDA. 3C Bio labs will generally be deployed on-site in workplace and recreational settings, with sample collection conducted at drive-thru or walk-up stations set up under tents.

3C Bio current laboratory technology platform is built on the integration of open source laboratory hardware. We have identified additional approaches in development that could provide unique benefits, and we are currently engaged in productive discussions regarding 3cBio obtaining proprietary rights to deploy these technologies in mobile laboratories.

In the United States 3C Bio will operate under state authorization and CLIA Registration. All labs will be built to BSL2+ specifications. Outside the United States the company will sell fully operational ISO-15189 certified laboratories; overseas customers will be responsible for additional compliance requirements in their own jurisdictions. The company’s certification strategy is based on an innovative approach pioneered by the Doudna lab at Berkley, as summarized in “Blueprint for a Pop-up SARS-CoV-2 Testing Lab” doi: https://doi-org.ezproxyberklee.flo.org/10.1101/2020.04.11.20061424. This team employed several innovative approaches made possible by increased flexibility and expediency at the state and federal levels for certification and licensure requirements to achieve certification in just three weeks. The process accelerates CLIA Registration by establishing partnerships with existing labs through which the new lab is filed as an extension of the CLIA certification of the partner.

The customer is greeted and personal data is entered via a smartphone app data and confirmed by the greeter, before a blood test and nasal swab sample are administered by a medical worker. The nasal swab sample tube and blood test are linked to the customer via scanned QR code and delivered to the lab via a collection window. In the lab hood a technician transfers the samples to 96-well format for robotic sample preparation and RNA extraction. These steps are performed in an automated manner using nine pipetting robots, and then the viral levels are read out in an RT-qPCR instrument. Sample results are then automatically uploaded into the data management system, and the testing subject (and employer, if appropriate) are notified.

Our standard lab design with pipetting robots and RT-qPCR instruments is capable of processing 2,400 samples/day. These systems are able to return test results as early as 6 hours from sample collection. When running 24 hours/day but collecting samples over a 12-hour sample collection period, on-site freezers are used to maintain sample fidelity. 

Test results will be managed via a HIPAA compliant IT system that will notify the customers of their results through a web application. 3C Bio systems with integrate with required CDC reporting and contact tracing programs operating with of data integrity and privacy. 

All technology being used is already implemented under Emergency Use Authorization by the FDA in other contexts. We are merely integrating automated robotic pipetting machines to increase the throughput of samples, and placing the laboratory in a mobile container or trailer under a CLIA registration stemming from an already CLIA certified laboratory.

See a listing of all approved diagnostic tests here:

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations

Current similar competitors include GermFree, a company that creates mobile laboratories. Unlike GermFree, 3C Bio is able to build labs faster, more cost-effectively, and has the ability to operate the laboratories in a multitude of environments.

The world is now a very different place than it was just a few months ago. There is now a pervasive low-level consistent fear of gathering in groups due to the potential of future outbreaks, pandemics and biological agents causing unseen harm. To the detriment of the global community, humanity was caught wrongfooted by COVID-19 at exactly the perfect time. In the US, there has been no coordinated plan of action; no leadership to bring about an end to this crisis. Luckily, a confluence of adaptable emerging technology, fast action, and coordinated response by local communities has helped stave off the worst of the virus.

We need something better. We need to live in a world where there is no fear of biological agents causing terror and disrupting lives - where there is an existing plan of action, quick response, and dedicated solution to solve the problem of outbreaks to put a stop to them before they become pandemics.

Our mission is to eliminate the fear of spreading unseen infectious diseases. Key to our theory of change is to turn the invisible visible. The more that we enable testing of asymptomatic individuals in the population, the more we are able to limit the transmission of a disease. 3C Bio seeks to identify outbreaks at the source, develop tools to quickly control and contain the spread of a deadly disease, then partner with other organizations to fully eradicate infectious diseases. 

Our solution does not serve anyone yet. We are currently seeking domestic customers through direct purchase of laboratories abroad, leasing laboratories to diagnostic facilities domestically, with the goal of eventually operating diagnostic laboratories within the United States.

Within one year, we aim to operate a small fleet of laboratories within the United States to test onsite for COVID-19. For each laboratory, we would be able to test 2,400 people per day. This means that for a small fleet 10 labs, we'd be able to test 720,000 per month over the course of the pandemic.

Within five years, we aim to be the main response system for outbreaks around the globe. Rapid on-site diagnostics has the potential to save lives, and we aim to eventually scale to offer local testing to everyone in the US, with laboratory units being sold to foreign countries in the event of outbreak elsewhere.

The most immediate goal is to get to perform a first diagnostic test. 3C Bio aims to do this through a minimum viable product: a mobile van that is equipped with two robots and a qPCR machine. This enables 3C Bio to partner with existing organizations, start gaining some revenue, and demonstrate the value of the mobile laboratory design. 

During the next month, 3C Bio aims to raise a $2 million seed round to accelerate the delivery of labs to foreign clients. There are a number of pending deals with foreign ministries of health, and with some initial financing, 3C Bio would be able to fulfill those contracts.

Throughout the year, the team aims to consistently build laboratories, deploying them onsite to test and clear areas that are experiencing outbreaks.

In the subsequent five years, the business model will shift to pandemic reserve, most likely selling the business to a large government contractor or existing laboratory diagnostic incumbent to consistently operate these mobile laboratories as a method of defense against future outbreaks.

There is a distinct regulatory barrier associated with building a diagnostic laboratory. This comes in the form of CLIA-certification. CLIA is normally a multi-month process that has been shortened during the pandemic. Currently the FDA offers CLIA registration which serves as an extension on existing CLIA-certified and operating diagnostic laboratories. Getting CLIA registration, then eventually CLIA certification is the process by which 3C Bio can certify the entire fleet of mobile laboratories for diagnostic testing.

The second barrier comes in the form of financial. This is a capital-intensive business that takes $100,000+ to get started building the first lab. It is difficult to convince investors that the business has merit post-pandemic, despite the huge revenue potential.

The third barrier comes in the form of the market, particularly market speed. By the time 3C Bio builds the first laboratory units, the testing capacity in the US may have been fulfilled. 

Regulatory:

The FDA has allowed the establishment of CLIA-registration which serves as an extension on an existing CLIA-certified laboratory. This means that 3C Bio can obtain CLIA registration through partnering with an existing established CLIA-certified diagnostic laboratory. This speeds up the process for obtaining approval, and allows for potential revenue generation by adding capacity to an existing CLIA diagnostic laboratory. In addition, 3C Bio has brought onboard an experienced CLIA-certified diagnostic laboratory operator to serve as a lab director. 

Financial:

3C Bio aims to build a minimum viable laboratory first, and/or leverage existing CLIA diagnostic laboratories to set up equipment to begin testing. This enables the team to reach market without as much of a capital requirement to showcase a proof-of-concept. To assuage investor concerns, the team offers clear evidence of huge revenue potential, and in a post-pandemic world, either a large exit and/or a consistent steady source of revenue from maintaining pandemic readiness. The team has been seeking alternative sources of financing beyond venture capital that may find this offering more alluring.

Market:

It is difficult to ascertain the future of the SARS-CoV-2 diagnostic market. Currently, there are no established mobile diagnostic laboratories that are testing at-scale. This indicates there is still a distinct market need for this solution, and based on customer demand in foreign markets where they lack existing laboratory infrastructure, 3C Bio's solution will consistently be needed.

4 Full-time staff

7 Part-time staff / contractors

Mark J. Mendel, Ph.D., President and CEO

Previously with Broadmark Capital, co-founder of RiverVest Venture Partners, and Kauffman Fellow at ARCH Venture Partners. Dr. Mendel has worked in product development at Analytix, a startup that developed a robotic blood chemistry analyzer and as a lab tech in the blood gas laboratory at Children's Hospital of Philadelphia. Bioengineering PhD, University of Pennsylvania; BS, Cornell.

David Therrien, Chief of Strategy and Operations

David Therrien’s work as an entrepreneurial technologist leading major art projects sits at the intersection of biological processes, information systems, and engineering. He brings decades of experience leading large teams with engineering and project management staff to design and build multi-million-dollar technological installations. He has designed, built, lived and worked in containerized residences and studios. Sponsors of Therrien’s work have included Apple, Warner Bros, and the Rockefeller Foundation.

Elliot Roth, Director of Research

Trained at the Stanford Design School, Elliot studied synthetic biology for 12 years and worked for five years as a product consultant. He has launched seven startups, including Spira, Inc.; built five laboratories; and founded two nonprofits. BSc Biomedical Engineering, Virginia Commonwealth University.

Jordan Beer, Fabricator

Jordan Beer is a certified welder, welding inspector, and CAD drafter. He has specialized in building prototypes at makerspaces and incubators in Austin and Los Angeles. Jordan’s team won the SpaceX Hyperloop Innovation Award in 2017 and 2019.

Advisors and Professional Service Providers

Lab Automation   Will Canine, Opentrons Labworks    

Architecture          Lauren Leatherbarrow AIA, Nate Hoffman AIA,

and Rich Olay AIA, OZ Collaborative

Legal                     Kris Brown JD, Goodwin Proctor, LLP

Accounting           M.B. Petruska, Petruska Accounting Services

Finance                 Vijay Raghavan, CFO, AGC Bio, Inc.

Medical                  Jason Goldman, M.D., Swedish Hospital Department of Infectious Disease

Regulatory            American Association of Lab Accreditation

3C Bio has a three-tiered method of making money:

• 1.Direct sales of mobile labs and reagents for use outside the United States (and within the US on a limited basis as part of the company’s go-to-market strategy).
• 2.Leasing mobile labs on a limited basis as part of the company’s go-to-market strategy.
• 3.Per test fees.

3C Bio primarily intends to sell and operate its testing services throughout the United States under CLIA certification, and will sell its laboratories for use and operation by others outside the U.S. International buyers will be responsible for the management of the labs they purchase and the fulfillment of the regulatory requirements of their respective countries.

Build Cost of a Lab

  < $600,000

Monthly utilization

                15 days/month

Daily utilization

            1000 samples/day

Selling Price

            $200 1/test

Revenue

>$3,000,000 1/month

Table 2. The unit economics for 3cBio’s laboratory are compelling:  each lab can generate monthly revenues >5X the build cost (Bill of Materials plus build labor) with modest utilization assumptions.

Go-To-Market Strategy

We are in discussion with several CLIA certified labs that could serve as partners for getting our mobile labs approved, and would also enable 3cBio to begin commercial operations prior to completion of the construction of our first mobile lab, by operating our testing equipment under FDA EUA in their existing laboratories. In this scenario, we estimate that we could begin commercial operations in less than five weeks post-funding, initially sending samples to a partner lab.

A second component of the company’s go-to-market strategy is selling and leasing labs in the US to CLIA certified laboratories for the customer to take through certification themselves.

3C Bio projects rapid profitable growth in lab sales and testing sales during the pandemic. As the pandemic begins to wane, we expect explosive growth in testing volumes as the use of our testing shifts to recreational markets, such as arena sporting events, concerts, and cruise ships. Post pandemic, we project a decline in revenues as the business shifts once again to a government contracting business to conduct respiratory virus surveillance and maintain strategic reserve capability.

The model projects profitability in 2020. The following summary of 3C Bio’s pro-forma P&L is based on revenue per test of $200 and testing volumes of 1,000 samples/day-lab for tests performed in the United States, and a selling price of $1,500,000 /laboratory for units sold internationally. These projections are speculative given the early stage of development of both the Company and market.

We are applying to SOLVE because, we envision 3C Bio as being the fast-response monitoring system to provide a safeguard against harmful pathogenic activity. Viruses, microbes and other infectious agents spread unseen among the population. Transmissible infectious diseases are still one of the leading causes of preventable death. Part of the reason that these diseases still persist in the modern era is due to their unseen asymptomatic transmission. This will only get worse as the risk of the intentional spread of infectious disease as an agent of terror increases every passing year.

Sun Tzu said: “If you know your enemy, and you know yourself, you can fight 100 battles without disaster.” Humanity’s battles against these pathogenic enemies have been unsuccessful because it is difficult to know an enemy that is invisible, and it is not in human nature to confront this kind of enemy. There are only two infectious diseases that have been eradicated: smallpox and rinderpest, and those diseases still have the threat of being revived as a bioweapon. Four more ongoing programs for poliomyelitis, yaws, dracunculiasis and malaria have been unsuccessful and are still pervasive after millions spent. People are prone to gather in large groups, are short-sighted and often only believe what can be seen.

Without 3C Bio, the world is a much less safe place. We're particularly looking to the SOLVE network to help us prototype, raise capital and connect to advisors that can help us scale.

We aim to partner with MIT Faculty, particularly those experienced in virology and/or diagnostics at MIT medical and Safe Paths (a contact tracing app).

These MIT community members would be excellent partners to deploy these mobile testing labs into the global community by partnering on building diagnostic protocols, developing software to enable contact tracing, and deploying into communities. In particular:

Lee Gehrke at E25Bio to utilize their paper-based assay for SARS-CoV-2 and Feng Zhang for their point-of-care diagnostic for SARS-CoV-2.

Our basic assumptions are that:

1. Infectious diseases are going to get worse unless there is some planned coordinated response to confirm, contain, control and then eliminate outbreaks
2. The best planned response is quick, onsite, decentralized and adaptable to multiple contexts
3. Routine and consistent testing for pathogenic and infectious agents will eventually become normalized to identify and treat asymptomatic individuals

Key to our assumptions is a comprehensive plan to first confirm, then contain, control and finally eliminate the infectious disease outbreak. This forms the basis for our response to any future pandemic.

Confirm: 3C Bio seeks to be the first responder to the scene of an outbreak, testing en masse in a cost-effective way. 

Contain: 3C Bio aims to build software systems to enable safe and effective quarantine, contact tracing and credentialing to prevent the spread of disease. 

Control: 3C Bio plans to share information to understand diseases through cutting-edge testing protocols that track data securely, creating new information on how to best predict the transmission and progression of infectious diseases.

Eliminate: 3C Bio will partner with healthcare organizations to deploy vaccines, therapeutics and the like to eliminate infectious diseases. 

With the Elevate Prize for Health Security, we'd be able to connect with partners to enable these steps, and build our first prototype labs to ensure a safer, healthier world.

The team will specifically focus on using the Andan Prize for Innovation in Refugee Inclusion Prize to deploy our mobile laboratories to developing countries, particularly those that are being affected by the virus but lack the ability to properly test their populations.

The team has raised $50,000 so far from the WeFunder XX Accelerator by being one of the 11 teams selected out of 2500 applicants, and has the ability to launch an equity crowdfunding campaign through their website.

The team will specifically focus on using the Future Planet Capital Prize to deploy our mobile laboratories to developing countries.