Nanobiosym (NBS) commits to accelerate the validation, launch, and uptake of NBSs XPrize winning Gene-RADAR technology platform to provide resource limited settings with the tools and data necessary to prevent, detect, and rapidly respond to an Ebola outbreak before it becomes a pandemic. This commitment will involve a multi-phased approach that will fully leverage the breakthrough Gene-RADAR platform (for real-time, point of care, fully automated, quantitative, presymptomatic Ebola diagnosis) to create affordable access and adoption to the countries and programs in the most urgent need. NBS will pilot this work in Liberia but eventually hopes to make this technology available to all countries interested in building the capability to rapidly respond to Ebola and/or other infectious disease outbreaks.
The first phase of work will involve a clinical trial in Cambridge, MA where the technology will be evaluated against the current gold-standard diagnostic technology (large, expensive, and technically complex polymerase chain reaction machines) and optimized for the West African context. Upon locking in the final design NBS will manufacture a small batch of devices and chips to support field based validations trials in Liberia. These trials will be conducted by partners on the ground in Liberia under the overall purview of NBS. NBS has already begun outreach to potential partners such as Medicines Sans Frontiers, the World Health Organization (WHO, and local governments and labs) to secure samples and contribute to designing a trial that will support local registration and develop the standard operating procedures needed to integrate this novel diagnostic into current outbreak preparedness, containment, and treatment protocols. Local registration will trigger larger scale manufacturing to support a first phase of deployment to 50 healthcare centers / posts across the country (specific locations will be determined in conjunction with the Ministry of Health (MoH) in Liberia and other partners supporting the countrys Ebola program (e.g. MSF). NBS will also develop a training program and associated materials to ensure health care workers have the right tools and knowledge to use the device, interpret the results, and collaborate with care givers to implement the appropriate containment, treatment, and contact tracing measures. As with the selection of sites for deployment, decisions on the final number and type of worker to be trained will be made in conjunction with the MoH and other partners, however, NBS would like to ensure that at least one health care worker per device (~50) is trained and able to train other staff in their local area on appropriate device use, result interpretation, etc. Per the WHO, Liberia has approximately10 health centers per 100,000 people; deployment across 50 centers is therefore expected to provide access to testing for 500,000 people. Down the road, as NBS develops additional applications for the platform these same devices will also provide patients with access to testing in other disease areas such HIV and TB.
The most significant challenge to this program will be coordinating and managing the in-country clinical trial program and obtaining the necessary licensures to import and sell the NBS Gene-RADAR device in Liberia in a timely manner. NBS would like to run the in-country program with the support and buy-in from the MoH and leverage existing laboratory infrastructure and staff to run the comparisons tests on existing machines. However, if this is not possible NBS is prepared to work with other on the ground partners to achieve the same goals. NBS will also be reliant on the countrys internal registration processes to import the product for commercial use which may take time. However, again, NBS will also work closely with the local government and partners to explore options to import the product via a waiver or on a compassionate use exemption to ensure the devices and tests are deployed in the timelines of this commitment.
This Commitment will exponentially increase access and dramatically multiply both the economic and health impact of this exciting new technology and catalyze a revolution in how Ebola and, eventually, any disease with a genetic fingerprint (including HIV, TB, Malaria, Flu, HCV etc.) is managed globally.
As mentioned above, the commitment will be implemented over a series of phases marked with specific deliverables:
Phase 1: US (Boston) based pilot study
- 2016Q1 Pilot study designed and samples sourced; pilot study devices and chips manufactured
- 2016Q3 Pilot study completed and data analyzed
- 2016Q4 Final device and chip design and locked down
Phase 2: In-country (Liberia) validation study and SOP development
- 2017Q1 Validation trial design finalized; memoranda of understanding (MoUs) and IRBs in place; manufacturing of validation study devices and chips begun
- 2017Q2 Validation trial under way
- 2017Q4 Validation study complete; data analyzed; regulatory dossiers submitted
Phase 3: Manufacturing scale-up-
- 2017Q4: Manufacturing for commercial devices and chips begun
- 2018Q2: Manufacturing of commercial devices and chips completed
Phase 4: Health Care Worker (HCW) training
- 2018Q1 HCW training program and materials developed
- 2018Q2 HCW training program piloted and adjustments made
- 2018Q3 HCW training program rolled out to ~50 healthcare workers (HCWs) across ~50 facilities
Phase 5: Device and chip deployment to 50 health care centers / posts across Liberia
- 2018Q1 Procurement plans (and associated financing) in place
- 2018Q2 First orders placed
- 2018Q4 Devices shipped to designated health care centers / posts
According to the WHO, between December 2013 and July 2015, there were over 27,000 suspected, probable, and confirmed cases of Ebola and over 11,000 deaths across 11 countries and three continents. This recent outbreak exposed critical gaps in many countries current capabilities for detection, diagnosis, treatment, infection control, and surveillance of dangerous diseases like Ebola. One of the most challenging issues confronted by containment efforts was the lack of access to a low-cost diagnostic test that can be deployed widely across West Africa that can provide timely test results for health care workers and patients on the front line. Going forward, therefore, there is an urgent unmet need for affordable, point-of-care (POC), diagnostic combined with a genomic infectious disease surveillance program to support rapid triage of patients with signs of an acute febrile illness to enable rapid decisions around isolation, treatment, and contact tracing needs.
Nanobiosyms (NBS) revolutionary flagship product, Gene-RADAR (Winner of the 2013 XPrize), provides a quantum leap in capabilities to i) detect Ebola in patients even in the pre-symptomatic phase, ii) perform real-time contact tracing through our cloud-based global infectious disease surveillance system, and iii) provide quantitative viral load monitoring of the disease. The Gene-RADAR platform harnesses NBSs breakthrough nanobiophysics innovations to provide a quantum leap in capabilities to detect Ebola much earlier than currently possible and enable real-time contact tracing and quantitative viral load monitoring. Gene-RADAR enables the low cost detection and quantification of disease load, without the need for laboratory infrastructure, trained healthcare personnel, electricity or running water a key unmet need in the resource limited settings where this technology will be deployed.