During the two week period ended December 17th, executives from Signature Mapping Medical Sciences traveled to India as part of an overall strategy to establish TBDx in India. The strategic objectives for the trip included the following:
- Demonstrate the TBDx fully automated hardware-software technology platform to as many TB stakeholders as possible. This is a key objective for penetrating any new market. Interacting with the technology creates the ‘wow factor’ that cannot be achieved by simply discussing its capabilities.
- Affect healthcare policy, with respect to TB diagnostics, by meeting with and educating key ministers in healthcare and technology.
- Establish key business relationships with private Indian companies to accomplish important goals and needs:
- Marketing & sales support.
- Installation, training and maintenance support.
- Joint project proposal efforts aimed at securing R&D project funding.
- Joint venture with an Indian company to deliver TB diagnostics via mobile vans.
- Meetings with key government healthcare officials to develop governmental funding for R&D projects.
- Meeting with the Wellcome Trust Director of Operations in India to discuss our grant proposal, timing, and expectations.
We successfully accomplished each of the above objectives and, in addition, established valuable new contacts, advocates and opportunities. Interest was so high and created a significant amount of post-trip follow-up activities, including a return to India during the latter part of January or early February.
We accomplished approximately twenty group demonstrations of TBDx to approximately fifty individuals. Included in the demonstrations:
- Top government healthcare officials from both the Central and State levels,
- Apollo Hospitals Group www.apollohospitals.com,
- All India Institute of Medical Sciences www.aiims.edu,
- The International Union Against Tuberculosis and Lung Disease www.theunion.org,
- Carl Zeiss Microscopes www.zeiss.com,
- Foundation for Innovative New Diagnostics www.finddiagnostics.org,
- The Bill and Melinda Gates Foundation www.gatesfoundation.org,
- Department of Biotechnology www.dbtindia.nic.in,
- LRS Institute of Tuberculosis & Respiratory Diseases www.lrsitbrd.nic.in,
- World Health Partners worldhealthpartners.org,
- Gennova Biopharmaceuticals Ltd. www.emcure.co.in,
- Prosix Softron PVT. LTD www.prosixsoftron.in,
- DSS Image Tech www.dssimage.com,
- Oncquest www.oncquest.net.
The overall reaction to the demonstrations was overwhelmingly positive with comments ranging from: “wow” to “why do you need auto-detect when the images are so sharp and clear” to “how do I get this technology now!” Since most, if not all of the institutions, were unaware of our technology and now have a strong desire to deploy TBDx within their laboratories, ramping up their budgets to support hardware procurement will be a key activity. As we move forward it will be important to develop finance/leasing options to spread the costs over a longer period of time.
Most discussions about the technology centered on a couple of key areas.
- First and foremost was the impact that TBDx could have on reducing the number of false negatives (missed positive cases of TB). Using auto-detect algorithms like those used for Auramine would very obviously impact this problem. However, most groups were interested in what we thought the reduction would look like using only the visualization technology for Ziehl-Neelsen (ZN). Since we had no supporting clinical data to address the question, most groups assumed that it would have a significant impact, but would need to be determined by a clinical trial.
- The second most common question was the ability of the technology to detect extra-pulmonary TB. Again our response was that we believe it to be possible, but that we have not undertaken a project to develop the algorithms.
- Lastly, it was suggested that we submit a grant proposal to do research and development on the detection of the bacilli using ‘vital stains’. Vital stains would eliminate the need for ZN processing thereby reducing the cost and time to diagnose.
Our goal was to develop a buzz about the technology and we definitely accomplished it. Most of the scientists did not believe that automated image capture of stained TB slides could ever be accomplished due to inherent image acquisition challenges, the vast variations in slide staining quality and without using oil immersion. Seeing TBDx was definitely believing!
From our efforts we have been invited to participate in several large clinical trials with implications for an endorsement from the World Health Organization. In addition, we have multiple organizations interested in submitting joint R&D grant proposals to various funding agencies. We have also commenced the negotiations with several private organizations to provide sales, marketing, support and joint venture business opportunities. Listed below are highlights of a few of the meetings we held.
Our meeting with the International Union Against Tuberculosis and Lung Disease (IUATLD) went very well. The ‘Union” was impressed with the clarity of the ZN images and was very interested in assisting the company further evaluate the technology in India. Conference calls have been scheduled in early January to discuss the role IUATLD could play in introducing our technology into the Indian market.
During our presentation to the Foundation for Innovative New Diagnostics (FIND) a question arose about our ability to interface with microscopes manufactured by Carl Zeiss Microscopes. Since we have been unable to gain a working arrangement with Zeiss’s headquarters, the FIND representative urged key local Zeiss representatives to experience the technology. The Zeiss representatives immediately grasp the technology and its importance to TB diagnostics in India and beyond, and will be discussing the technology with headquarter officials in Geneva. All parties agreed that we should develop a solution using the WHO-endorsed Zeiss iLED Primo Star Microscope. Currently we are making arrangements to have a unit shipped to our office for evaluation and integration.
Although organizations such as the Bill & Melinda Gates Foundation (BMGF) see molecular diagnostics (Xpert) as the future in TB diagnostics, they acknowledged their mission to use any technology that will help fight the TB pandemic. Because sputum microscopy is well-established and a low-cost solution it will remain a vital diagnostic tool particularly in resource poor countries. BMGF was intrigued by the role that TBDx could play in larger, more centralized labs where sputa is delivered for processing and the analysis and reporting is fully automated. Clinical trials to test the efficacy of a centralized delivery model (India is currently very highly fragmented in its laboratory landscape), using our technology for high volume processing of ZN stained specimens, is currently under discussions and will be a main topic upon our return to India.
In conclusion, we conducted a meeting and demonstration with the Wellcome Trust. Of primary interest to us was the status of our grant funding proposal. The Wellcome Trust explained our funding proposal had not been processed giving an explanation that it was due to an untimely filing (fact – it was an error on their end, not ours).
There was very encouraging news however, after viewing the TBDx system and its processing capabilities, The Wellcome Trust strongly encouraged us to resubmit our proposal. We discussed potential modifications to our original application which were heartily endorsed. We were personally ensured that our application would be processed in June 2012. While this is not the outcome we wanted, a relationship with The Wellcome Trust is extremely valuable to our efforts in India and beyond. We intend to submit our proposal by the 28th of January.