TBDx Progresses in India

Signature Mapping Medical Sciences (SMMS) personnel have recently returned from a two-week business development trip to India.  The trip had three primary objectives:

i.            Finalize the grant proposal to the Government of India, Department of Biotechnology (DBT);

ii.            Continue discussions with Dr Peter Small of the Bill and Melinda Gates Foundation that initiated during the company’s December 2011 trip; and,

iii.            Extend the knowledge and understanding of TBDx and its automated technology platform through meetings with newly-introduced and influential members of the international tuberculosis community.

On April 26th, a meeting of the Principal Investigators representing each of the three participating institutions, the Project Coordinator (Dr. D. Behera – LRS Institute), the Technical Advisor (Dr. S. Chadha – The International Union Against Tuberculosis), and SMMS personnel was held in the New Delhi offices of the LRS Institute of Tuberculosis and Respiratory Disease.  The meeting resulted in the finalization of the technical components and operating budget of a multi-site, nine-month project.  The proposed project contains three phases: (i) clinical evaluation of TBDxV (tuberculosis visualization software), (ii) development of automated detection algorithms for use in Ziehl-Neelsen (ZN) laboratory settings; and, (iii) clinical evaluation of TBDx for the automated detection of TB in ZN stained sputum slides.  On April 30th the final grant funding proposal was submitted to the DBT.  The timeline for review, determination and notification takes approximately 120 days from submission.

Grant Proposal Principal Investigators

Dr V.P. Myneedu – http://www.lrsitbrd.nic.in/

Dr Amita Joshi – http://www.grantmedicalcollege-jjhospital.org/

Dr Pratibha Narang – http://www.mgims.ac.in/

The Indian TB laboratory system is highly decentralized with an estimated 14-16 thousand laboratories operating throughout the country.  Many of these laboratories are performing few smear microscopy procedures, using the most rudimentary equipment and basic procedures.  Such decentralization of operations moves TB diagnosis closer to the point-of-care; however, during our December 2011 visit and subsequent email exchanges, Dr Small has questioned the effectiveness of a decentralized laboratory structure to positively impact the TB transmission rate.  Infrastructure development and the acquisition of sophisticated laboratory diagnostic equipment are far too expensive for most developing nations to rollout across a vast laboratory network.  As a result, Dr Small is interested in undertaking a project to demonstrate the potential of a centralized laboratory concept, one that he refers to as “a business and transport model.”  In this model, sputa specimens from remote areas are transported to centrally located laboratories outfitted with ‘best of breed’ technologies and staffed with the most experienced and talented microbiology personnel.

There are several keys to ensuring the project is successful – high throughput capacity, low cost-per-test, high sensitivity, quick diagnostic results with a capability to digitally transmit results in real-time – all features of TBDx.  We believe very strongly in the centralization concept and have expressed to Dr Small our sincere interest in participating in the project.  Dr Small has indicated that SMMS will play a continuing role in the concept development and rollout of the project.

Our final objective was to expand the number of influential healthcare professionals that know about and understand the potential impact of our TBDx technology.  When possible we met face-to-face with the individuals at their laboratories.  In other discussions the timing and logistics prevented this, which led to introductions over the phone.  Two discussions stand out among the many, that illustrate how quickly the individuals grasped the technology and demonstrated a high level of enthusiasm for what the technology can mean to TB and beyond in India.

Dr Amita Joshi oversees the microbiology laboratory of the JJ Hospital in Mumbai.  JJ Hospital is a participating institution in our DBT proposal.  She believes very strongly that the project will receive DBT funding because “our technology will revolutionize the way smear microscopy is performed.”

Dr Joshi quickly grasped the power and potential of our automation software platform, and its implications in the diagnosis of other diseases, such as Malaria and HPV.   At the top of her personal wish list is the development of an automated detection application for HPV.  Dr Joshi committed to undertake the preliminary data collection and image ‘truthing’ once SMMS commits to the application development.   Based on her domain knowledge about HPV, Dr Joshi was previously contacted by the University of South Florida to develop a database of images and patient data for HPV.

Dr John Kenneth – St. John’s Research Institute(www.sjri.res.in/) – also believes that centralization of the Indian TB laboratories would greatly improve TB diagnosis and speed drug therapy.  Dr Kenneth believes that without a high throughput screening technology, processing at a low cost per patient, the concept may never be realistic.  Based on our TBDx discussion, and feedback provided by other TB experts who witnessed the December demonstration of the technology, Dr Kenneth views TBDx as the technology to unlock the centralization concept and move it forward as a practical reality.

Dr Kenneth understands the inherent skepticism of the medical and scientific communities about new technology and has offered to further assist SMMS by performing a peer reviewed clinical study, to add to the TBDx resume.  He intends to write an evaluation protocol and secure an ethics approval from his organization.

Further, he is a member of the DBT advisory committee and will strongly recommend our proposal for funding.  Lastly, he intends to discuss TBDx with the leadership of the Central Tuberculosis Division who oversee TB laboratory operations, approve operational protocols, and sets regulations for government laboratories.

An unexpected benefit derived from the trip was delivered by Dr Sarabjit Chadha who is drafting a protocol and ethics approval document that will include TBDx in an evaluation project associated with The International Union’s Project Axshya, funded by the Global Fund.

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