Experts deliberate on developing affordable diagnostic tools and need for clearer regulatory pathways at an event held in Mumbai

LThe conference on 'Technological challenges in developing affordable in vitro molecular diagnostics', organized by Yashraj Research Foundation and Mahatma Gandhi Mission (MGM) in Mumbai, brought together renowned scientists on one platform. Discussions at the event revolved around technological advances made in developing more sensitive, specific and predictive methods for healthcare diagnosis. They also discussed how these methods can be made more affordable for the poor.

Interesting topics of discussion, included crossroads and technology options in in vitro diagnostics; true faces of biomarker discovery; opportunities and challenges in developing and implementing diagnostics in low-resource settings; new platforms in cancer diagnostics; low cost point-of-care tests for infectious diseases and challenges in affordable multiplexed diagnostics. Industry experts also said there was an urgent need for a clear regulatory pathway for approval of diagnostic tool products. They sought a change in the way approvals of such products are given by the DCGI.

Furthermore, any indigenous diagnostic tool developed by an indigenous company or academic institution has to go through a validation process conducted by an independent team (this is apart from the in-house validation procedures conducted by the company itself), the guidelines for which again are not clearly defined. Experts also opined that there should be a separate window for diagnostic tools' approval within the DCGI.

Nayantara Som Banerjee in Mumbai