AT1 0.00% 2.5¢ atomo diagnostics limited

Ann: DIVOC Labs to sell Atomo's COVID-19 test in India, page-26

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    India govnt has delgated 'India Council of Medical Research' to test and approve all Covid19 medical methods/materials/kits
    https://www.icmr.gov.in/

    Front page is nicely divided into categories about what they do, are doing + a count of testing rates vs samples etc

    As of 4 Sept 2020, this is the list of approved AB test kits (only 23 approved out of 142 submissions) - that's the current Divoc-AT1 competition
    https://www.icmr.gov.in/pdf/covid/kits/Antibody_based_tests_04092020.pdf

    Just for the future - if an antigen kit with AT1 device ever comes into play, this the AG test competition (4 approved out of 24 submissions)
    https://www.icmr.gov.in/pdf/covid/kits/List_of_rapid_antigen_kits_15092020.pdf

    The India regulator approval certainly seems much tougher to pass than the US FDA one....in US, one can grandfather a test/device in as long as its substantially like any other previously approved item (core basis for FDA EUAs) or just show efficacy in a small clinical trial to get selling (and FDA pops a disclaimer that X item is still not comprehensively tested yet)

    Last edited by FinFree101: 23/09/20
 
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