Table 3.

Overview of the steps followed by developers for diagnostic development

S no.	Characteristics	Diagnostic (Dx)
		Dx 1	Dx 2	Dx 3	Dx 4	Dx 5	Dx 6	Dx 7	Dx 8
	Targeted syndrome	Sepsis	Sepsis	Bacteraemia	Urinary tract infection	Identification of Pathogen and resistance markers	Urinary tract infection	Pulmonary and pleural tuberculosis (TB), TB meningitis	TB
i	Target product profiles (TPP) consulted for Dx development	No information shared by developer	Yes, FIND*	Yes, WHO*	Yes, WHO*	Yes, FIND	Yes, FIND*	Yes, WHO	Yes, WHO
ii	Standard or guidelines consulted to evaluate performance parameters		Yes, CLSI, ISO	Yes, CLSI	Yes, CLSI	No	No	Yes,	No
iii	Time taken for diagnostic development (in years)		3.5	4	4	3	3	8	3
iv	Approximate grant for diagnostic development (in USD)†		Approx 100–150 k	100–150 k	221 197 200–250 k	350–400 k	150–200 k	200–250 k	200–250 k
v	Source of funding	Government, industry and non-profit organisation	Government and multiple collaborators	Government and industry	Government	Government	Government	Industry	Industry
vi	Whether Dx submitted in National Healthcare Innovations Portal (NHInP)‡	No	Yes	No	No	No	No	No	No
vii	Diagnostic development team	Biochemist, biochemical engineer	Biophysicist, biochemist	Biophysicists, molecular biologist	Medical biochemist molecular biologists, engineers	Biotechnologist, molecular biologist, engineers,	Biotechnologist, biochemist, molecular biologist, microbiologist, critical care clinician, engineers	Biotechnologist, molecular biologist, protein biochemist, virologist	Biophysicist, biochemist
viii	Key challenges in progress	Absence of gold standards Samples for validation of markers Multisite-field validation Regulatory challenges Cost effectiveness studies	Absence of TPP, gold standards Standards of evaluation and product validation	Limited opportunity for engagement with regulators	Multisite validation	Standards for validation Difficulties in the availability of samples for validation	Multisite field validation	Multisite field validation	Completing regulatory approvals

* A TPP on ‘Simplified Blood Culture’ is available from FIND but no separate TPPs are available for sepsis or neonatal sepsis either from FIND (https://www.finddx.org/tpps/) or WHO. TPPs on guidance on therapy for different syndromes/conditions are available from WHO (https://apps.who.int/iris/discover?query=Target+product+profile). TPP for antibacterial resistance diagnostics and uncomplicated enteric fever is published in 2020 by WHO.¹⁹

†Conversion rate US$1=72.34 as on 24 February 2021; the cost of diagnostic development is self-reported by the innovator/developer.

‡(NHInP aims to provide innovative programmes designs, practices, technology solutions and products across public and private healthcare sector of India. National Health Systems Resource Centre under the National Health Mission of Government of India serves as its technical secretariat. Link to NHInP https://www.nhinp.org/index.php.

CLSI, Clinical and Laboratory Standards Institute; FIND, Foundation for Innovative New Diagnostics; ISO, International Organization for Standardization; NA, not applicable.;