Are the basic scientific principles observed?

Is the need for a new biomarker identified?

Is the need for a new algorithm identified?

Are the therapeutic target and its role in the disease identified?

Is the technology concept/application formulated?

Has the experimental essay for detection of the biomarker have been designed?

Have low-level experiments been designed and run to analyse model/algorithm properties?

Is it demonstrated on an initial level by in vitro studies that the molecule target is involved in the disease and that its modulation is likely to have a therapeutic affect?

Has (animal) testing started to prove the concept/application?

Has the biomarker been discovered/detected in a reduced sample set of less than 50 in a laboratory setting?

Is a basic script ready and a working version created?

Have limited in vitro (with cells)/X vitro (with a tissue)/in vivo (in animal models) studies been performed?

Has validation of the basic prototype in a lab environment started?

Has the biomarker been detected in a bigger sample of that less than 100 in a laboratory setting?

Our clinical functionality is of the software validated in a controlled environment with at least partially representative data?

The proof of concept and the safety of the candidate drug demonstrated?

Has testing of representative prototype in a relevant patients/clinical environment started?

Is the biomarker being detected in a large independent or external source samples at greater than 1000?

Has alpha testing started? (In a controlled environment with representative data)

Is the R&D application ready to be submitted?

Have clinical studies with the final prototype started?

Is the diagnostic screening test developed and finalised?

Has beta testing started? (In a relevant environment)

Are phase 1 clinical trials completed?

Is submission for qualification of the device being prepared

Has a prospective validation of the biomarker in a real clinical context started what is the submission for the qualification of the test ready?

Is the submission for qualification of the software ready?

Are phase 2 clinical trials completed?

Has the device been approved by regulatory agencies?

Is the test approved by regulatory agencies as a screening/diagnostic test?

Has the software have been approved by regulatory agencies?

Are phase 3 clinical trials completed and the new drug application (NDA) has been approved?

Is the device being sold?

Is the test being sold?

Is the software being sold?

Is the drug being sold?