The more you read on the topic of approval for CDx the more complex it gets in regards to the FDA approval. A couple of articles, all case studies are on oncology drugs & tests which have been approved though & warning, some heavy reading:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5355969/
https://higherlogicdownload.s3.amazonaws.com/AMSTAT/a01447ce-1e24-42ee-978a-5042a9f1e423/UploadedImages/Greg_Campbell%20ASA%20Biomarker%20Symposium%20P-T%205-17.pdf
PromarkerD test can be done in CLIA approved Labs in the USA prior to regulatory approval & types of approvals are discussed in the article above, including CLIA.
PIQ ANN explaining this in regards to CLIA approved laboratories (6400 in the USA).
https://www.proteomics.com.au/wp-content/uploads/190729-ASX-release_PromarkerD-secures-TGA-software-approval-Indonesian-patent600.pdf
GLTAH
Ann: Proteomics raises $3m in heavily oversubscribed Placement, page-30
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