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pgx testing labs
PGx Testing Labs Concerned by FDA’s Statements, Actions
This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) ha…
PGx Labs Concerned by FDA’s Statements, Actions
CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to ce…
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Volume XXVIII, No. 13 – September 27, 2021
This issue highlights the young and upcoming IVD firms that are creating a new class of such companies, dedicated to point of care and near-patient technologies. Also, artificial intelligence has made its first breakthrough into clinical care in digital pathology.
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