Road to Rome: Commercialization of Point-of-Care Devices and Academic Research

Point-of-Care (POC) Testing is also referred to as decentralized or bedside testing. According to the Clinical Laboratory Improvement Amendment (CLIA) criteria, POC testing is generally divided into waived and non-waived testing categories based on their operational complexity [1]. Any non-clinical test with an approval from the US Food and Drug Administration (FDA) which employs very simple and accurate methodologies such that probability of erroneous results is either negligible or presents no reasonable risk to the patients upon being used inappropriately is considered in CLIA-waived category. Such tests are enlisted on CDC website and are constantly being updated. The Nonwaived testing category includes moderately to highly complex tests which require certain degree of scientific and technical knowledge and training to perform them accurately. Operational steps in such tests are either easily controlled with certain degree of automation or may have to be strictly controlled with appropriate monitoring. Extensive analytical interpretations and judgements made by highly trained and qualified personnel is the key to CLIA non-waived category