The Food and Drug Administration, in a report released on the eve of a congressional hearing Tuesday, said that certain laboratory tests “may have caused or have caused” actual harm to patients by producing erroneous results.
At issue are so-called lab-developed tests, or LDTs, which are produced and performed within a single hospital or corporate laboratory. Such tests are often done on tissue samples sent in from outside doctors and hospitals. They are distinct from standard diagnostic equipment and products that are sold to doctors’ offices, hospitals or other labs.
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