NEW YORK (GenomeWeb News) — The US Food and Drug Administration has sent a letter to Qiagen warning it that certain of its molecular diagnostics currently sold in the US do not have regulatory approval.
In an Oct. 2 letter to Qiagen CEO Peer Schatz, the FDA said six diagnostic products Qiagen developed are improperly marketed and require regulatory review by the agency. On its we site, Qiagen stresses that the products — tests for herpes virus, lime disease, parvovirus, Chlamydia, and malaria — are designed for use in CLIA labs and therefore do not require FDA oversight.
The FDA, on the other hand, claims that because the tests are packaged with instructions they are subject to agency review.
Products affected include Artus CMV PCR, C. Trachomatis PCR, C. Trachomatis Plus PCR, Parvo B19 PCR, Borrelia PCR, and Malaria PCR analyte specific reagents.
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