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FDA Warns ParagonDx that ASR Probes Require Premarket Approval

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) - The US Food and Drug Administration has sent a letter to ParagonDx warning that four of its analyte specific reagent probes are devices that require premarket approval from the agency.

According to the letter, the company's ASR probes for gauging the presence of CYP2C9*2, CYP2C9*3, VKORC1 1173, VKORC1 3730 variants "are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body."

The four variants are commonly measured in genetic tests to determine sensitivity to the blood thinner warfarin.

The letter, sent by the FDA's Office of In Vitro Diagnostics and dated March 18, was issued following an inspection of Paragon's facilities in Morrisville, NC, in August. It was posted on the FDA website this week.

The FDA warned the firm that the probes "do not meet the definition of an ASR," which it defines as "antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended to use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens."

Most ASRs are Class I devices that don't require FDA approval or clearance but are also prohibited from being marketed with claims about analytical or clinical performance.

"Your devices include several probes that must be used together to detect different genotypes rather than 'an individual chemical substance or ligand,'" the agency said in its letter.

ParagonDx has fifteen working days from the date it received the letter to notify the FDA of "specific steps" it has taken to correct the violation.

A more comprehensive version of this article appears in today's issue of Pharmacogenomics Reporter.

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