HiFi DNA Tech

Healthcare Debate Gets Federal Court Hearing Dec. 11; MD Claims FDA's HPV Action Costs Extra $10B and Extra Worry for Women

Published in Drug Week, November 27th, 2009

The FDA will be held accountable during oral arguments Dec. 11 in federal court for its "inappropriate classification of a virus DNA-replicating device as a cancer test." The misclassification costs women extra worry and society at least $10 billion a year, according to HiFi DNA Tech, a Connecticut-based leader in DNA-based testing procedures.

HiFi DNA Tech has appealed to the U.S. Court of Appeals for the Second Circuit in Manhattan, asking the court to reverse the FDA's refusal to down-classify a human papillomarvirus (HPV) DNA replication device from a class III cancer test category to a class II virology device category or, in the alternative, remand the case to the...

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Source: Drug Week (2009-11-27)

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