Resources for Food and Drug Administration (FDA)

Cancer test OK required by FDA

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Shares of cancer test developer EXACT Sciences Corp. tumbled yesterday, one day after disclosing the Food and Drug Administration said the company’s colon cancer test needs regulatory approval.

The biotechnology company saw its stock drop 22 percent, closing down $1.30 to $4.72 a share in heavy volume of 3.1 million shares on the Nasdaq Stock Market.

EXACT Sciences said Tuesday night the FDA believes the company’s PreGen-Plus product, which looks for genetic information in stool samples to determine if a person might have colon cancer, is a medical device which requires premarket approval or clearance.

Company officials, in a conference call yesterday with investors, said the FDA request came as a surprise, particularly since the test has been on the market since August 2003 under a so-called “homebrew” FDA exemption.

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