Exact Sciences sees resolution of FDA's regulatory concerns over Pre-Gen-Plus

By Jennifer Lanning Drey

Eugene, Ore., June 12 - Exact Sciences Corp. believes it has satisfactorily responded to questions raised by the Food and Drug Administration regarding the regulatory status of Pre-Gen-Plus, its homebrewed colorectal cancer screening kit, according to Don Hardison, president and chief executive officer of the company.

"I now believe we have obtained the clarity we need to productively move forward," said Hardison in a company conference call held Monday.

Exact said homebrew tests have historically been exempt from the pre-market clearance or approval requirements of the FDA, in its 10-Q filing with the Securities and Exchange Commission made on April 27.

However, Laboratory Corp. of America, the exclusive licensee of the patent for Pre-Gen-Plus, received a letter from the FDA in January indicating that Pre-Gen-Plus is subject to FDA regulation as a medical device.

The agency also indicated that the device could not be commercially distributed without an appropriate pre-market determination from the FDA, according the filing.

Since receiving the letter, Exact said that along with LabCorp, it had participated in numerous conversations with the FDA regarding the regulatory status of Pre-Gen-Plus.

In addition, Exact and LabCorp have taken steps toward finding a solution with the FDA, Hardison said.

In one such step, LabCorp told the agency that by the end of the year, it would eliminate the use of Effipure, another DNA screening technology that was the primary focus of the FDA's correspondence in January, a communication that also notified the company of regulatory issues involving Pre-Gen-Plus.

LabCorp is currently evaluating an alternative to Effipure that would meet FDA guidelines, Hardison said.

Following discussions with the FDA, Exact has also removed all promotional references to Pre-Gen-Plus from its Web site and plans to refocus its sales efforts away from direct marketing to physicians, he said.

Exact has also confirmed its intention to meet with the FDA to discuss the regulatory approval process for an in vitro colorectal cancer diagnostic kit that it currently has in development, Hardison said.

'Realist' approach to regulations

Hardison indicated that Exact would move ahead cautiously as it works to incorporate a new technology that has demonstrated an 88% sensitivity rate into its test kits.

"While we are pleased with where things stand with the FDA at this point, we're also realists. We fully understand that regulation in the area of homebrewed tests continues to evolve and could potentially create new regulatory barriers for any laboratory testing company with a homebrewed test on the market," Hardison said during the call.

Moving forward, the company will focus on combining the new technology with both the homebrew screening kit and the in vitro diagnostic kit in development, Hardison said.

LabCorp will have the opportunity to develop the new homebrewed assay incorporating the new technology, he said.

"Based on discussions with LabCorp, I believe they are very excited about this new opportunity and are interested in getting a new homebrewed test to market as quickly as possible in a way that fully complies with FDA requirements," Hardison said.

Exact will develop and sell the in vitro diagnostic kit. The company expects to have a meeting to discuss the regulatory pathway for the product in the near term, he said.

Hardison said he expects FDA-approved labeling to offer the company greater flexibility for market penetration moving forward.

Exact Sciences, based in Marlborough, Mass., uses applied genomics to develop screening technologies for use in cancer detection.

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