Wednesday, June 25, 2008

Calif. to Knome: Stop genetic testing

By Mass High Tech Staff

The state of California has issued Cambridge startup Knome Inc. an order to stop offering its genetic testing services to residents in the Golden State, according to state documents.

In a June 9 letter from the California Department of Public Health, the state informed Knome that the company had not obtained a laboratory license there to offer its services, nor does the company comply with a California law that requires physicians to order genetic tests for patients, according to a copy of the letter.

Knome, which provides whole-genome sequencing to individuals for $350,000, is among 13 genetic testing companies around the United States that received such letters from California health officials. The state of New York is also said to be cracking down on companies that offer genome testing to residents without licenses and doctor’s orders. It’s unclear whether Knome has received notice from New York authorities.

Jorge Conde, president and CEO of Knome, issued the a statement about the California order Wednesday, saying the company had not responded to the letter but intended to work with California health officials to address their concerns. The letter states that Knome had until Monday, June 23, to submit a plan, in which the gene-testing company must detail how it intends to comply with California laws, or face certain civil and criminal penalties.

Knome, founded in 2007, features highly respected scientists among its advisers, including Harvard Medical School professor of genetics George Church and MIT microbiology professor Anthony Sinskey, according to its website.