A Medical Device Daily

Sequenom (San Diego) said it has removed almost its entire top management team as a result of a scandal involving mishandling of research and critical data on its prenatal Down syndrome test.

The genetic analysis products maker's board said it fired president/CEO Harry Stylli and research chief Elizabeth Dragon and obtained the resignation of CFO Paul Hawran and one other unidentified officer.

Three other employees were also dismissed following completion of an independent investigation by a committee of independent directors.

In April, Sequenom delayed the launch of the SEQureDx test, citing mishandling of research and development test data by employees and said it had initiated an independent investigation into the matter (Medical Device Daily, May 4, 2009).

"The company failed to put in place adequate protocols and controls for the conduct of studies in the Trisomy 21 (Down syndrome) program," Sequenom said in a statement.

"Certain of the company's employees also failed to provide adequate supervision," the statement said, adding that, as a result, test data and clinical results included "inadequately substantiated claims, inconsistencies and errors."

Board chairman Harry Hixson has been appointed as interim CEO, the company said.