Monday, Sequenom Inc. (SQNM) said following the company's announcement on September 28, regarding the completion of the independent investigation related to the test data and results of its noninvasive prenatal test for Down syndrome, representatives of the Nasdaq and the office of the U.S. Attorney for the Southern District of California separately contacted the company to inquire about the announcement.
In addition, the San Diego, California-based life sciences company also announced that it met with representatives of the U.S. Attorney and the Federal Bureau of Investigation, and the Enforcement Staff of the Securities and Exchange Commission in connection with their investigations. The company announced its intention to cooperate fully with Nasdaq and with the U.S. Attorney.
On April 30, Sequenom said it would delay the launch of SEQureDx Down syndrome test due to the discovery by company officials of employee mishandling of R&D test data and results. In the after-hours, on April 30, the company's shares plunged $10.22 or 68.54% to $4.69.
On September 28, Sequenom said that it has completed an independent investigation related to the test data and results of its noninvasive prenatal test for Trisomy 21, or Downs syndrome by a special committee of independent directors and noticed 'inadequately substantiated claims, inconsistencies and errors'.
Sequenom said that based on the special committee's work and recommendations, the independent members of the company's board of directors have concluded that the company failed to put in place adequate protocols and controls for the conduct of studies in the Trisomy 21 program.
Also, certain employees have failed to provide adequate supervision. In the absence of such protocols, controls and supervision, the test data and results of Trisomy 21 program included inadequately substantiated claims, inconsistencies and errors, the company noted.
In connection with the probe, the company fired its chief executive officer, Harry Stylli, and senior vice president of research and development, Elizabeth Dragon, and three other employees. The company has also obtained the resignation of its chief financial officer, Paul Hawran, and one other officer.
The company reiterated that it is no longer relying on, and the public should no longer rely on, any of the previously announced test data and results for Trisomy 21.
The company noted that the special committee's investigation has raised serious concerns, which has resulted in a loss of confidence in the personnel involved. Meanwhile each of these officers and employees has denied wrongdoing, the company said.
Sequenom said it has started implementing a number of remedial measures. However, the company added that presently it is not possible to provide guidance on the timetable for the completion of research and development or for the potential commercialization of its Trisomy 21 test. Sequenom said it is continuing its research and development program for this test.
SQNM declined $0.06 or 1.95% and closed Monday's regular trading at $3.02. After hours, SQNM declined further $0.12 or 3.97% and traded at $2.90.
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