Skip to main content
Premium Trial:

Request an Annual Quote

Sequenom Avoids Fine from SEC, Enters Cease-and-Desist Order

NEW YORK (GenomeWeb News) – Sequenom today disclosed that it has entered into a cease-and-desist order with the US Securities and Exchange Commission related to previous public statements regarding its trisomy 21 test, but it will not have to pay any monetary penalties to the commission.

The cease-and-desist order specifically applies to public statements the firm had made during the period between January 2008 and June 2009 related to development of its trisomy 21 molecular test. Sequenom has agreed "not to commit or to cause any future violations of Sections 10(b) and 13(a) of the Exchange Act," and rules under those sections, it said in a filing with the SEC. Section 10(b) prohibits fraud, manipulation, and insider trading, while Section 13(a) covers rules regarding the filing of periodic reports with the SEC.

The SEC said in July 2009 that it had opened an investigation of the firm following its announcement during the preceding April that employees had mishandled R&D test data for the test.

A subsequent investigation by Sequenom's board of directors led to the dismissal of President and CEO Harry Stylli and Senior VP of R&D Elizabeth Dragon, among others, from the firm in September 2009.

With new management at the helm, Sequenom has since continued development of the sequencing-based test, now called MaterniT21. During its second-quarter conference call early last month Chairman and CEO Harry Hixson said the firm still intends to launch a T21 laboratory developed test following the publication of clinical data on the test, which is expected in late 2011 or early 2012. He added that a manuscript has been submitted to journal but has not yet been accepted.

The Scan

Drug Response Variants May Be Distinct in Somatic, Germline Samples

Based on variants from across 21 drug response genes, researchers in The Pharmacogenomics Journal suspect that tumor-only DNA sequences may miss drug response clues found in the germline.

Breast Cancer Risk Gene Candidates Found by Multi-Ancestry Low-Frequency Variant Analysis

Researchers narrowed in on new and known risk gene candidates with variant profiles for almost 83,500 individuals with breast cancer and 59,199 unaffected controls in Genome Medicine.

Health-Related Quality of Life Gets Boost After Microbiome-Based Treatment for Recurrent C. Diff

A secondary analysis of Phase 3 clinical trial data in JAMA Network Open suggests an investigational oral microbiome-based drug may lead to enhanced quality of life measures.

Study Follows Consequences of Early Confirmatory Trials for Accelerated Approval Indications

Time to traditional approval or withdrawal was shorter when confirmatory trials started prior to accelerated approval, though overall regulatory outcomes remained similar, a JAMA study finds.