Feds’ Sequenom Probe Breaks Into the Open, Life Technologies Moves Into Synthetic Biology, DexCom Agrees to Re-Label Its Medical Devices, & More San Diego Life Sciences News
The big news came with a guilty plea by Sequenom’s former R&D chief, but it’s just the beginning. In pleading guilty, Elizabeth Dragon agreed to cooperate with a continuing criminal investigation of wrongdoing in the company’s development of a prenatal diagnostic test for Down syndrome. Our weekly wrap-up begins here.
—The former chief of research and development at San Diego’s Sequenom (NASDAQ: SQNM) pleaded guilty yesterday to conspiring to commit securities fraud. Elizabeth A. Dragon, who joined Sequenom in 2006 after 16 years at Roche Molecular Diagnostics, admitted in federal court that she had lied to investors about the sensitivity and accuracy of a prenatal genetic test the company was developing for Down syndrome. Dragon, who has agreed to cooperate with a continuing criminal investigation, also settled a civil suit filed yesterday by the Securities and Exchange Commission.
—San Diego’s DexCom (NASDAQ: DXCM) says it will comply with changes sought by the FDA in the way it labels certain biomedical devices used to monitor blood sugar levels. In a warning letter sent to the company, the FDA says DexCom should have disclosed that its sensor wires sometimes fracture, leaving wire splinters under the skin of some users.
—James Sweeney, who started CardioNet (NASDAQ: BEAT) in San Diego and led its $425 million IPO in 2008, says his advice to startup CEOs about initial public offerings is “to avoid going public at all costs.” Sweeney, who now heads San Diego’s PatientSafe Solutions, talked about IPOs, reverse mergers, and other corporate exits during a meeting of the San Diego Venture Group.
—In a small step for gene therapy, San Diego-based Celladon says its gene therapy treatment for healing patients with advanced heart failure didn’t appear to cause any serious side effects and was more effective than a placebo in a study with 39 patients. The biotech hasn’t yet disclosed exactly how effective its treatment is.
—Carlsbad, CA-based Life Technologies (NASDAQ: LIFE) made an undisclosed equity investment in San Diego’s Synthetic Genomics, the startup co-founded by genomics pioneer J. Craig Venter. Life Technologies makes many of the laboratory instruments and materials that Synthetic Genomics and other biotechs use to sequence the genomes of different organisms.
—Life Technologies also disclosed that it has acquired a 74 percent ownership stake in Germany’s GeneArt, one of five small companies around the world that specialize in synthesizing custom-ordered genes for use in biomedical research.
—Luke profiled Blue Heron Biotechnology, which is the Bothell, WA, biotech that Craig Venter recently turned to in making the first bacterial cell with an entirely synthetic genome. Like GeneArt, Blue Heron is among the five small biotechs that specialize in synthesizing custom-ordered genes for use in biomedical research.