Sequenom
Encyclopedia
Sequenom is a manufacturer of DNA massarrays, based in San Diego, California, United States. The MassARRAY platform is used for SNP genotyping, methylation detection and quantitative gene expression analysis. Sequenom also manufactures clinical tests, such as SEQureDx, a noninvasive prenatal test formerly under development for Down syndrome
. In 2008, Sequenom largely reinvented itself from a genomics instrumentation provider to a genetic diagnostics company.
In 2009, Sequenom Center for Molecular Medicine (SCMM) was expected to launch the SEQureDx prenatal screening tests for Down syndrome and Rhesus D. However, subsequent investigation revealed significant flaws in the studies of the test's effectiveness. As a result, the board of directors of Sequenom fired CEO Harry Stylli, senior vice president of research and development Elizabeth Dragon and three other employees after a probe discovered that the company had failed to adequately supervise its Down syndrome test. CFO Paul Hawran also resigned. Board chairman Harry F. Hixson Jr. was named as the interim CEO and director Ronald M. Lindsay was appointed to replace Dragon. Dragon has since been charged by the Securities and Exchange Commission (SEC) because she "lied to the public about the accuracy of Sequenom's prenatal screening test for Down syndrome". Dragon, Elizabeth Alice died on February 26, 2011
In 2010, Sequenom paid $14 million to settle a class-action lawsuit by shareholders that arose from the mistakes in the development of the Down syndrome test. Also, Sequenom executives are under investigation by the SEC for insider trading for selling shares of Sequenom stock before announcement of problems with the test.
On September 1, 2011 Sequenom has entered into a cease-and-desist order with the US Securities and Exchange Commission.
On August 11, 2011 Sequenom Announces European Licensing Agreement With LifeCodexx.The companies have agreed to collaborate in the development and launch of a trisomy 21 laboratory developed test and other aneuploidies testing in Germany, Austria, Switzerland, and Liechtenstein, with the potential for additional launches in other countries.Under this initial five year licensing agreement, Sequenom has granted LifeCodexx licenses to key patent rights, including European Patent EP0994963B1 and pending application EP2183693A1, that enable the development and commercialization of a non-invasive aneuploidy test utilizing circulating cell free fetal DNA in maternal plasma.
On October 24, 2011 International Society of Prenatal Diagnostics (ISPD) issued a Rapid Response Statement in response to the launch of Sequenom non-invasive Trisomy 21 (MaterniT21) test.
On October 17, 2011 Sequenom Center for Molecular Medicine Announces Launch of MaterniT21 Noninvasive Prenatal Test for Down Syndrome
MaterniT21 Launch Presentation
Sequenom OncoCarta(OncoMap) identifies 396 unique "druggable" or "actionable" mutations in 33 cancer genes. In total, 417 mutations being identified.
MassARRAY Spectrometry Is More Sensitive than PreTect HPV-Proofer and Consensus PCR for Type-Specific Detection of High-Risk Oncogenic Human Papillomavirus Genotypes in Cervical Cancer.
Down syndrome
Down syndrome, or Down's syndrome, trisomy 21, is a chromosomal condition caused by the presence of all or part of an extra 21st chromosome. It is named after John Langdon Down, the British physician who described the syndrome in 1866. The condition was clinically described earlier in the 19th...
. In 2008, Sequenom largely reinvented itself from a genomics instrumentation provider to a genetic diagnostics company.
In 2009, Sequenom Center for Molecular Medicine (SCMM) was expected to launch the SEQureDx prenatal screening tests for Down syndrome and Rhesus D. However, subsequent investigation revealed significant flaws in the studies of the test's effectiveness. As a result, the board of directors of Sequenom fired CEO Harry Stylli, senior vice president of research and development Elizabeth Dragon and three other employees after a probe discovered that the company had failed to adequately supervise its Down syndrome test. CFO Paul Hawran also resigned. Board chairman Harry F. Hixson Jr. was named as the interim CEO and director Ronald M. Lindsay was appointed to replace Dragon. Dragon has since been charged by the Securities and Exchange Commission (SEC) because she "lied to the public about the accuracy of Sequenom's prenatal screening test for Down syndrome". Dragon, Elizabeth Alice died on February 26, 2011
In 2010, Sequenom paid $14 million to settle a class-action lawsuit by shareholders that arose from the mistakes in the development of the Down syndrome test. Also, Sequenom executives are under investigation by the SEC for insider trading for selling shares of Sequenom stock before announcement of problems with the test.
On September 1, 2011 Sequenom has entered into a cease-and-desist order with the US Securities and Exchange Commission.
MaterniT21 Noninvasive Prenatal Test for Down Syndrome
On August 4, 2011 Sequenom said it will call its new blood test for Down syndrome in pregnancy MaterniT21 when the product goes on sale in the United States.On August 11, 2011 Sequenom Announces European Licensing Agreement With LifeCodexx.The companies have agreed to collaborate in the development and launch of a trisomy 21 laboratory developed test and other aneuploidies testing in Germany, Austria, Switzerland, and Liechtenstein, with the potential for additional launches in other countries.Under this initial five year licensing agreement, Sequenom has granted LifeCodexx licenses to key patent rights, including European Patent EP0994963B1 and pending application EP2183693A1, that enable the development and commercialization of a non-invasive aneuploidy test utilizing circulating cell free fetal DNA in maternal plasma.
On October 24, 2011 International Society of Prenatal Diagnostics (ISPD) issued a Rapid Response Statement in response to the launch of Sequenom non-invasive Trisomy 21 (MaterniT21) test.
MaterniT21 Launch
On October 17, 2011 Sequenom announced that a clinical validation study leading to the introduction of the MaterniT21 LDT has been published in the journal Genetics in Medicine.On October 17, 2011 Sequenom Center for Molecular Medicine Announces Launch of MaterniT21 Noninvasive Prenatal Test for Down Syndrome
MaterniT21 Launch Presentation
MassARRAY Analyzer 4
Sequenom Oncomap Version 3 - "core" set interrogates ~450 mutations in 35 genes,"extended" set interrogates ~700 mutations in 113 genesSequenom OncoCarta(OncoMap) identifies 396 unique "druggable" or "actionable" mutations in 33 cancer genes. In total, 417 mutations being identified.
MassARRAY Spectrometry Is More Sensitive than PreTect HPV-Proofer and Consensus PCR for Type-Specific Detection of High-Risk Oncogenic Human Papillomavirus Genotypes in Cervical Cancer.