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Sequenom Reports Fourth Quarter and Full Year 2010 Financial Results
Date:3/8/2011

lly raised gross proceeds of approximately $148 million in two financings to fund ongoing operations.

Genetic Analysis Segment – In April 2010 the company launched its next generation MassARRAY analyzer for the research use only community. The business segment continues to grow and realized an approximate 19% year-over-year growth. During 2010 the company shipped 51 MassARRAY analyzers.

Regulatory – In October 2010 the company submitted a pre-IDE package to the FDA for its SEQureDx™ Trisomy 21 test.

Sequenom CMM – During 2010 Sequenom CMM achieved a number of important milestones:

  • Introduced the SensiGene® Fetal RHD Genotyping LDT in February
  • Completed the T21 'locked-assay' study in September
  • Built, equipped and licensed  our CLIA laboratory, located in San Diego in October to support our planned SensiGene Trisomy 21 LDT launch
  • Initiated SensiGene T21 LDT clinical validation study in December
  • Completed the SensiGene age related macular degeneration (AMD)LDT in silico validation study in December

  • 2011 ProgramsTrisomy 21 Program Update – In December 2010 Sequenom CMM initiated its clinical validation study for the Trisomy 21 LDT. The company expects that Sequenom CMM will complete the study by the middle of 2011 and a manuscript reporting the results will be submitted shortly thereafter.  We anticipate publication of this key study by the end of 2011 or early 2012.

    The company initiated discussion with the FDA in January 2011 regarding the necessary preclinical and clinical studies required to support a premarket approval application to the FDA for an in vitro diagnostic device for trisomy 21. The company anticipates continuing a constructive dialog with the FDA over the coming months.

    In March 2011, results from the Trisomy 21 "locked-assay" study were published in the American Journal of Obste
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    SOURCE Sequenom, Inc.
    Copyright©2010 PR Newswire.
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