Profile: Sequenom Inc (SQNM.O)

Sequenom, Inc. (Sequenom), incorporated in 1994, is a diagnostic testing and genetics analysis company. The Company is focused on providing products, services, diagnostic testing, applications and genetic analysis products that translate the results of genomic science into solutions for biomedical research, translational research, molecular medicine applications, and agricultural, livestock and other areas of research. Its development and commercialization efforts in various diagnostic areas include non-invasive prenatal diagnostics, oncology, infectious diseases and other disorders. The Company is researching, developing and pursuing the commercialization of various non-invasive molecular diagnostic tests for prenatal genetic disorders and diseases, oncology, infectious diseases, and other diseases and disorders. On November 14, 2008, it completed the asset acquisition of the Center for Molecular Medicine, LLC (CMM). On November 17, 2008, the Company acquired Grand Rapids, a center for molecular medicine.

Molecular Diagnostics

The Company has branded its diagnostic technology for prenatal diagnostics, under the name SEQureDx. Sequenom efforts in molecular diagnostics are focused on non-invasive diagnostics using its MassARRAY system. It is primarily focused on developing and commercializing prenatal screening and diagnostic tests using its non-invasive, circulating cell-free fetal (ccff) nucleic acid-based assay technology. This technology is non-invasive to the womb using a simple maternal blood draw for prenatal diagnosis in order to provide information about the fetus early in pregnancy. The Company’s planned screening and diagnostic tests in areas of women’s health, oncology and infectious disease are also non-invasive.

Prenatal Diagnostics

Non-invasive prenatal diagnostic tests based on Sequenom’s foundational fetal nucleic acid analysis are initially being developed on its MassARRAY platform for chromosomal aneuploidies, including Trisomy 21 (Down syndrome), Trisomy 18 (Edwards syndrome), and Trisomy 13 (Patau syndrome), Rhesus D genotyping and gender determination for sex-linked disorders. Through the Clinical Laboratory Improvement Amendments (CLIA) laboratory, the Sequenom Center for Molecular Medicine (SCMM), located in Grand Rapids, Michigan, laboratory developed tests (LDTs) will be developed, validated and commercialized.

In September 2008, the Company announced results from its Trisomy 21 prenatal test studies using the RNA-based ccff SEQureDx technology. Sequenom reported that data from blinded studies involving 399 clinical samples collected prospectively showed that its test for Down syndrome identified 100% of all Down syndrome samples without any false-positive or false-negative outcomes. In January 2009, it announced further results from additional Trisomy 21 prenatal test studies using RNA-based ccff SEQureDX technology. It presented data for 459 new samples from prospective blinded studies, bringing the total number of samples studied to 858.

Genetic Analysis

The Company’s MassARRAY system, consisting of hardware, software applications, consumable chips and reagents, is a nucleic acid analysis platform that measures genetic target material and variations. Sequenom’s customers include clinical research laboratories, bio-agriculture, bio-technology and pharmaceutical companies, academic institutions, and various government agencies worldwide. Its MassARRAY system provides results for a range of deoxyribonucleic Acid (DNA)/ ribonucleic acid (RNA) analysis applications, including single nucleotide polymorphism (SNP), genotyping detection of mutations, analysis of copy number variants and other structural genome variations. In addition, the system provides quantitative gene expression analysis, quantitative methylation marker analysis, comparative sequence analysis of haploid organisms, SNP discovery, and oligonucleotide quality control. During the year ended December 31, 2008, the Company’s genetics analysis business product offerings and developments included iSEQ Comparative Sequence Analysis, Copy Number Variation (CNV), Epigenomics Applications and Panels, OncoCarta Mutation Panel and Closed Tube Assay.