Sequenom

Sequenom, Inc. was a San Diego-based molecular-diagnostics and biotechnology company whose best-known contribution was the development and commercialization of noninvasive prenatal testing using cell-free fetal DNA circulating in maternal blood. Through its wholly owned Sequenom Center for Molecular Medicine subsidiary, the company offered laboratory-developed tests intended to assess the risk of fetal chromosomal abnormalities without the procedural risks associated with amniocentesis or chorionic-villus sampling. The company’s central prenatal offering was MaterniT21, later marketed as MaterniT21 PLUS. The test analyzed fragments of fetal genetic material in a pregnant patient’s blood to identify an increased likelihood of trisomy 21, the chromosomal condition associated with Down syndrome. The expanded MaterniT21 PLUS panel also assessed trisomy 18 and trisomy 13. Sequenom additionally developed or commercialized testing related to fetal Rhesus D status and other clinical molecular-genetics applications. Sequenom’s business was broader than prenatal diagnostics. It developed enabling molecular technologies and operated a biosciences business associated with genetic analysis, mass spectrometry, research-use assays, oncology mutation profiling, pharmacogenomics, and molecular testing. Its MassARRAY platform supported genotyping and mutation analysis, while products such as OncoMap, OncoCarta, and the iPLEX ADME PGx Panel were aimed at research and clinical-development applications rather than direct-to-consumer testing. Sequenom became a public company through an initial public offering in 2000. Its development of noninvasive prenatal testing gave it a prominent position in a rapidly expanding diagnostics field, but the company also experienced a serious credibility crisis in 2009 after an investigation found problems in the development and oversight of an earlier prenatal screening program known as SEQureDx. The episode led to executive departures, regulatory action, litigation, and a shareholder settlement. Sequenom subsequently repositioned its prenatal business around the validated MaterniT21 platform. The company was also involved in extensive patent litigation concerning the use of cell-free fetal DNA for prenatal diagnosis. Its disputes with Ariosa Diagnostics, Natera, Verinata Health, and Stanford University reflected the strategic importance of intellectual-property rights in the emerging noninvasive prenatal-testing market. Courts ultimately held the relevant Sequenom patent invalid in the Ariosa litigation, and the Federal Circuit affirmed that result in 2015. In 2014, Sequenom sold its biosciences unit to Agena Bioscience for up to $35.8 million. In July 2016, Labcorp announced an agreement to acquire Sequenom for $2.40 per outstanding share. The transaction closed in September 2016, ending Sequenom’s existence as an independent publicly traded company and integrating its diagnostics capabilities into Labcorp’s broader laboratory network.

Sequenom emerged as a molecular-diagnostics and biotechnology company in San Diego, California, building businesses around sensitive genetic analysis and molecular technologies. It completed an initial public offering in 2000 and developed a portfolio spanning research-use instrumentation, genotyping assays, oncology mutation analysis, pharmacogenomics, and clinical laboratory testing. A major early strategic focus was prenatal genetic testing. Sequenom’s subsidiary, Sequenom Center for Molecular Medicine, worked on SEQureDx tests intended to screen for Down syndrome and fetal Rhesus D status. In 2009, an internal investigation found substantial problems in the research and oversight supporting the Down syndrome test. The company dismissed chief executive Harry Stylli, research-and-development executive Elizabeth Dragon, and other employees; chief financial officer Paul Hawran also resigned. Harry F. Hixson Jr. became interim chief executive. The episode led to Securities and Exchange Commission proceedings, a shareholder class-action settlement, and lasting reputational damage. Sequenom subsequently concentrated on a new generation of noninvasive prenatal testing based on cell-free fetal DNA in maternal blood. In 2011, it announced the MaterniT21 name and launched MaterniT21 as a laboratory-developed test for Down syndrome. The test was later expanded as MaterniT21 PLUS to include trisomy 18 and trisomy 13. Sequenom also offered the SensiGene RHD Fetal RHD Genotyping Test. MaterniT21’s noninvasive format positioned it as an alternative screening approach to invasive diagnostic procedures, although positive screening results still required appropriate clinical interpretation and, where indicated, diagnostic confirmation. The prenatal-testing business developed alongside an active intellectual-property strategy. Sequenom brought patent actions against Ariosa Diagnostics and Natera in 2012 and acquired pending fetal-DNA patent applications from Helicos Biosciences. It also faced patent claims involving Verinata Health and Stanford University concerning the so-called Quake patents. The Ariosa litigation ultimately became especially significant: the district court held that the relevant claims were invalid because they covered a natural phenomenon, and the Federal Circuit affirmed the judgment in June 2015. The Federal Circuit later declined a request for rehearing en banc. Outside clinical prenatal testing, Sequenom maintained technology and product interests in mass spectrometry-based genotyping. The MassARRAY platform supported mutation detection and genotyping, while OncoMap and OncoCarta addressed research into actionable or druggable mutations in cancer-related genes. The iPLEX ADME PGx Panel was designed for research into genetic variants affecting drug disposition. In 2014, Sequenom sold its biosciences unit to Agena Bioscience, narrowing its strategic emphasis toward diagnostics. In 2016, Labcorp agreed to acquire Sequenom for $2.40 per outstanding share. The transaction closed in September of that year. Sequenom therefore ceased operating as an independent public company, while its prenatal-testing capabilities and related assets became part of Labcorp’s diagnostics business.

• 2016

  Acquired by Labcorp

  [1]Sequenomen.wikipedia.org

  Labcorp completed its acquisition of Sequenom, ending the company’s independent existence.

• 2015

  Key patent invalidity ruling affirmed

  [1]Sequenomen.wikipedia.org

  The Federal Circuit affirmed the invalidity of the patent claims at issue in the Ariosa litigation.

• 2014

  Biosciences unit divested

  [1]Sequenomen.wikipedia.org

  The company sold its biosciences unit to Agena Bioscience.

• 2012

  Patent disputes expand

  [1]Sequenomen.wikipedia.org

  Sequenom initiated major patent litigation involving Ariosa Diagnostics and Natera and acquired pending fetal-DNA patent applications from Helicos.

• 2011

  MaterniT21 introduced

  [1]Sequenomen.wikipedia.org

  Sequenom announced and launched MaterniT21, a noninvasive prenatal screening test based on cell-free fetal DNA.

• 2009

  SEQureDx investigation and executive changes

  [1]Sequenomen.wikipedia.org

  An investigation identified serious problems in the development and supervision of a Down syndrome screening test, prompting multiple executive departures.

• 2000

  Initial public offering

  [1]Sequenomen.wikipedia.org

  Sequenom became a publicly traded company through an initial public offering.

A pioneer in noninvasive prenatal testing and a provider of molecular-genetic analysis technologies.

• Noninvasive prenatal screening · 2011

  MaterniT21 PLUS

  A laboratory-developed prenatal screening test that analyzes cell-free DNA in maternal blood. The test was designed to identify elevated risk for trisomy 21, trisomy 18, and trisomy 13. Its principal differentiator was avoiding the procedural risks of invasive sampling methods, although it remained a screening test rather than a definitive diagnostic procedure.

• Noninvasive prenatal screening · 2011

  MaterniT21

  Sequenom’s original branded noninvasive prenatal test for Down syndrome. It used fetal genetic material circulating in maternal plasma and became the foundation for the later MaterniT21 PLUS offering.

• Prenatal molecular testing

  SensiGene RHD Fetal RHD Genotyping Test

  A prenatal molecular test intended to determine fetal Rhesus D genotype from maternal blood. It was part of Sequenom’s broader portfolio of clinical molecular-genetics tests offered through its laboratory subsidiary.

• Genetic analysis instrumentation

  MassARRAY Analyzer 4

  A mass-spectrometry-based platform used for molecular genotyping and mutation analysis. Sequenom’s MassARRAY business supported research and laboratory workflows involving single-nucleotide variants, insertions and deletions, copy-number changes, and other genetic markers.

• Oncology mutation profiling

  OncoMap and OncoCarta

  Research-oriented mutation panels for identifying potentially actionable alterations in cancer-related genes. The product family included core and extended configurations covering mutations across dozens of genes and was intended to support oncology research and therapeutic investigation.

• Pharmacogenomics · 2011

  iPLEX ADME PGx Panel

  A research-use panel for studying polymorphisms associated with drug absorption, distribution, metabolism, and excretion. It included predesigned assays for single-nucleotide polymorphisms, insertions and deletions, and copy-number variation, with software used to evaluate resulting haplotypes.

• 2011

  SEC cease-and-desist order

  Sequenom entered into a cease-and-desist order with the Securities and Exchange Commission following the prenatal-test controversy.

  Source

• 2010

  Shareholder litigation and SEC investigation

  Sequenom paid $14 million to settle a shareholder class-action lawsuit arising from problems in the Down syndrome test’s development. Company executives were also investigated in connection with alleged insider trading before the test problems became public.

  Source

• 2009

  SEQureDx prenatal-test controversy

  An investigation found serious flaws in studies supporting the effectiveness of Sequenom’s SEQureDx prenatal screening program. The findings led to executive dismissals and resignations, regulatory scrutiny, and a major loss of confidence in the company’s oversight of prenatal testing.

  Source

Read more

• 2011MaterniT21 launch

  United States

  Sequenom introduced MaterniT21 as a noninvasive prenatal screening option based on cell-free fetal DNA in maternal blood, positioning the test as an alternative to risk-bearing invasive sampling for aneuploidy screening.

  Outcome. The product became the company’s flagship prenatal-testing brand and was later expanded as MaterniT21 PLUS.

  Source
• 2011LifeCodexx European licensing collaboration

  Germany · Austria · Switzerland · Liechtenstein

  Sequenom licensed relevant patent rights to LifeCodexx and agreed to collaborate on development and commercialization of noninvasive trisomy testing in selected European markets.

  Outcome. The agreement extended Sequenom’s prenatal-testing strategy beyond the United States.

  Source

• 2016

  Agree to acquisition by LabcorpM&A

  Background

  Sequenom’s prenatal diagnostics capabilities were strategically relevant to a large laboratory-services company seeking to expand molecular testing.

  Action taken

  Labcorp agreed to acquire Sequenom for $2.40 per outstanding share.

  Aftermath

  The acquisition closed in September 2016 and Sequenom ceased to operate as an independent public company.

  Per-share acquisition consideration. $2.40 per outstanding share (2016)

  Source

• 2014

  Divest the biosciences unitStrategy

  Background

  Sequenom operated both a clinical diagnostics business and a broader biosciences technology business.

  Action taken

  The company sold its biosciences unit to Agena Bioscience.

  Aftermath

  The divestiture narrowed Sequenom’s portfolio and placed greater strategic emphasis on clinical and prenatal diagnostics.

  Maximum transaction consideration. $35.8 million (2014)

  Source

• 2011

  Launch MaterniT21Product launch

  Background

  Following the collapse of confidence in the earlier SEQureDx program, Sequenom needed a clinically supported prenatal-testing platform.

  Action taken

  The company launched MaterniT21 as a laboratory-developed noninvasive prenatal screening test based on cell-free fetal DNA.

  Aftermath

  MaterniT21 became Sequenom’s defining product and was later expanded to the MaterniT21 PLUS panel.

  • Ariosa Diagnostics — Ariosa was among the companies competing in the emerging noninvasive prenatal-testing market and later became involved in patent litigation with Sequenom.
  • Natera — Natera competed in noninvasive prenatal testing and was named in Sequenom patent litigation.

  Source

1. 1Sequenomen.wikipedia.org