Verinata claims that Sequenom's lawyers sent it a letter in 2010 alleging that "'the practice of non-invasive prenatal diagnostics, including diagnosis of the Down Syndrome and other genetic disorders, using cell-free nucleic acids in a sample of maternal blood infringes' the '540 patent, as well as the claims of a pending United States Patent Application.

held that the '540 patent was invalid because it claimed a natural phenomenon, the presence of cell-free fetal DNA fragments in maternal blood.

[16] 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.

Board chairman Harry F. Hixson Jr. was named 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".

[18][19] In 2010, Sequenom paid $14 million to settle a shareholder class-action lawsuit that arose from the errors in the development of the Down syndrome test.

[24] The primary advantage of MaterniT21 PLUS over the other major high accuracy tests for Down syndrome, Amniocentesis and Chorionic villus sampling, is that MaterniT21 PLUS is noninvasive.

[31] On October 17, 2011 Sequenom announced that a clinical validation study leading to the introduction of the MaterniT21 LDT had been published in the journal Genetics in Medicine.

[34][35][36][37] 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.

This Research Use Only (RUO) panel contains a set of pre-designed single nucleotide polymorphisms (SNP), insertions and deletions (INDELS) and copy number variation (CNV) assays for use in the investigation of variants with demonstrated relevance to drug metabolism.

After detection on the MassARRAY (RUO) system, a proprietary software solution is then used to score and qualify polymorphisms to create a unique haplotype report.