that do not verify the text . please help improve this article by checking for citation inaccuracies . october 2011 learn how and when to remove this template message sequenom type public company traded as nyse sqnm industry biotechnology headquarters san diego ca usa key people ceo dirk van den boom products maternit21 plus maternit genome visibilit heredit cf heredit universal nextview sensigene rhd services non invasive prenatal testing nipt carrier screening website official site sequenom nasdaq sqnm is an american company based in san diego california . it develops enabling molecular technologies and highly sensitive laboratory genetic tests for nipt and carrier screening . sequenom s wholly owned subsidiarity sequenom center for molecular medicine scmm offers multiple clinical molecular genetics tests to patients including maternit21 plus a noninvasive prenatal test for trisomy 21 trisomy 18 and trisomy 13 heredit cf cystic fibrosis screening test and the sensigene rhd fetal rhd genotyping test . in june 2014 the company sold its biosciences unit to agena bioscience for up to 35.8 million . 1 in july 2016 it was announced that diagnostic and testing giant labcorp will acquire sequenom paying 2.40 for every outstanding share of sequenom stock . the sale has been approved by the board of directors but still needs to be approved by shareholders . 2 contents 1 competition 2 patent litigation 3 sequredx scandal 4 maternit21 plus 4.1 history 5 massarray analyzer 4 6 iplex adme pgx panel on massarray system 7 references 8 external links competition edit companies also offering non invasive prenatal genetic testing include ariosa 3 ravgen 4 illumina verinata health 5 and natera the panorama prenatal test . 6 other companies and universities that are working towards developing non invasive prenatal testing include stanford university . 7 patent litigation edit in january 2012 sequenom entered a patent battle with competing companies ariosa and natera accusing them of infringing the 540 patent us 6258540 . 8 the cases are sequenom inc. v. natera inc. 12 cv 0184 sequenom v. ariosa diagnostics inc. 12 cv 0189 u.s. district court southern district of california san diego and ariosa v. sequenom . verinatal health and stanford university later filed suit against sequenom in a dispute over the quake patent . 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 . 9 the 540 patent was invented by isis ltd. and expires in 2017 . stanford university owns the quake patents and licensing rights ; verinata is its exclusive licensee . 9 in april 2012 sequenom acquired two pending patents from helicos biosciences . in consideration for the sale and transfer of the purchased assets sequenom paid helicos 1.3 million . the helicos patent applications us patent application 12 709 057 and 12 727 824 cover methods for detecting fetal nucleic acids and diagnosing fetal abnormalities . 10 in july 2012 the united states district court denied sequenom s motion for a preliminary injunction motion against ariosa diagnostics . 11 in august 2013 the court of appeals for the federal circuit vacated the district court decision and remanded that case to the district court . 12 in the ariosa litigation the district court n.d.cal . held that the 540 patent was invalid because it claimed a natural phenomenon the presence of cell free fetal dna fragments in maternal blood . on june 13 2015 the cafc affirmed the district court s judgment . 13 finally on december 2 2015 the federal circuit declined to rehear en banc . 14 sequredx scandal edit in 2009 sequenom center for molecular medicine scmm was expected to launch the sequredx prenatal screening tests for down syndrome and rhesus d. subsequent investigation revealed significant flaws in the studies of the test s effectiveness . 15 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 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 . 16 she died on february 26 2011 . 17 18 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 . 19 sequenom executives are under investigation by the sec for insider trading before announcement of problems with the test . 20 21 on september 1 2011 sequenom entered into a cease and desist order with sec . 22 maternit21 plus edit maternit21 plus is sequenom center for molecular medicine s prenatal test for trisomy 21 down syndrome trisomy 18 edwards syndrome and trisomy 13 patau syndrome . the test operates by sampling cell free dna in the mother s blood which contains some dna from the fetus . the proportions of dna from sequences from chromosome 21 18 or 13 can indicate whether the fetus has trisomy in that chromosome . in a randomized controlled trial of 1 696 pregnancies at high risk for down syndrome the test correctly identified 98.6 % of the actual cases of down syndrome 209 out of 212 with a false positive rate of 0.2 % 3 of 1471 pregnancies without down ; the test gave no result in 0.8 % of the cases tested 13 of 1696 . 23 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 . 23 because amniocentesis and chorionic villus sampling are invasive they have a chance of causing miscarriage . 24 history edit on august 4 2011 sequenom said it would call its new blood test for down syndrome in pregnancy maternit21 when the product went on sale in the united states . 25 26 27 28 on august 11 2011 sequenom announced european licensing agreement with lifecodexx . the companies 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 the initial five year licensing agreement sequenom 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 . 29 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 . 30 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 . 31 on october 17 2011 sequenom center for molecular medicine announced the launch of maternit21 noninvasive prenatal test for down syndrome . 28 massarray analyzer 4 edit sequenom oncomap version 3 core set interrogates 450 mutations in 35 genes . an extended set interrogates 700 mutations in 113 genes . 32 sequenom oncocarta oncomap identifies 396 unique druggable or actionable mutations in 33 cancer genes . in total 417 mutations are identified . 33 34 35 36 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 . 37 iplex adme pgx panel on massarray system edit on october 4 2011 sequenom introduced iplex adme pgx panel on massarray system developed to genotype polymorphisms in genes associated with drug absorption distribution metabolism and excretion adme . 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 . 38 references edit sequenom sells bioscience unit . genetic engineering & biotechnology news . sequenom acquired by labcorp for 371 million . san diego business journal . july 27 2016 . retrieved 30 july 2016 . ariosa diagnostics . ariosa . a noninasive test to determine paternity in pregnancy . the new england journal of medicine . verinata . verinata . the panorama prenatal test natera . genesecurity.net . retrieved 2012 09 23 . non invasive prenatal test for down s syndrome developed . bionews . sequenom accuses aria natera of patent infringement . businessweek . january 26 2012 . a b courthouse news service . courthousenews.com . february 24 2012 . business wire april 16 2012 . helicos biosciences corporation announces prenatal diagnostics ip sale to sequenom . business wire . update 1 u.s. court denies sequenom s motion against ariosa . reuters . july 6 2012 . retrieved august 4 2012 . http www.cafc.uscourts.gov images stories opinions orders 12 1531 . opinion .8 7 2013.1.pdf http www.cafc.uscourts.gov images stories opinions orders 14 1139 . opinion .6 10 2015.1.pdf ariosa v. sequenom fed . cir . 2015 en banc petition denied pdf . cafc . december 2 2015 . retrieved february 3 2016 . sequenom shares plunge after probe reveals test flaws marketwatch sept. 28 2009 sec filing dead link elizabeth alice dragon obituary . east valley tribune . death of an insider r & d chief passes before she can testify in stock fraud case . cbs money watch . sequenom in 14 million settlement over test delay reuters jan 15 2010 sec filing . sec.gov . did sequenom insiders sell stock before data corruption was revealed jim edwards nov 10 2009 http www.sec.gov litigation admin 2011 34 65247.pdf a b palomaki ge . dna sequencing of maternal plasma to detect down syndrome an international clinical validation study . . genetics in medicine . noninvasive test identifies more than 98 % of down syndrome cases obg management . obgmanagement.com . darce keith . sequenom names new down syndrome genetic test . union tribune san diego . sequenom inc. reports financial results for the second quarter of 2011 aug 4 2011 . sequenom.investorroom.com . http www.sequenom.com files pdf documents maternit21 launch presentation a b 1 dead link 2 dead link http www.ispdhome.org public news 2011 ispd rapidresponse mps 24oct11.pdf 3 dead link 4 profiling critical cancer gene mutations in clinical tumor samples . plos one . march 2010 sequenom inc . sequenom.com . january 20 2010 . march 2011 sequenom inc . sequenom.com . november 1 2005 . massarray analyzer 4 sequenom inc . sequenom.com . massarray spectrometry is more sensitive th ... j clin microbiol . 2011 pubmed ncbi . ncbi.nlm.nih.gov . april 4 2012 . 5 dead link external links edit sequenom s company website retrieved from https en.wikipedia.org w index.php title sequenom & oldid 732293932 categories companies in the nasdaq biotechnology indexbiotechnology companies of the united statesgenomics companiesmicroarrayscompanies listed on nasdaqhidden categories all articles with dead external linksarticles with dead external links from june 2012use mdy dates from june 2012articles lacking reliable references from october 2011all articles lacking reliable references navigation menu personal tools not logged 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