Sequenom is a biotechnology company, specializing in noninvasive methods of testing through molecular diagnostics and genetic analysis. It has various products registered under its name and trademarked. It uses its own technology to develop advance and specialized testing methods. The IMPACT DxTM system approval from the FDA, and the additional testing capabilities of MaterniT21TM, to be announced at the end of October, will be a good catalyst for the share prices.
Sequenom Inc. (SQNM) is a life sciences company that specializes in molecular diagnostics testing and genetic analysis. It targets and serves discovery and clinical research, and molecular diagnostics markets, by developing innovative technology, products, and diagnostic tests. These products help to find solutions for translational research, biomedical research, molecular medicine applications and livestock, agriculture and other areas of research, through the results of genomic science. The company has invested its efforts in the development and commercialization of various diagnostic areas including ophthalmology, noninvasive women's health related and prenatal diagnostics, and other medical conditions like infectious diseases, autoimmunity and oncology.
The company has operations in two segments viz. genetic analysis (Biosciences Division) and Molecular Diagnostics (Sequenom Center for Molecular Medicine or Sequenom CCM). Sequenom CCM is a whole owned subsidiary of Sequenom Inc. and is a molecular diagnostic laboratory which is CAP accredited and CLIA certified. It develops and commercializes laboratory-developed tests (LDTs) for prenatal and ophthalmic diseases and conditions. Sequenom holds the intellectual property for noninvasive prenatal testing and also hold worldwide licenses for the development and commercialization of diagnostic tests predicting the genetic disposition to late stage age related macular degeneration (AMD).
Sequenom Inc. has also received ISO certification for quality management system, which entails that the medical device manufacturing quality management system of the company, is up to the par with international standards. Furthermore, the company has trademark products of Sequenom Inc. are SEQUENOM®, MassARRAY® and IMPACT DxTM.
Sequenom Inc. competes with Beckman Coulter Inc., Ikonysis Inc., Verinata Health Inc., Fluidigm Corp., Celula Inc., Aria Diagnostics Inc., Natera, Life Technologies Corp., Biotage AB, Illumina Inc., Fluidigm Corp., Luminex, Ibis Biosciences Inc., and KBiosystems
The Sequenom Biosciences Division's MassARRAY® system is used for research purposes in institutes and companies worldwide for basic research, life science and agricultural genomics. The system comprises of software applications, hardware, and consumable chips and reagents. It uses MALDI-TOF Mass Spectrometry to detect nucleic acids and accurate quantification of genetic variability. The MassARRAY system provides consistent results for a spectrum of DNA/RNA analysis applications, these include mutation detection, single nucleotide polymorphism (SNP), genotyping, copy number variants analysis, and other structural genome variations. Research use application software operating on the MassARRAY system provides the aforementioned applications, along with the purchase of consumable chips and reagent sets. During the first half of 2013, the genetic analysis revenue showed a 3% decrease as compared to the first half of 2012.
The MaterniT21TM PLUS is the pioneer in commercial noninvasive prenatal test (NIPT), used to detect the chromosomal anomaly Trisomy 21 which is most widespread cause of Down Syndrome. It uses the SEQureDx® technology, developed by Sequenom, to isolate and analyze circulating cell free fetal nucleic acid from the maternal blood sample. It's being used in diagnostics and is a success. Recently an enhanced version of the MaterniT21TM PLUS was launched. The reporting on the select, clinically relevant microdeletions that include Cri-du-chat syndrome, deletion syndrome (diGeorge), 1p36 deletion syndrome, Prader-Willi/Angelman syndrome and trisomies 16 and 22, will begin in the last week of October. The method validation study of MaterniT21TM demonstrated a high performance with >99% specificity.
RetnaGeneTM AMD identifies the high risk of AMD through noninvasive means. It has the potential to improve clinical management. Another product used for diagnostics is Heredi-TTM that analyzes disease-causing mutations through cystic fibroses carrier screen.
Currently, the Sequenom stock is rated overweight by the analysts, which indicates that the stock is expected to rise over the period of next few months. The mean sell side target price for Sequenom is around $5.4 which is a considerable upside to current valuations of $2.34. Despite these optimistic targets the shares are down almost 30% in the last 52-weeks. Intersting the sell side expects its 2014 earnings to be around $250 million which pretty near its current market capitalization.
In early October, Sequenom submitted the Premarket 510(k) Notifications to the United States Food and Drug Administration (FDA) for its research-use-only IMPACT DxTM system and IMPACT DxTM Factor V Leiden and Factor II Genotyping Test. This allows for the transition of the MassARRAY® system in to the clinical diagnostic field. The company is in the final stages of commercializing the IMPACT DxTM system in various countries requiring the CE mark in Europe. This step may have a major impact on the stock prices.
On October 22, 2013 Sequenom launched the Enhanced Sequencing Series for its MaterniT21TM PLUS laboratory-developed test (LDT). This test will report additional findings on subchromosomal microdeletions and autosomal trisomies for chromosome 16 and 22. In the last week of October, Sequenom Laboratories will start reporting on certain select clinically relevant microdeletions. The MaterniT21 PLUS test has demonstrated high performance in method validation study, hence positive results are expected by the end of October.
The company is in patent litigation with Ariosa Diagnostics Inc., Natera Inc., and Verinata Health Inc. It involves Sequenom's claim against the said companies for violation of the patent exclusively licensed to Sequenom. Further, Verinata has claims against Sequenom for violating their exclusive patent. The trial date has not yet been scheduled for the cases. However, on November 6, 2013 a case management conference will take place, determining the dynamics and plans of the trial. This event may prove to be a catalyst as and when the trial date is announced and the consequent decisions.
Sequenom Inc. will announce the 3rd Quarter financial results for 2013 on November 7, 2013. This will allow for the investors to better understand the financial position of the company and make informed decisions. The chairman and CEO of Sequenom, Harry F. Hixson, Jr. (Ph.D.) along with other senior management members, will host a conference call on the same day i.e. November 7th. The Sequenom website will feature the live webcast of the conference call. This conference call may act as a major catalyst for the share prices depending on the information relayed.
Sequenom is participating in the American Society for Human Genetics (ASHG) meeting, being held from October 22, 2013 to October 26, 2013. It will also exhibit in the European Molecular Biology Laboratories (EMBL) Conference on Cancer Genomics, from November 3 to November 5, 2013. News from the above mentioned events may have a positive impact on the company's share prices.
Sequenom Inc. has various technology products that are being used in clinical diagnostics and have the potential for success. It is aiming for commercializing its products which will bring in more revenues. Further, there was a 316% increase in the revenues of molecular diagnostic in the first half of 2013, as compared to the first half of 2012.
Sequenom has the potential to attract investors, since its products are faring successfully. Furthermore, the upcoming conferences and financial results have the potential to act as a positive catalyst. The commercialization European with CE marking can also positively impacting valuations.
It should also be noted that shares of the company have traded as high as $25 in the past and susceptible to the same inherent risks of all biotechnology companies. Short term investors can play above mentioned events for short term profits but long term investors are advised to do their own due diligence before making any long term investments.