SEQUENOM INC. NEW läuft weiter megamässsig!!
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Und in welcher Phase befindet sich das Medikament ?? Phase 1,2....3...??
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und das wird wie gesagt zum testen eingesetzt, nicht zur behandlung. Denke, da gibt's nicht diese Phasen wie bei den medikamenten selbst.
"The AttoSense HPV assay detects, identifies, and quantifies each of 15 HPV types associated with cervical cancer in a single reaction. Preliminary research studies show that the test can measure and reproducibly detect as few as 50 DNA copies for each of the 15 HPV genotypes in liquid cytology samples from cervical smears and tissue biopsy samples. The AttoSense test is currently available for Research Use Only. SEQUENOM intends to seek FDA and EU approvals as soon as practical. SEQUENOM will continue to collaborate with major medical centers to further validate and demonstrate the performance and value of the AttoSense HPV test." (aus dem Link oben)
Da steht drin, dass es momentan nur zur recherche zugelassen ist, aber dass die Firma die FDA und EU Zulassung "so schnell, wie es praktisch ist" beantragen will . . . dann steht noch da, dass der Wert und die Leistung des AttoSense HPV tests jetzt noch weiter validiert werden.... wischi waschi vage ist das schon, aber ich bin da ganz zuversichtlich. man bedenke, das ist die Firma, die bei dem DownSyndrometest nen Schummler im Team hatte... die Aktie ist momentan nur 30% wert von dem, was sie zuvor noch kostete. Das wird schon :)
Aber: Es ist noch viel mehr drin...wartets ab!
Gruß vom
Abachonär
(der euch auch mal die "ARCA-Biopharma"-Aktie UNVERBINDLICH ZUM ANSCHAUEN "empfiehlt, auch ein sehr interessanter Chart...)
Kein Comeback
Noch Ende Juli hatte DER AKTIONÄR auf ein Comeback der Sequenom-Aktie spekuliert. Doch dieses scheint nach den Geschehnissen von gestern ausgeschlossen. Das Unternehmen dürfte vorerst jegliches Vertrauen bei den Anlegern verspielt haben. Die Verluste von 44 Prozent nach Börsenschluss in den USA dürften nur der Auftakt für ein "Blutbad" im heutigen Handel gewesen sein. Wer noch investiert ist, sollte seine Position schnellstmöglich glattstellen.
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frage ich mich schon, ob frage ich mich schon, es so einfach ist und die Firmea keinen cent mehr Wert ist?
Sequenom hat ein laufendes Geschäft mit DNA/RNA Analyzern und hat gerade den ersten Test fertig gestellt in Cystric Fibrosis, der eine Marktgröße von ca. 300 MM USD hat. Weitere sind im Kommen...
Ich bin wahrhaftig kein Freund dieser Firma mehr nachdem was dort passiert ist, trotzdem sollte man auch nicht vergessen,d ass es hier nicht um eine kleine Biotech Firma ging, die nur einen Blockbuster in der Pipeline hatte. Selbst was der Test auf DownSyndrom anbelangt mag es ja so sein, dass die Firma kein fertiges Protokoll entwickelt hat diesen Test schnell zu kommerzialisieren, trotzdem wird immer wieder darauf hingewiesen, dass die Technologie dahinter wohl funkktioniert.
Meines Erachtens muss die Firma, wenn sie denn noch eine Chance haben will ihr Cash Burn drastisch verringern, d.h. den Laden verkleinern, restrukurieren und eine vernünftige Abschätzung vorlegen, ob und bis wann der Downe Syndrom Test noch entwickelt werden kann.
ZUm zweiten muss ein enues Management her, das das alles macht.
Ich frage mich ja auh, ob nicht die Investoren, die jetzt so jammern, nicht letztendlich auch die sind, die solchen Bioetchs immer so hoch pushen und letztendlich solchen Betrügereien Vorschub leisten...Man man sich das mal überlegen, dass die schon ne Mrktkapitaliseirung von 1 Mrd USD und mehr hatten...
Der aktuelle Preis entspricht wohl jetzt wieder ehen dem,was Sequenom wirklich wert ist
Quelle: http://www.streetinsider.com/Trader+Talk/...SQNM)+to+Buy/5862310.html
Sequenom heute gut beobachten! Könnte sehr interessant werden.! Mehrere Analysten haben das Kursziel deutlich angehoben!
23:25 08.01.14
PR Newswire
SAN DIEGO, Jan. 8, 2014
SAN DIEGO, Jan. 8, 2014 /PRNewswire/ -- Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative testing and genetic analysis solutions, today announced that on January 1, 2014, the European Patent Office (EPO) issued patent EP2183693 B1, entitled "Diagnosing Fetal Chromosomal Aneuploidy Using Genomic Sequencing," invented by Drs. Dennis Lo, Rossa Chiu, and Kwan Chee Chan of The Chinese University of Hong Kong. The patent claims novel methods for detecting fetal aneuploidy using sequencing and was the first patent filing made in the EPO directed to such novel methods. Sequenom holds exclusive rights to the patent, an important part of Sequenom's prenatal diagnostic patent portfolio, with coverage across all countries in the European Union, and also including Liechtenstein, Monaco, Norway and Switzerland.
About Sequenom
Sequenom, Inc. (NASDAQ: SQNM) is a life sciences company committed to improving healthcare through revolutionary genomic and genetic analysis solutions. Sequenom develops innovative technology, products and diagnostic tests that target and serve discovery and clinical research, and molecular diagnostic markets. The company was founded in 1994 and is headquartered in San Diego, California. Sequenom maintains a Web site at http://www.sequenom.com to which Sequenom regularly posts copies of its press releases as well as additional information about Sequenom. Interested persons can subscribe on the Sequenom Web site to email alerts or RSS feeds that are sent automatically when Sequenom issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the Web site.
Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Sequenom's commitment to improving healthcare through revolutionary genetic analysis solutions, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with Sequenom's ability to develop and commercialize new technologies and products, particularly new technologies such as prenatal and other diagnostics and laboratory developed tests, Sequenom's ability to manage its existing cash resources or raise additional cash resources, competition, intellectual property protection and intellectual property rights of others, government regulation particularly with respect to diagnostic products and laboratory developed tests, obtaining or maintaining regulatory approvals, ongoing litigation including patent litigation, and other risks detailed from time to time in Sequenom's most recent Quarterly and Annual Reports on Securities and Exchange Commission Forms 10-Q and 10-K, respectively, and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and Sequenom undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
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22:35 09.01.14
PR Newswire
SAN DIEGO, Jan, 9, 2014
SAN DIEGO, Jan, 9, 2014 /PRNewswire/ -- Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative testing and genetic analysis solutions, announced today its wholly owned subsidiary, Sequenom Laboratories, has signed a national agreement with a leading benefits provider, to provide coverage for the MaterniT21™ PLUS laboratory-developed test (LDT). The addition of this contract brings the number of covered lives under agreement by Sequenom Laboratories' diagnostic services to more than 113 million.
"We are excited to be working with an additional national payor to provide coverage for the MaterniT21 PLUS test. We believe this coverage will provide health care providers and their patients greater access to our market-leading noninvasive prenatal test for pregnant women at increased risk for fetal chromosome abnormalities," said William Welch, President and COO, Sequenom. "This agreement is an extension of Sequenom Laboratories' goal to provide broader coverage and availability for its testing services within the US."
The MaterniT21 PLUS test analyzes the relative amount of 21, 18, 13, as well as X and Y chromosomal material in cell-free DNA. The test also reports additional findings for the presence of subchromosomal microdeletions and duplications which complement the MaterniT21 PLUS test core findings. The test is intended for use in pregnant women at increased risk for fetal chromosomal abnormalities and is indicated for use as early as 10 weeks' gestation. Estimates suggest there are about 750,000 pregnancies at high risk for fetal chromosomal abnormalities each year in the United States.
The MaterniT21 PLUS test is available exclusively through Sequenom Laboratories as a testing service provided to health care professionals. To learn more about the test, please visit www.laboratories.sequenom.com.
About Sequenom
Sequenom, Inc. (NASDAQ: SQNM) is a life sciences company committed to improving healthcare through revolutionary genomic and genetic analysis solutions. Sequenom Bioscience develops innovative technology, products and tests that target and serve discovery and clinical research, and molecular diagnostic markets. The company was founded in 1994 and is headquartered in San Diego, California. Sequenom maintains a Web site at http://www.sequenom.com to which Sequenom regularly posts copies of its press releases as well as additional information about Sequenom. Interested persons can subscribe on the Sequenom Web site to email alerts or RSS feeds that are sent automatically when Sequenom issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the Web site.
About Sequenom Laboratories
Sequenom Laboratories, a CAP accredited and CLIA-certified molecular diagnostics laboratory, has developed a broad range of laboratory-developed tests, with a focus on prenatal and ophthalmological diseases and conditions. Branded under the names SensiGene™, MaterniT21™ PLUS, HerediT™, NextView™ and RetnaGene™, these molecular genetic laboratory-developed tests provide early patient management information for obstetricians, geneticists, maternal fetal medicine specialists and ophthalmologists. Sequenom Laboratories is changing the landscape in genetic disorder diagnostics using proprietary cutting edge technologies.
SEQUENOM®, MaterniT21™ PLUS, SensiGene™, HerediT™, NextView™ and RetnaGene™ are trademarks of Sequenom, Inc. All other trademarks and service marks are the property of their respective owners.
Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Sequenom's (including Sequenom, Inc. and Sequenom Laboratories) expectations regarding performance under, or the benefits or impact of the national payor agreement on Sequenom, patients, and health care providers, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with reliance upon the collaborative efforts of the national payor, Sequenom's ability to develop and commercialize new technologies and products, particularly new technologies such as prenatal and other diagnostics and laboratory developed tests, Sequenom's ability to manage its existing cash resources or raise additional cash resources, competition, intellectual property protection and intellectual property rights of others, government regulation particularly with respect to diagnostic products and laboratory-developed tests, obtaining or maintaining regulatory approvals, ongoing litigation including patent litigation, and other risks detailed from time to time in Sequenom, Inc.'s most recent Quarterly and Annual Reports on Securities and Exchange Commission Forms 10-Q and 10-K, respectively, and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and Sequenom undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
(Logo: http://photos.prnewswire.com/prnh/20040415/SQNMLOGO)
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17:05 12.01.14
PR Newswire
SAN DIEGO, Jan. 12, 2014
SAN DIEGO, Jan. 12, 2014 /PRNewswire/ -- Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative testing and genetic analysis solutions, today announced preliminary highlights of the Company's 2013 performance, accomplishments and outlined key corporate objectives for 2014.
Preliminary 2013 Performance Results (unaudited)
Total revenue of approximately $162 million, showing growth of approximately 81% year-over-year for 2013
Diagnostic services revenues of approximately $120 million, as compared to $46.5 million in 2012. Diagnostic services revenues continue to be recorded primarily as cash is received
High margin stable revenue in the Sequenom Bioscience business of over $42 million
Total cash, cash equivalents and marketable securities as of December 31, 2013 were approximately $71 million
Cash burn was reduced to approximately $14 million for the fourth quarter of 2013
Unrecorded diagnostic accounts receivable are estimated to be $46 to $51 million as of December 31, 2013
Recent Key Accomplishments
More than 185,000 total commercial prenatal and retinal diagnostic test samples were accessioned during 2013, as compared to 92,000 in 2012
Strong increases achieved in the adoption rate and sales of Sequenom Laboratories' MaterniT21 PLUS™ laboratory-developed test (LDT):
Approximately 148,500 MaterniT21 PLUS test high-risk commercial samples were accessioned in 2013, 140% more than in 2012; 93% of accessions were from U.S. patients
MaterniT21 PLUS Enhanced Sequencing Series introduced in Q4 2013
Approximately 113 million lives now under coverage with a growing number of payor contracts, including 2 national payors
Receiving reimbursement as an out-of-network laboratory from remaining large commercial payors
Medicaid volume was reduced to 14% of accessions in Q4 2013 from 25% in Q1 2013; eight state Medicaid payors are now reimbursing
Laboratory location in North Carolina fully operational and currently performing approximately one third of MaterniT21 PLUS tests
Mayo Clinic and Sequenom Laboratories partnered to provide access to the MaterniT21 PLUS LDT to the physicians and their patients in the Mayo Clinic network
Massively parallel sequencing (MPS) patent issued in Europe, further strengthening Sequenom's prenatal diagnostic patent portfolio
"We overcame many significant challenges in 2013, including the coding changes that resulted in delays or reduced reimbursement by many payors, particularly state Medicaid programs. As we move into 2014, we continue to lead the industry in expanding the use of and reimbursement for noninvasive prenatal testing (NIPT), and continue to work with payors to gain coverage for our tests," said Harry F. Hixson, Jr., Ph.D., Chairman and CEO of Sequenom. "We have set high goals for 2014, and we expect to achieve these goals to continue to build value for our shareholders and maintain our leadership position in NIPT."
Key Objectives for 2014
The Company has established its primary financial and R&D objectives for 2014 to include:
Achieve quarterly break-even and positive cash flow in Q4 2014
Expand the NIPT menu with the development of a low cost test on an alternative platform by year-end, which we expect will facilitate international access and potential future entry into the low-risk market
On Thursday, January 16, at 2:00 pm PT (5:00 pm ET), Harry F. Hixson, Jr., Ph.D., William Welch, President and COO, and Paul V. Maier, CFO, will present an overview of and update on the Company at the JP Morgan 32nd Annual Healthcare Conference in San Francisco, CA.
The presentation is expected to last approximately 30 minutes and will be webcast live through the "Investors" section of the Sequenom website at www.sequenom.com. An audio replay will be available for 30 days following the initial presentation webcast. The presentation is currently posted on the Company's website.
This press release contains certain unaudited financial results for the Company's fiscal year and fourth quarter ended December 31, 2013. These unaudited results may change as a result of further review by the Company's management and its independent auditors. The completion of the audit of our financial results for 2013 could result in changes to the unaudited financial results presented in this press release and may identify issues related to the effectiveness of the Company's internal controls over financial reporting.
About Sequenom
Sequenom, Inc. (NASDAQ: SQNM) is a life sciences company committed to improving healthcare through revolutionary genomic and genetic analysis solutions. Sequenom develops innovative technology, products and diagnostic tests that target and serve discovery and clinical research, and molecular diagnostics markets. The company was founded in 1994 and is headquartered in San Diego, California. Sequenom maintains a Web site at http://www.sequenom.com to which Sequenom regularly posts copies of its press releases as well as additional information about Sequenom. Interested persons can subscribe on the Sequenom Web site to email alerts or RSS feeds that are sent automatically when Sequenom issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the Web site.
About Sequenom Laboratories
Sequenom Laboratories, a CAP accredited and CLIA-certified molecular diagnostics laboratory, has developed a broad range of laboratory tests with a focus on prenatal and ophthalmological diseases and conditions. Branded under the names SensiGene™, MaterniT21 PLUS™, HerediT™, NextView™ and RetnaGene™, these molecular genetic laboratory-developed tests provide early patient management information for obstetricians, geneticists, maternal fetal medicine specialists and ophthalmologists. Sequenom Laboratories is changing the landscape in genetic disorder diagnostics using proprietary cutting edge technologies.
SEQUENOM®, MaterniT21™ PLUS, SensiGene™, HerediT™, NextView™, RetnaGene™, IMPACT Dx™ and MassArray® are trademarks of Sequenom, Inc. All other trademarks and service marks are the property of their respective owners.
Forward-Looking Statement
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the Company's objectives for 2014 including primary financial and R&D objectives, expectations of continued reimbursement from large commercial payors, the Company's expectations to continue to lead the industry in expanding the use of and reimbursement for noninvasive prenatal testing (NIPT) and to work with payors to gain coverage for its tests, the Company's goals for 2014 and expectations to achieve those goals to continue to build value for shareholders and maintain its leadership position in NIPT, further review of financial results for the fiscal year and quarter ended December 31, 2013 to be conducted by the Company's management and its independent auditors, the completion of the audit of the Company's financial results for 2013 and its potential change or impact on the unaudited financial results presented herein and/or identification of issues related to the effectiveness of the Company's internal controls over financial reporting, and the Company's commitment to improving healthcare through revolutionary genomic and genetic analysis solutions are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with market demand for and acceptance and use of technology and tests such as the MaterniT21 PLUS test, reliance upon the collaborative efforts of other parties such as, without limitation, healthcare providers, international distributors and licensees, the Company or third parties obtaining or maintaining regulatory approvals that impact the Company's business, government regulation particularly with respect to diagnostic products and laboratory developed tests, publication processes, the performance of designed product enhancements, the Company's ability to develop and commercialize technologies and products, particularly new technologies such as noninvasive prenatal diagnostics, laboratory developed tests, and genetic analysis platforms, the Company's financial position, the Company's ability to manage its existing cash resources or raise additional cash resources, competition, intellectual property protection and intellectual property rights of others, litigation involving the Company, and other risks detailed from time to time in the Company's most recently filed Quarterly Report on Form 10-Q for the quarter ended September 30, 2013 and its Annual Report on Form 10-K for the year ended December 31, 2012, and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
(Logo: http://photos.prnewswire.com/prnh/20040415/SQNMLOGO)
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22:35 14.01.14
PR Newswire
SAN DIEGO, Jan. 14, 2014
SAN DIEGO, Jan. 14, 2014 /PRNewswire/ -- Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative testing and genetic analysis solutions, announced today its wholly owned subsidiary, Sequenom Laboratories, entered into an agreement to offer access to its MaterniT21™ PLUS laboratory-developed test to Mayo Medical Laboratories.
"We are delighted to expand our offerings to our national clients to offer the MaterniT21 PLUS test to physicians who have patients who are at high risk for fetal chromosomal abnormalities," says Dr. Franklin Cockerill, III, M.D, Chief Executive Officer of Mayo Medical Laboratories.
"Mayo Clinic is clearly committed to research, innovation and patient care, and we welcome this arrangement with them to expand access to our MaterniT21 PLUS test," said William Welch, President and COO of Sequenom, Inc.
Sequenom Laboratories was the first to market a noninvasive prenatal laboratory-developed test for fetal chromosomal aneuploidies. The MaterniT21 PLUS test analyzes the relative amount of 21, 18, 13, as well as X and Y chromosomal material in cell-free DNA. The test also reports additional findings for the presence of subchromosomal microdeletions and duplications which complement the MaterniT21 PLUS test core findings. The test is intended for use in pregnant women at increased risk for fetal chromosomal abnormalities and is indicated for use as early as 10 weeks' gestation. Estimates suggest there are about 750,000 pregnancies at high risk for fetal chromosomal abnormalities each year in the United States. The MaterniT21 PLUS test is available exclusively through Sequenom Laboratories as a testing service provided to physicians. To learn more about the test, please visit www.laboratories.sequenom.com.
About Sequenom
Sequenom, Inc. (NASDAQ: SQNM) is a life sciences company committed to improving healthcare through revolutionary genomic and genetic analysis solutions. Sequenom develops innovative technology, products and diagnostic tests that target and serve discovery and clinical research, and molecular diagnostic markets. The company was founded in 1994 and is headquartered in San Diego, California. Sequenom maintains a Web site at http://www.sequenom.com to which Sequenom regularly posts copies of its press releases as well as additional information about Sequenom. Interested persons can subscribe on the Sequenom Web site to email alerts or RSS feeds that are sent automatically when Sequenom issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the Web site.
About Sequenom Laboratories
Sequenom Laboratories, a CAP accredited and CLIA-certified molecular diagnostics laboratory, has developed a broad range of laboratory tests, with a focus on prenatal and ophthalmological diseases and conditions. Branded under the names SensiGene™, MaterniT21™ PLUS, HerediT™, NextView™ and RetnaGene™, these molecular genetic laboratory-developed tests provide early patient management information for obstetricians, geneticists, maternal fetal medicine specialists and ophthalmologists. Sequenom Laboratories is changing the landscape in genetic disorder diagnostics using proprietary cutting edge technologies.
Sequenom®, MaterniT21™ PLUS, SensiGene®, HerediT™, NextView™, and RetnaGene™ are trademarks of Sequenom, Inc. All other trademarks and service marks are the property of their respective owners.
About Mayo Medical Laboratories
Mayo Clinic offers proven diagnostic tests to more than 5,000 health care institutions around the world through Mayo Medical Laboratories, Mayo Clinic's reference laboratory. Revenue from Mayo Medical Laboratories' testing is used to support medical education and research at Mayo Clinic. www.MayoMedicalLaboratories.com
Forward-Looking Statement
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Sequenom's (including Sequenom, Inc. and Sequenom Laboratories) expectations regarding performance under, or the benefits or impact of the agreement with Mayo Medical Laboratories on Sequenom, physicians, patients, and healthcare, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with reliance upon the collaborative efforts of Mayo Medical Laboratories, Sequenom's ability to develop and commercialize new technologies and products, particularly new technologies such as prenatal and other diagnostics and laboratory developed tests, Sequenom's ability to manage its existing cash resources or raise additional cash resources, competition, intellectual property protection and intellectual property rights of others, government regulation particularly with respect to diagnostic products and laboratory developed tests, obtaining or maintaining regulatory approvals, ongoing litigation including patent litigation, and other risks detailed from time to time in Sequenom, Inc.'s most recent Quarterly and Annual Reports on Securities and Exchange Commission Forms 10-Q and 10-K, respectively, and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and Sequenom undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
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00:00 17.01.14
PR Newswire
SOPHIA ANTIPOLIS, France and SAN DIEGO, Jan. 16, 2014
SOPHIA ANTIPOLIS, France and SAN DIEGO, Jan. 16, 2014 /PRNewswire/ -- Nicox S.A. (NYSE Euronext Paris: COX), and Sequenom, Inc. (NASDAQ:SQNM), today announced that their affiliate companies (Nicox Inc. and Sequenom Laboratories) have entered into an exclusive agreement in the age-related macular degeneration (AMD) field. As part of this agreement, Nicox has been granted the North American promotional rights to the Sequenom Laboratories RetnaGene™ AMD laboratory-developed test, for the evaluation of a patient's risk of AMD disease progression within 2, 5 and 10 years. The RetnaGene AMD test will be promoted by the same Nicox U.S. sales force which recently launched Sjo™, an advanced diagnostic panel for the early detection of Sjogren's Syndrome. Nicox expects to begin promoting the RetnaGene AMD test in the United States in the first half of 2014.
Jerry St. Peter, Executive Vice President and General Manager of Nicox Inc., said, "AMD affects approximately 15 million people in the United States and is a leading cause of vision loss in Americans aged 60 and over1. The ability to identify those patients most at risk of progressing to wet AMD represents a major opportunity to optimize the management of their disease. We are delighted to have formed this agreement with Sequenom Laboratories to market the RetnaGene AMD test, which fits perfectly within our diagnostics portfolio, and potentially other novel genetic tests in the future. With Sjo™, AdenoPlus® and now the RetnaGene AMD test, Nicox is further strengthening its position with ophthalmic diagnostics by continually bringing innovative tests to eye care professionals in North America."
"We are pleased to collaborate with Nicox to expand access to the RetnaGene AMD testto clinicians and their patients, and we are confident in Nicox's ability to leverage its growing sales team and expertise in the ophthalmic arena to successfully market the test," said William Welch, President and COO of Sequenom, Inc.
Terms of the agreement
Under the terms of the agreement, Sequenom Laboratories will grant Nicox exclusive rights to promote the RetnaGene AMD laboratory-developed test to eye care practitioners in North America (United States, Canada, Puerto Rico and Mexico) and co-exclusive rights towards specialized retina physicians. Sequenom Laboratories will provide the sample collection materials and will perform the testing in its CLIA-certified laboratory at an agreed price to Nicox. Further, Sequenom Laboratories will contribute existing commercial and clinical expertise, and marketing intelligence to expedite increased market demand and uptake within the general ophthalmology and optometry segments. Nicox will be responsible for all marketing and promotional activities, and will directly promote the RetnaGene AMD testing service to eye care practitioners.
The agreement also grants Nicox exclusive rights to an additional AMD laboratory-developed test currently in late-stage development and as well an exclusive option on further laboratory-developed tests developed by Sequenom Laboratories that are applicable in the ophthalmic space.
About the RetnaGene AMD test
The RetnaGene AMD test is a laboratory-developed test developed and validated exclusively by Sequenom Laboratories to evaluate the risk of early or intermediate Age-related Macular Degeneration (AMD) progressing to choroidal neovascularization (CNV), also known as wet AMD, within 2, 5 and 10 years. Wet AMD is characterized by abnormal growth and leakage of blood vessels in the macula, the center of the retina, leading to a loss of central vision.
The RetnaGene AMD test is an accurate, safe and noninvasive test that uses a DNA sample collected from a buccal (cheek) swab. The patient's risk of progressing to advanced choroidal neovascular disease within 2, 5 and 10 years is assessed based on four risk factors: genotype, phenotype (severity of the existing symptoms), age and environment (smoking status). Up to 70% of disease risk is inherited and predominantly caused by variations in a handful of genes discovered over the last 5 to 10 years. Most of the affected genes have been identified in regulatory proteins contained within the alternative complement system involved in innate immunity. Sequenom Laboratories' RetnaGene AMD test includes all of the major single nucleotide polymorphisms (SNPs) that have been proven to have the most significant effect on the risk of developing advanced AMD disease. The RetnaGene AMD test is the only test to date with 100% of SNPs validated using the Age Related Eye Disease Study (AREDS) patient samples, one of the largest clinical trials on AMD, which was sponsored by the National Eye Institute2. The results of the test will provide a clinician with an individual's risk score for progression to CNV, in order to optimize patient management with the goal of preserving vision.
About Age-related Macular Degeneration (AMD)
AMD is a progressive eye disorder which starts with small yellow deposits on the retina and can evolve in two different advanced forms called dry AMD and wet AMD. In the dry AMD form, geographic atrophy is considered the late stage of the disease. Wet AMD (also called neovascular AMD) is characterized by abnormal growth of fragile and leaky blood vessels, known as choroidal neovascularization in the macula (the small area at the center of the retina, where vision is keenest) in response to chronic inflammatory stress. Wet AMD causes profound loss of central vision and is a leading source of legal blindness in people over age 50 in the developed world. Late stage AMD represents 10 to 15% of all AMD cases and is estimated to affect at least 1.75 million patients in the US3.
References
1 Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis, Wong WL, Su X, Li X, Cheung CM, Klein R, Cheng CY, Wong TY, The Lancet Global Health, Early Online Publication 3 January 2014.
2 Inclusion of genotype with fundus phenotype improves accuracy of predicting choroidal neovascularization and geographic atrophy, Perlee LT, Bansal AT, Gehrs K, Heier JS, Csaky K, Allikmets R, Oeth P, Paladino T, Farkas DH, Rawlings PL, Hageman GS. Ophthalmology. 2013 Sep;120(9):1880-92
3 The prevalence of age-related eye diseases and visual impairment in aging: current estimates. Klein R, Klein BE. Invest Ophthalmol Vis Sci. 2013 Dec 13;54(14):ORSF5-ORSF13.
About Nicox
Nicox (Bloomberg: COX:FP, Reuters: NCOX.PA) is an emerging international company focused on the ophthalmic market. With a heritage of innovative R&D, business development and commercial expertise, the Nicox team is building a diversified portfolio of therapies and diagnostic tools that can help people to enhance their sight. The Company's commercial portfolio and near-term pipeline already include several innovative diagnostic tests intended for eye care professionals, as well as a range of eye care products. Nicox's key proprietary asset in ophthalmology is latanoprostene bunod, a novel compound based on Nicox's proprietary nitric oxide (NO)-donating R&D platform, currently in Phase 3 clinical development in collaboration with Bausch + Lomb for the potential treatment of glaucoma and ocular hypertension. Further NO-donors are under development, notably through partners.
Nicox is headquartered in France, with research capabilities in Italy, a growing commercial infrastructure in North America and in the major European markets and an expanding international presence through partners. Nicox S.A. is listed on Euronext Paris (Compartment B: Mid Caps). For more information on Nicox or its products please visit www.nicox.com.
About Sequenom
Sequenom, Inc. (NASDAQ: SQNM) is a life sciences company committed to improving healthcare through revolutionary genomic and genetic analysis solutions. The company was founded in 1994 and is headquartered in San Diego, California. Sequenom maintains a Web site at http://www.sequenom.com to which Sequenom regularly posts copies of its press releases as well as additional information about Sequenom. Interested persons can subscribe on the Sequenom Web site to email alerts or RSS feeds that are sent automatically when Sequenom issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the Web site.
About Sequenom Laboratories
Sequenom Laboratories, a CAP accredited and CLIA-certified molecular diagnostics laboratory, has developed a broad range of laboratory-developed tests, with a focus on prenatal and ophthalmological diseases and conditions. Branded under the names SensiGene™, MaterniT21™ PLUS, HerediT™, NextView™ and RetnaGene™, these molecular genetic laboratory-developed tests provide early patient management information for obstetricians, geneticists, maternal fetal medicine specialists and ophthalmologists. Sequenom Laboratories is changing the landscape in genetic disorder diagnostics using proprietary cutting edge technologies.
SEQUENOM®, MaterniT21™ PLUS, SensiGene™, HerediT™, NextView™, RetnaGene™, are trademarks of Sequenom, Inc. All other trademarks and service marks are the property of their respective owners.
Forward-Looking Statements
Nicox
This press release contains certain forward-looking statements. Although Nicox believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated in the forward-looking statements.
Risks factors which are likely to have a material effect on Nicox's business are presented in the 4th chapter of the « Document de reference, rapport financier annuel et rapport de gestion 2012 » filed with the French Autorite des Marches Financiers (AMF) on March 22, 2013 and available on Nicox's website (www.nicox.com) and on the AMF's website (www.amf-france.org).
Sequenom
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Sequenom's (including Sequenom, Inc. and Sequenom Laboratories) expectations regarding performance under, or the benefits or impact of the agreement with Nicox on Sequenom, physicians, patients, and healthcare, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with reliance upon the collaborative efforts of Nicox, Sequenom and Sequenom Laboratories ability to develop and commercialize new technologies and products, particularly new technologies such as opthalmic, prenatal and other diagnostics and laboratory-developed tests, Sequenom's ability to manage its existing cash resources or raise additional cash resources, competition, intellectual property protection and intellectual property rights of others, government regulation particularly with respect to diagnostic products and laboratory-developed tests, obtaining or maintaining regulatory approvals, ongoing litigation including patent litigation, and other risks detailed from time to time in Sequenom, Inc.'s most recent Quarterly and Annual Reports on Securities and Exchange Commission Forms 10-Q and 10-K, respectively, and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and Sequenom undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
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13:05 13.02.14
PR Newswire
SAN DIEGO, Feb. 13, 2014
SAN DIEGO, Feb. 13, 2014 /PRNewswire/ -- Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative diagnostic testing and genetic analysis solutions, today announced it will report financial results for the fourth quarter and full year of 2013 after closing of the NASDAQ Global Market on Thursday, February 27, 2014.
A conference call hosted by Harry F. Hixson, Jr., Ph.D., Chairman and CEO, and other members of senior management will take place on the same day at 5:00 pm EST (2:00 pm PST) and will be webcast live on the Sequenom Web site.
To access the live teleconference call, dial 877-883-0383 in the U.S. and Canada, and 412-902-6506 for other international callers. Please use code 3696874. If you are unable to listen to the live webcast, a teleconference replay will be available through Friday, March 21, 2014. Interested parties can access the replay by dialing 877-344-7529 or 412-317-0088 internationally and entering the conference number 10040837.
The conference call webcast is accessible through the "Investors" section of the Sequenom Web site at www.sequenom.com/invest. An online replay will be available following the initial broadcast until Friday, March 21, 2014.
About Sequenom
Sequenom, Inc. (NASDAQ: SQNM) is a life sciences company committed to improving healthcare through revolutionary genomic and genetic analysis solutions. The company was founded in 1994 and is headquartered in San Diego, California. Sequenom maintains a Web site at http://www.sequenom.com to which Sequenom regularly posts copies of its press releases as well as additional information about Sequenom. Interested persons can subscribe on the Sequenom Web site to email alerts or RSS feeds that are sent automatically when Sequenom issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the Web site.
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Achieve break-even and positive cash flow for the fourth quarter of 2014.
Expand the NIPT menu with the development of a low-cost test on an alternative platform by year-end, which we expect will facilitate international access and potential future entry into the low-risk market.http://www.ariva.de/news/...rth-Quarter-And-Full-Year-Of-2013-4947279
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PR Newswire
SAN DIEGO, March 3, 2014
SAN DIEGO, March 3, 2014 /PRNewswire/ -- Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative diagnostic testing and genetic analysis solutions, today announced the Company's participation at the 26th Annual Roth Conference at the Ritz Carlton in Dana Point, CA on March 9-12, 2014.
William Welch, President and Chief Operating Officer, and Carolyn D. Beaver, Vice President and Chief Accounting Officer, will present on Tuesday, March 11, beginning at 12:00 p.m. PT to provide an overview of and update on the Company. The presentation is expected to last approximately 25 minutes and will be webcast live through the "Investors" section of the Sequenom Web site at www.sequenom.com. An audio replay will be available for 30 days following the initial broadcast.
About Sequenom
Sequenom, Inc. (NASDAQ: SQNM) is a life sciences company committed to improving healthcare through revolutionary genomic and genetic analysis solutions. Sequenom develops innovative technology, products and diagnostic tests that target and serve discovery and clinical research, and molecular diagnostic markets. Website: www.sequenom.com
SEQUENOM logo.
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PR Newswire
SAN DIEGO, March 21, 2014
SAN DIEGO, March 21, 2014 /PRNewswire/ -- Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative diagnostic testing and genetic analysis solutions, today announced a resolution of litigation between the Company and Paul Hawran. Mr. Hawran served as the Company's Chief Financial Officer from April 2007 until September 2009. Mr. Hawran resigned in September 2009.
After September 2009, the Securities and Exchange Commission conducted an investigation concerning alleged inaccurate disclosures by the Company in 2008 and 2009. The Securities and Exchange Commission concluded its investigation without any action against Mr. Hawran.
About Sequenom
Sequenom, Inc. (NASDAQ: SQNM) is a life sciences company committed to improving healthcare through revolutionary genomic and genetic analysis solutions. Sequenom develops innovative technology, products and diagnostic tests that target and serve discovery and clinical research, and molecular diagnostic markets. Website: www.sequenom.com
SEQUENOM logo
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