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SQNM - Sector: Healthcare---Industry: Medical Equipment & Supplies

Started by wrangler, March 11, 2006, 04:43:23 AM

Previous topic - Next topic

setravis

SQNM  Sequenom CMM Commences Pivotal Clinical Validation Study... 
by PR Newswire  Dec 22 2010 4:30PM

SAN DIEGO, Dec. 22, 2010 /PRNewswire via COMTEX/ -- Sequenom, Inc. (SQNM) today announced that the company's wholly-owned reference laboratory, the Sequenom Center for Molecular Medicine (Sequenom CMM), has authorized commencement of a pivotal clinical validation study. This validation study is designed to evaluate the clinical performance of the SensiGene T21 Laboratory Developed Test (LDT) for the detection of an overabundance in maternal blood of chromosome 21, which is associated with fetal chromosome 21 aneuploidy. Testing of the clinical specimens will be performed at the Sequenom CMM facility in San Diego.


In September 2010, Sequenom CMM completed an R&D "locked-assay" verification study and the results of this study have been accepted for publication by the American Journal of Obstetrics and Gynecology. This "locked-assay" study was performed on the GAIIx sequencer (Illumina, Inc., CA). Subsequently the laboratory has been engaged in additional equivalency studies using the more advanced HiSeq 2000 sequencer (Illumina). Earlier this month, Sequenom CMM scientists and Sequenom's oversight committee reviewed data from the equivalency studies and authorized the start of the LDT clinical validation study using the HiSeq 2000.

Sequenom CMM-San Diego has received the first set of clinical specimens for the study and plans to start testing samples during the first week of January 2011.

"We are delighted that Sequenom CMM will initiate the LDT clinical validation study," said Harry F. Hixson, Jr., Ph.D., chairman and chief executive officer of Sequenom. "We remain very pleased with the results of the 480 sample R&D verification study that was completed in September 2010. Results from our just completed HiSeq 2000 equivalency study met pre-specified requirements that now allow us to proceed confidently with the validation study. The LDT clinical validation study is an important next step in confirming the trisomy 21 test performance in a large sample cohort."

Additionally, the company reports that Federal and State CLIA certificates were issued to Sequenom CMM-San Diego effective October 26, 2010.

About Sequenom Center for Molecular Medicine

Sequenom Center for Molecular Medicine (Sequenom CMM(R)) is a CAP-accredited and CLIA-certified specialty reference laboratory dedicated to the development and commercialization of laboratory-developed genetic testing services for prenatal and eye conditions. Utilizing innovative proprietary technologies, Sequenom CMM provides genetic testing results services upon orders from physicians. Working closely with key opinion leaders and experts in obstetrics, retinal care and genetics, Sequenom CMM scientists use a variety of sophisticated and cutting-edge methodologies in the development and validation of laboratory tests. Sequenom CMM is changing the landscape in genetic diagnostics. Visit http://www.scmmlab.com for more information on laboratory services.

About Sequenom

Sequenom, Inc. (SQNM, Trade ) is a life sciences company committed to improving healthcare through revolutionary 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.

SEQUENOM(R), Sequenom CMM(R), SensiGene(R) are trademarks of Sequenom, Inc. All other trademarks 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 the Company's expectations, plans, goals, purpose, design, and commencement and performance of the clinical validation study, including sample testing and the timing thereof, the impact of Sequenom CMM on genetic diagnostics, and the Company'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 the Company's ability to develop and commercialize new technologies and products, particularly new technologies such as noninvasive prenatal diagnostics and laboratory developed tests, reliance upon the collaborative efforts of other parties, the Company's ability to manage its existing 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 and investigations and other risks detailed from time to time in the Company's most recent Annual Report on Form 10-K 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.

SOURCE Sequenom, Inc.
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

Bullish Triangular Formation...
has formed on the point and figure chart. If there is a break out from this formation a minimum of 15 will be the price target. Maximum will be a count on the break out column of X's. Going to be an exciting year or two for SQNM.

Day's Range: 7.00 - 7.79
52wk Range: 4.69 - 8.20
Volume: 8,616,877
Avg Vol (3m): 2,533,160
Market Cap: 767.03M

Technicals
Close Above the 50-day EMA
Close Above the 13-day EMA
Most Actives
Gap Up
Percentage Gainer

Last Price Quote is:
9.72%above 13-day EMA
14.70%above 50-day EMA
RS Rating: 97 
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

May 6, 2011, 2:06 PM ET.Sequenom Flies Higher; Started at Buy at Auriga...

Biotech company Sequenom (SQNM) is up 13% today after posting better than expected earnings results  and announcing that it had completed a study of its down syndrome diagnostic test. Auriga analyst Peter McDonald initiated coverage of the company on Friday at Buy, and wrote that the company is making progress on both its down syndrome test and a test for age related macular degeneration. But the stock's gain actually eclipsed McDonald's price target of $7, which he set before the market opened, by the afternoon as it jumped to $7.54.

"Overall, it was a good quarter for Sequenom and the next several months promise to be a busy for news flow," McDonald wrote. "Sequenom has $125 million in cash and equivalents, enough to support operations through 2012 in our view."

A study of its down syndrome test was finished ahead of schedule, McDonald noted, and the macular degeneration test is on track for a mid-year commercial launch.

"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

Sequenom Enters Into New $30.0 Million Credit Facility...

Press Release Source: Sequenom, Inc. On Thursday June 2, 2011, 7:00 am EDT
SAN DIEGO, June 2, 2011 /PRNewswire/ -- Sequenom, Inc. (NASDAQ:SQNM ), a life sciences company providing innovative genetic analysis solutions, today announced it and its subsidiary Sequenom Center for Molecular Medicine® (Sequenom CMM) have secured a $30.0 million financing commitment from Silicon Valley Bank's San Diego-based team. Sequenom will use proceeds from the facility to support the development and commercialization of new products and other near term growth initiatives.

The credit facility consists of a term loan of up to $20.0 million, and a $10.0 million revolving line of credit to be used for the purchase of capital equipment to expand laboratory capacity and to fund working capital requirements, accounts receivable and inventory as Sequenom CMM prepares to commercialize and launch new laboratory developed tests. 

"The addition of this new credit facility enables us to extend the runway provided by financings put in place over the last year and to maintain a consistent level of liquidity as we move into an active growth phase for the company," said Paul V. Maier, CFO of Sequenom, Inc. 

The Sequenom CMM laboratory in San Diego, Calif. was recently awarded accreditation by the Accreditation Committee of the College of American Pathologists (CAP), while the laboratory based in Grand Rapids, Mich. received its third re-accreditation based on the results of recent onsite inspections.  In May of 2011, laboratory director Daniel H. Farkas, Ph.D., H.C.L.D. was advised of this national recognition and congratulated for the excellence of the services being provided, making the laboratory one of more than 7,000 CAP-accredited facilities worldwide. 

About Sequenom

Sequenom, Inc. (NASDAQ:SQNM - News) is a life sciences company committed to improving healthcare through revolutionary 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 Center for Molecular Medicine

Sequenom Center for Molecular Medicine (Sequenom CMM®) is a CAP accredited and CLIA-certified molecular diagnostics laboratory dedicated to the development and commercialization of laboratory-developed genetic tests for prenatal and ophthalmic conditions. Utilizing innovative proprietary technologies, Sequenom CMM provides test results that can be used as tools by clinicians in managing patient care. Testing services are available only upon request by physicians. Sequenom CMM scientists work closely with key opinion leaders and experts in obstetrics, retinal care and genetics. Our scientists use a variety of sophisticated and cutting-edge methodologies in the development and validation of tests. Sequenom CMM is helping to advance patient care with the power of molecular diagnostics. Visit www.SequenomCMM.com for more information on laboratory services.

About Silicon Valley Bank

Silicon Valley Bank provides commercial banking services to emerging growth and mature companies in the technology, life science, venture capital, private equity and premium wine industries. Through its focus on specialized markets and extensive knowledge of the people and business issues driving them, Silicon Valley Bank provides a level of service and partnership that measurably impacts its clients' success. Founded in 1983 and headquartered in Santa Clara, Calif., the company serves clients around the world through 26 U.S. offices and seven international operations. Silicon Valley Bank is a member of global financial services firm SVB Financial Group (Nasdaq:SIVB - News).  More information on the company can be found at www.svb.com.

Banking services are provided by Silicon Valley Bank, a member of the FDIC and the Federal Reserve System. SVB Financial Group is also a member of the Federal Reserve System.

Forward-Looking Statements

Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the use of proceeds from the credit facility, the commercialization and launch of new laboratory developed tests, the effect or impact of the credit facility on extending the runway provided to Sequenom by financings in the past and on Sequenom's ability to maintain a consistent level of liquidity in the future as it moves into an active growth phase, Sequenom's commitment to improving healthcare through revolutionary genetic analysis solutions and dedication to development and commercialization of laboratory-developed genetic tests for prenatal and ophthalmic conditions, 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 other parties, Sequenom's ability to develop and commercialize new technologies and products, particularly new technologies such as 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 and investigations and other risks detailed from time to time in Sequenom, Inc.'s most recent Annual Report on Form 10-K 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, Inc. undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.


"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

Stock price continues to show unusual strength...
with the  market being down.
If Sequenom reaches 8.65 on a close or higher...
stock price is off to the races to the $13.00 to $15.00 range.
There can and probably will be zig zags to get there but the point and figure chart has confirmed the $15.00 target price.

Day's Range: 8.17 - 8.71
52wk Range: 5.25 - 8.71
Volume: 6,333,643
Avg Vol (3m): 2,152,450
Market Cap: 845.95M

Technicals
Record Price High
Most Actives
Percentage Gainer

Last Price Quote is:
8.18%above 13-day EMA
15.65%above 50-day EMA
RS Rating: 98  

Resistance... $8.88
Support... $8.21...$7.97...$7.68

Recent CandleStick Analysis
Bullish

Date              Candle
Jun-02-2011  Bullish Engulfing  

"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis