Sequenom Laboratories and Quest Diagnostics Collaborate to Expand Patient Access to the MaterniT21™ PLUS Noninvasive Prenatal Test

MADISON, N.J. and SAN DIEGO, June 16, 2014 /PRNewswire/ -- Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative genetic analysis solutions, and Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services, today announced an agreement under which Quest will offer national access to Sequenom Laboratories' MaterniT21 PLUS laboratory-developed test (LDT). Using a maternal blood sample, the noninvasive prenatal test (NIPT) analyzes chromosomal material in cell-free fetal DNA of pregnant women at increased risk for fetal chromosomal abnormalities. Quest expects to begin offering access to the test in the third quarter.

In addition, Quest has formed a license agreement with Sequenom for certain NIPT patents and patent applications. The license agreement is the first formed by Sequenom with a commercial lab in the United States. Quest intends to use the intellectual property for the purposes of developing and validating its own proprietary lab-developed NIPT test. Quest expects to introduce this new offering in 2015. Additional terms of the agreement were not disclosed.

"Noninvasive prenatal testing is one of the most promising new areas of medicine because it delivers highly actionable insights for empowering critical health decisions," said Charles (Buck) Strom, MD, PhD, Senior Medical Director, Genetics, Quest Diagnostics. "The MaterniT21 PLUS test stands out for its technological sophistication and clinical usefulness, and is the most well validated to date of the NIPT offerings. Offering access to this test strongly aligns with our strategy to deliver guideline-backed testing services based on the most advanced technologies in order to improve healthcare for patients."

A December 2012 medical opinion from the American Congress of Obstetricians and Gynecologists (ACOG) and the Society of Maternal Fetal Medicine (SMFM) supports the use of cell-free fetal DNA testing as an option for primary screening for women at increased risk of aneuploidy (abnormal chromosomal number), including those 35 years of age or older or who have a history of ultrasound abnormalities in pregnancy.

"We are pleased to establish a nationwide partnership with Quest, the world's leading provider of diagnostic information services," said William Welch, Chief Executive Officer of Sequenom, Inc. "Quest is a superb partner to further extend access to our MaterniT21 PLUS test to physicians and their patients seeking to make the most well informed decisions possible."

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 select other chromosomal material and micro deletions and duplications in cell-free DNA.  The MaterniT21 PLUS test may be used for pregnant women at increased risk for fetal chromosomal abnormalities. 

Once available, physicians will be able to order the test through Quest Diagnostics, which will forward specimens for testing to Sequenom Laboratories.

Estimates suggest about 750,000 pregnancies may be at high risk for fetal chromosomal abnormalities each year in the United States.

Quest Diagnostics Women's Health Services
Quest Diagnostics is provider of comprehensive diagnostic information services for women's health disorders across the continuum of a woman's life. The company's specialized services feature one of the broadest menus of genetic services for pregnancy, including carrier screening for spinal muscular atrophy, cystic fibrosis and fragile X syndrome. The company also provides diagnostic information services for cervical, breast and ovarian cancer, and sexually transmitted diseases and reproductive tract infections. In addition, Quest Diagnostics provides genetic counseling services for clinicians and parents and publishes original research on women's health issues in peer-reviewed journals and at scientific conferences.

About Quest Diagnostics
Quest Diagnostics is the world's leading provider of diagnostic information services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic information services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at QuestDiagnostics.com. Follow us at Facebook.com/QuestDiagnostics and Twitter.com/QuestDX.

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 molecular diagnostic markets. Web site: www.sequenom.com.

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, performed exclusively by Sequenom Laboratories, 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 and Quest Diagnostics' expectations related to future performance under the agreements between Sequenom and Quest Diagnostics, the expected or potential benefits and impact of those agreements on Sequenom, patients and physicians, expected expansion of patient access to the MaterniT21 PLUS test and the expected availability and timing of Quest Diagnostics' offering access to the test, Quest Diagnostics' intentions, plans, and strategy based on the agreements, Sequenom's commitment to improving healthcare through revolutionary genomic and genetic analysis solutions, and Sequenom Laboratories' changing the landscape in genetic disorder diagnostics, 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 Quest Diagnostics, healthcare providers and others, Sequenom or third parties obtaining or maintaining regulatory approvals that impact Sequenom's business, government regulation particularly with respect to diagnostic products and laboratory developed tests, publication processes, the performance of designed product enhancements, Sequenom's ability to develop and commercialize technologies and products, particularly new technologies such as noninvasive prenatal diagnostics and laboratory developed tests, Sequenom's financial position, the timing and amount of reimbursement that Sequenom Laboratories receives from payors for its 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, litigation involving Sequenom, and other risks detailed from time to time in Sequenom's most recently filed reports on Form 8-K, its most recently filed Quarterly Report on Form 10-Q and its Annual Report on Form 10-K/A and 10-K for the year ended December 31, 2013, 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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SOURCE Sequenom, Inc.



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