Sequenom Laboratories announces launch of MaterniT GENOME test

Sequenom, Inc.Jul 13 2015

Sequenom Laboratories, a wholly owned subsidiary of Sequenom, Inc. (NASDAQ: SQNM), a life sciences company committed to enabling healthier lives through the development of innovative products and services, announced today the upcoming launch of the MaterniT™ GENOME laboratory-developed test. This test is the first noninvasive prenatal test (NIPT) to provide karyotype-level insight into fetal chromosomal status prior to considering an invasive procedure. The MaterniT GENOME test adds genome-wide identification of chromosomal gains or losses greater than 7 megabases (Mb) in size to Sequenom Laboratories' growing NIPT testing portfolio.

"While cell-free DNA screening has marked a significant improvement in identifying pregnancies at risk for select whole chromosome aneuploidies, there remain a number of significant cytogenetic abnormalities that noninvasive prenatal testing has not been able to identify," said Ronald Wapner, M.D., Director of Reproductive Genetics at Columbia University Medical Center. "The ability to noninvasively detect subchromosomal alterations 7 megabases or greater throughout the genome should identify the majority of these changes that were previously undetectable by NIPT."

The MaterniT GENOME test builds upon the industry leading microdeletion performance demonstrated by Sequenom Laboratories with the MaterniT21 PLUS laboratory-developed test, which was recently highlighted in an article by Hume JH, et al, published in the peer-reviewed journal Prenatal Diagnosis. Data supporting the validation of the MaterniT GENOME test will be presented at the 19^th International Conference on Prenatal Diagnosis and Treatment (sponsored by the International Society of Prenatal Diagnosis and Therapy - ISPD) in Washington D.C., taking place July 12-15, 2015. The MaterniT GENOME test will be available to physicians later this quarter.

"The MaterniT GENOME test fulfills our goal of delivering the most relevant fetal genomic information noninvasively," said William Welch, President and Chief Executive Officer of Sequenom. "As pioneers and innovators in noninvasive prenatal testing, we believe MaterniT GENOME represents a safe, cost effective and meaningful breakthrough in NIPT, supporting physicians in providing superior prenatal care for their patients."

Sequenom Laboratories offers the most comprehensive portfolio of noninvasive prenatal testing services, including the VisibiliT™ and MaterniT21 PLUS tests, in addition to the new MaterniT GENOME test.

Sequenom Laboratories Scientific Posters at ISPD

Sequenom Laboratories is featuring four posters at ISPD; three posters showcasing recent research and clinical applications associated with the MaterniT21 PLUS test, and one poster supporting the new MaterniT GENOME test. The poster session will take place on Tuesday, July 14, 2015, from 1:15 – 2:00 p.m. ET.

• Poster #P2-1 – Clinical experience of trisomy 16 and 22, and microdeletion detection by noninvasive prenatal testing (NIPT)
• Poster #P2-2 – High volume clinical laboratory noninvasive prenatal testing: results from >400,000 patients
• Poster #P2-8 – Leveraging targeted sequencing of paired homologs for noninvasive detection of fetal aneuploidies
• Poster #P2-37 – Karyotype-level noninvasive prenatal testing by sequencing of circulating cell-free DNA from maternal plasma