Devices & Diagnostics

Genetic analysis firm Sequenom selects RTP for molecular diagnostics unit

Genetic analysis company Sequenom (NASDAQ:SQNM) has chosen Research Triangle Park, North Carolina to build up its newer molecular diagnostics unit, which the company expects could become its biggest business. The Sequenom Center for Molecular Medicine is set to open in the second half of 2012 and will focus on developing diagnostics for prenatal diseases and […]

Genetic analysis company Sequenom (NASDAQ:SQNM) has chosen Research Triangle Park, North Carolina to build up its newer molecular diagnostics unit, which the company expects could become its biggest business.

The Sequenom Center for Molecular Medicine is set to open in the second half of 2012 and will focus on developing diagnostics for prenatal diseases and conditions. The lab’s first product will be a Down’s syndrome diagnostic that tests for the genetic disorder through a blood test.

Paul Maier, president of the Sequenom Center for Molecular Medicine, said that Sequenom’s genetic analysis is more accurate than existing testing methods, less invasive and less risky. While amniocentesis provides accurate test results, its risks include miscarriage. In contrast, Sequenom’s Materniti21 test can analyze a fetus’ DNA with only a small amount of the mother’s blood.

“We take a blood sample as early as 10 weeks of pregnancy and we can detect whether there is this chromosomal abnormality,” Maier said.

Molecular diagnostics is a relatively new business for Sequenom, which was founded in 1994. The company’s main business is selling genetic analysis instruments used primarily for research on the human genome. That business generated more than $42.4 million of the company’s $47.4 million 2010 revenue. Sequenom got into the business of molecular diagnostics two years ago. The company now has two prenatal tests, one for cystic fibrosis and another for rhesus factor disease, a blood disorder. Sequenom also has a genetic test for age-related macular degeneration. The technology for the Materniti21 test was licensed from Oxford University.

Maier further explains Sequenom’s molecular diagnostics technology in this video:

Sequenom expects the Down’s syndrome test will become big business. The company aims for the test to be used in high-risk pregnancies, which Maier says are pregnancies in women age 35 or older or in those with a family history of Down’s syndrome. Maier said there are an estimated 750,000 such high-risk pregnancies in the United States each year.

The North Carolina lab will test blood samples sent from clinicians. While the laboratory test does not need Food and Drug Administration clearance, Maier said Sequenom is talking with regulators about what clinical studies they would like the company to do. The test will launch sometime in the fourth quarter to coincide with publication of a report in a peer-reviewed journal. Maier said he expects the test will be covered by insurance.

North Carolina’s Research Triangle will become the focus of much of Sequenom’s growth and the company projects a capital investment of $18.7 million for its new RTP lab. The facility will employ about 240 people – nearly double Sequenom’s current workforce. Sequenom is receiving state incentives. North Carolina economic development officials awarded the company a Job Development Investment Grant, an incentive for new and expanding businesses in the state. The grant is worth up to $2.3 million if Sequenom meets job creation targets over nine years.