Illumina (NASDAQ: ILMN) got marketing authorization from the U.S. Food and Drug Administration for its diagnostic devices for next generation gene sequencing or NGS. Two of the devices focus on a gene associated with cystic fibrosis. More than 10 million people carry the cystic fibrosis transmembrane conductance regulator gene, according to an FDA statement.
The diagnostic will screen for a wide number of variations in the CFTCR gene, Elizabeth Mansfield, director of personalized medicine in the FDA’s medical-device center, told The Wall Street Journal.
The FDA also granted the company’s DeNovo petition for its MiSeqDx Universal Kit. The kit is designed to help clinical labs develop their own diagnostic tests on an in vitro diagnostic platform. The DeNovo petition approval means that the classification changes from a Class 3 to a Class 2 or Class 1 device.
A New England Journal of Medicine editorial sought to put the FDA’s move in perspective:
“Clinicians can selectively look for an almost unlimited number of genetic changes that may be of medical significance. Access to these data opens the door for the transformation of research, clinical care, and patient engagement.”
Cystic fibrosis can affect the lungs, pancreas, liver, intestines and other organs. It affects people who inherit the gene from both parents. More than 10 million people in the U.S. are cystic fibrosis carriers, while about 30,000 children and adults have the condition. The life expectancy for people with cystic fibrosis is 37 years.
There’s currently no cure for cystic fibrosis. What makes the FDA’s move to green-light the devices significant is it will provide a way for parents to find out if they both carry the gene. It could also help people get a diagnosis earlier.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Alberto Gutierrez, the director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said: “Before NGS, sequencing genes associated with a particular disease was a long and costly process. Today, we have the capability to read and interpret large segments of DNA very quickly in a single test and this information-rich technology is becoming more accessible for use by physicians in the care of their patients.”
The next generation sequencing market is projected to grow to $7.6 billion by 2018, according to BCC Research.
