FDA Clears NG Sequencing Devices

More than 10 million Americans carry Cystic Fibrosis (CF) and in the U.S. alone 30,000 children and adults are affected with CF. Most children with CF are diagnosed by age 2 and live to be 37 which is the average life span for people with CF.

FDA’s first regulatory clearance of high-throughput DNA sequencing devices will help healthcare professionals use unique genetic information to provide more information on not only CF but other diseases.

The two newly cleared sequencing devices that can now be used to detect DNA changes in the CF Transmembrane Conductance Regulator (CFTR) gene which may result in CF are:

  • The Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay able to check specific points in the patient’s CFTR gene sequence to detect known variants in the gene. Information on DNA changes that are associate with symptoms of CF are found in the Clinical and Functional Translation of CFTR database.
  • The Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay able to sequence a large portion of the CFTR gene to detect any difference in the CFTR gene

 

FDA also granted de novo petitions for the Illumina MiSeqDX instrument platform and for the Illumina Universal Kit reagents. These two devices make up the first FDA-regulated test system to enable laboratories to develop and validate sequencing of any part of a patient’s genome. The Universal Kit reagents isolate and create copies of genes that can be obtained from the patient’s blood sample.

According to Francis S. Collins, M.D., PhD, “The availability of high throughput DNA sequencers will enable physicians to take a comprehensive look at a patient’s genetic blue print or genome to search for a wide range of variations or changes that may increase the risk for disease and then drive the process that may affect response to medications and other treatments. Such information has the potential to benefit patients in many ways. For example, an oncologist could use the results of a sequencing scan to choose the chemotherapy drug that is most likely to work.”