(Nov. 7, 2013)
Dr. Harry Hixson - Chairman and Chief Executive Officer
"I would like to add that we are – we’re looking at a number of other instrument platforms in addition to the one that we have now and we hope to have some things to say about that in future calls."
8. HH is 182,000 in line
("200,000 people apply to live on Mars", By Elizabeth Landau, CNN
updated 5:06 PM EST, Tue December 10, 2013 )
The lawsuit by San Diego resident Lisa Casey alleges that the test results are "meaningless."
According to the complaint, which seeks at least $5 million under various California state laws, 23andMe makes false and misleading claims about the tests’ ability to provide relevant genetic information about breast cancer, diabetes, lactose intolerance and various other conditions.
...... of the Chinese announcement on Saturday that it was establishing an “air defense identification zone” over contested islands and seas that have been the source of increasing tension with Japan.
But the message was clear."
FDA NEWS RELEASE
For Immediate Release: Nov. 19, 2013
Media Inquiries: Susan Laine, 301-796-5349, email@example.com
Consumer Inquiries: 888-INFO-FDA
FDA allows marketing of four “next generation” gene sequencing devices
Two devices aid in screening and diagnosis of cystic fibrosis
Today the U.S. Food and Drug Administration allowed marketing of four diagnostic devices that can be used for high throughput gene sequencing, often referred to as “next generation sequencing” (NGS). These instruments, reagents, and test systems allow labs to sequence a patient’s DNA (deoxyribonucleic acid).
The new technology also gives physicians the ability to take a broader look at their patients’ genetic makeup and can help in diagnosing disease or identifying the cause of symptoms.
“NGS is changing the way we look at genomics,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health. “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.”
Two of the newly cleared devices are used to detect DNA changes in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, which can result in cystic fibrosis (CF), an inherited chronic disease that affects the lungs, pancreas, liver, intestines, and other organs of those who inherit a faulty CFTR gene from both parents.
More than 10 million Americans are CF carriers and approximately 30,000 children and adults in the U.S. are affected with CF. Most children with CF are diagnosed by age 2 and the average life span for people with CF who live to adulthood is approximately 37 years.
The cleared devices include:
The Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay, which checks specific points in the patient’s CFTR gene sequence to detect known variants in the gene. Information about which DNA changes are associated with symptoms of cystic fibrosis is found in the Clinical and Functional TRanslation of CFTR database (CFTR2 disclaimer icon ).
The Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, which sequences a large portion of the CFTR gene to detect any difference in the CFTR gene compared to a reference CFTR gene.
Data submitted by Illumina for their cystic fibrosis tests included comparisons of the sequence results to Human Genome Build 19, a reference representation of the human genome. In addition, Illumina evaluated the performance of its instrument and reagent systems against a publically available quality-weighted human reference genome that was created through collaboration between the FDA and the National Institutes of Standards and Technology (NIST).
FDA authorized sequencing devices provide labs with quality and performance information
The FDA also granted de novo petitions for the Illumina MiSeqDx instrument platform and the Illumina Universal Kit reagents, two devices that make up the first FDA-regulated test system that allows laboratories to develop and validate sequencing of any part of a patient’s genome. The Universal Kit reagents isolate and create copies of genes of interest obtained from patient blood samples, and the MiSeqDx platform analyzes the genes. The software compares the patient’s genomic sequence to a reference sequence and reports back any differences between the patient and the reference.
“The FDA’s review of the MiSeqDx and sequencer and Universal Kit reagents provides clinical laboratories with information about the expected performance of the device and the quality of the results,” said Dr. Gutierrez. “This information was not previously available for next generation sequencers, and, with this platform, labs can develop tests for clinical use with greater confidence because they use FDA authorized devices.”
The FDA reviewed the Illumina MiSeqDx instrument platform and the Illumina Universal Kit reagents through its de novo classification process, a regulatory pathway for some novel low-to-moderate risk medical devices that are not substantially equivalent to an already legally marketed device.
For the de novo petitions, the FDA based its decision on the demonstrated performance of the MiSeqDx instrument and Universal Kit reagent systems across numerous genomic segments spanning 19 human chromosomes.
Illumina MiSeqDx instrument platform, Universal Kit reagents, MiSeqDx Cystic Fibrosis 139-Variant Assay, and MiSeqDx Cystic Fibrosis Clinical Sequencing Assay are manufactured by Illumina, Inc. in San Diego, Calif.
Illumina, Inc. (NASDAQ:ILMN) today announced that it received premarket clearance from the U.S. Food and Drug Administration (FDA) for the MiSeqDx system, the first high-throughput DNA sequencing analyzer to receive FDA clearance. Illumina also received FDA premarket clearance for the MiSeqDx Cystic Fibrosis 139-Variant Assay, MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, and MiSeqDx Universal Kit.
The MiSeqDx benchtop sequencer offers users the ability to run diagnostic or research applications on a single, easy-to-use system. Designed and validated for the clinical market, the MiSeqDx with the portfolio of FDA-cleared in vitro diagnostic kits and assays leverage Illumina's sequencing by synthesis (SBS) chemistry for high confidence in results.
The MiSeqDx Cystic Fibrosis 139-Variant Assay is designed for simultaneous detection of 139 clinically relevant disease-causing mutations and variants within the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The assay includes all cystic fibrosis-causing variants recommended for carrier screening purposes by the American College of Medical Genetics and Genomics (ACMG) and the American College of Obstetricians and Gynecologists (ACOG).
The MiSeqDx Cystic Fibrosis Clinical Sequencing Assay leverages Illumina's targeted resequencing chemistry to provide highly accurate sequencing data for the protein coding regions and intron/exon boundaries of the CFTR gene.
The MiSeqDx Universal Kit enables clinical laboratories to develop their own diagnostic tests. The kit includes library preparation reagents, sample index primers, and sequencing consumables needed for laboratories to develop amplicon assays on the in vitro diagnostic platform.
"Illumina is proud to be the first company to obtain FDA clearance for a high-throughput DNA sequencing analyzer and next-generation sequencing-based assays," said Greg Heath, Senior Vice President and General Manager of Illumina's Diagnostics business. "With the FDA clearance of the MiSeqDx, Illumina is providing clinicians and clinical laboratories with the tools needed to obtain comprehensive and reliable results from a DNA sequencing analyzer and enabling them to create and deploy NGS-based molecular diagnostic tests for cystic fibrosis and a wide-range of other applications."
The MiSeqDx, MiSeqDx Cystic Fibrosis 139-Variant Assay, MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, and MiSeqDx Universal Kit are now available for immediate order with shipment before the end of 2013 in the United States and Europe.
Nov.11, Sequenom reiterated at Buy at Maxim, Price target is $6
"Noninvasive detection of cancer-associated genome-wide hypomethylation and copy number aberrations by plasma DNA bisulfite sequencing"