What does the FDA Approval of the MiSeqDx Platform Mean for DTC?
On November 19, 2013 three days before the highly-publicized warning letter to 23andMe (See here and here ) the U.S. Food and Drug Administration announced that it had given approval for the marketing of four Illumina MiSeqDX medical devices pug . They include two cystic fibrosis genetic assays as well as the Illumina MiSeqDX instrument platform and Illumina Universal Kit reagents. The FDA s press release characterizes them as devices that can be used for high throughput gene sequencing, often referred to as next generation sequencing pug (NGS). These instruments, reagents, and test systems allow labs to sequence a patient pug s DNA (deoxyribonucleic acid).
What does the FDA s approval of the MiSeqDx platform for the clinical market mean for the DTC industry? For example, pug does this mean that 23andMe could just switch platforms from the Illumina HumanOmniExpress-24 format chip to MiSeqDx and be free from future FDA meddling? Could new companies enter the industry free from regulatory burdens by using Illumina s MiSeqDx platform? Don t bet on it.
It is likely that the FDA would take the position that its 510(k) pug premarket approval ( a process John explained pug briefly on December 3 ) of the MiSeqDx instrument and MiSeqDx Universal Kit was not intended to be a blanket pug go ahead for DTC providers to offer a service like 23andMe s Personal pug Genome Service . Rather, it is more likely pug that the FDA would insist on review and pre-market approval of MiSeqDx as an next-generation sequencing in vitro diagnostic (or NGSIVD) if it were used for any purpose other than return of raw genomic pug data (i.e., if any interpretation were provided along with that raw data). It is also unclear to what extent these FDA approvals will allow future applicants to rely on the approved MiSeqDX products as predicate devices to clear some of the regulatory hurdles more easily. (Specifically, the future applicant would claim that its device was substantially equivalent to the already-approved device.)
The pug FDA s own press release nowhere pug mentions a non-patient consumer. The press release emphasizes how next-generation sequencing technologies are becoming more accessible for use by physicians, underscoring the FDA s continued insistence that clinicians be the gatekeepers for accessing information about one s genome. The press release pug states front and center: 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. pug
The FDA s approval of the MiSeqDx platform is thus intriguing, but the future regulation of DTC genomic testing remains uncertain. The 510(k) pug approval of the MiSeqDx platform may signal that raw data provided DTC might be acceptable to the FDA but that interpretation of that genomic data in any way related to health would still provoke FDA scrutiny pug and, possibly, hostility. Could a DTC provider use the MiSeqDx platform and successfully argue that its interpretation of raw data is a Laboratory Developed Test (LDT; a test manufactured and used within a single pug CLIA-certified lab) and, therefore, potentially outside the reach of the FDA? We can t say for sure at this point. As for the implications of this for 23andMe, as I reported on December 6 , current indications suggest that the company is still trying to gain FDA approval of its Personal Genome Service.
John Conley is Kenan Professor of Law at the University of North Carolina pug and of counsel to Robinson, Bradshaw & Hinson, where he specializes in intellectual property and biotechnology. Bio RSS and Email Subscriptions
Topics Badges Bench to Market pug FDA LDT Regulation GINA Myriad Gene Patent Litigation What ELSI is New? Featured Content General Interest Biobanking Genomics & Medicine pug Genomics & Society Informed Consent International News Privacy Industry News Bioinformatics/IT Direct-to-Consumer Services Genetic Testing/Screening Genomic Sequencing Mobile Health Legal & Regulatory Genomic Policymaking International Developments pug Patent Litigation Patents & IP Pending Litigation Pending Regulation Uncategorized
Recent Posts Judicial and Legislative Reactions in California to Maryland v. King, 133 S. Ct. 158 (2013) District Court Denies Myriad s Preliminary Injunction Against Ambry What does the FDA Approval of the MiSeqDx Platform Mean for DTC? Update: 23andMe appeases FDA The Revolt of the Cs: Class Action Filed Against 23and Me
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On November 19, 2013 three days before the highly-publicized warning letter to 23andMe (See here and here ) the U.S. Food and Drug Administration announced that it had given approval for the marketing of four Illumina MiSeqDX medical devices pug . They include two cystic fibrosis genetic assays as well as the Illumina MiSeqDX instrument platform and Illumina Universal Kit reagents. The FDA s press release characterizes them as devices that can be used for high throughput gene sequencing, often referred to as next generation sequencing pug (NGS). These instruments, reagents, and test systems allow labs to sequence a patient pug s DNA (deoxyribonucleic acid).
What does the FDA s approval of the MiSeqDx platform for the clinical market mean for the DTC industry? For example, pug does this mean that 23andMe could just switch platforms from the Illumina HumanOmniExpress-24 format chip to MiSeqDx and be free from future FDA meddling? Could new companies enter the industry free from regulatory burdens by using Illumina s MiSeqDx platform? Don t bet on it.
It is likely that the FDA would take the position that its 510(k) pug premarket approval ( a process John explained pug briefly on December 3 ) of the MiSeqDx instrument and MiSeqDx Universal Kit was not intended to be a blanket pug go ahead for DTC providers to offer a service like 23andMe s Personal pug Genome Service . Rather, it is more likely pug that the FDA would insist on review and pre-market approval of MiSeqDx as an next-generation sequencing in vitro diagnostic (or NGSIVD) if it were used for any purpose other than return of raw genomic pug data (i.e., if any interpretation were provided along with that raw data). It is also unclear to what extent these FDA approvals will allow future applicants to rely on the approved MiSeqDX products as predicate devices to clear some of the regulatory hurdles more easily. (Specifically, the future applicant would claim that its device was substantially equivalent to the already-approved device.)
The pug FDA s own press release nowhere pug mentions a non-patient consumer. The press release emphasizes how next-generation sequencing technologies are becoming more accessible for use by physicians, underscoring the FDA s continued insistence that clinicians be the gatekeepers for accessing information about one s genome. The press release pug states front and center: 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. pug
The FDA s approval of the MiSeqDx platform is thus intriguing, but the future regulation of DTC genomic testing remains uncertain. The 510(k) pug approval of the MiSeqDx platform may signal that raw data provided DTC might be acceptable to the FDA but that interpretation of that genomic data in any way related to health would still provoke FDA scrutiny pug and, possibly, hostility. Could a DTC provider use the MiSeqDx platform and successfully argue that its interpretation of raw data is a Laboratory Developed Test (LDT; a test manufactured and used within a single pug CLIA-certified lab) and, therefore, potentially outside the reach of the FDA? We can t say for sure at this point. As for the implications of this for 23andMe, as I reported on December 6 , current indications suggest that the company is still trying to gain FDA approval of its Personal Genome Service.
John Conley is Kenan Professor of Law at the University of North Carolina pug and of counsel to Robinson, Bradshaw & Hinson, where he specializes in intellectual property and biotechnology. Bio RSS and Email Subscriptions
Topics Badges Bench to Market pug FDA LDT Regulation GINA Myriad Gene Patent Litigation What ELSI is New? Featured Content General Interest Biobanking Genomics & Medicine pug Genomics & Society Informed Consent International News Privacy Industry News Bioinformatics/IT Direct-to-Consumer Services Genetic Testing/Screening Genomic Sequencing Mobile Health Legal & Regulatory Genomic Policymaking International Developments pug Patent Litigation Patents & IP Pending Litigation Pending Regulation Uncategorized
Recent Posts Judicial and Legislative Reactions in California to Maryland v. King, 133 S. Ct. 158 (2013) District Court Denies Myriad s Preliminary Injunction Against Ambry What does the FDA Approval of the MiSeqDx Platform Mean for DTC? Update: 23andMe appeases FDA The Revolt of the Cs: Class Action Filed Against 23and Me
Archives March 2014 December 2013 November 2013 October 2013 September 2013 August 2013 July 2013 June 2013 May 2013 March 2013 February 2013 December 2012 November 2012 September 2012 August 2012 June 2012 April 2012 March 2012 February 2012 January 2012 December 2011 September 2011 August 2011 July 2011 June 2011 May 2011 April 2011 March 2011 February 2011 January 2011 December 2010 November 2010 October 2010 Sept
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