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AACC expresses concerns to FDA regarding overregulation of next-generation sequencing tests

The American Association for Clinical Chemistry wrote a formal request letter to the FDA expressing concern about the potential overregulation of next-generation sequencing tests, the association said in a press release.
The letter was written in response to FDA’s preliminary discussion paper on next-generation sequencing (NGS) titled “Optimizing FDA’s Regulatory Oversight of Next-Generation Sequencing Diagnostic Tests.”

In its paper, the FDA defined an NGS test as “a human DNA sequencing assay performed on a particular NGS instrument (eg, MiSeqDx, [Illumina]) with a workflow defined by standard operating procedures that specify all materials and procedures.”

The FDA’s paper sought public input on the issue of implementing new regulatory approaches.

“In this request for public input, FDA is considering new regulatory approaches only for NGS tests because this technology allows broad and indication-blind testing and is capable of generating vast amounts of data, both of which present issues that traditional regulatory approaches are not well-suited to address,” the FDA wrote. “Other technologies capable of detecting genetic variation, including but not limited to [polymerase chain reaction] and [single nucleotide polymorphism] arrays, are generally designed to capture predefined data points that are known in advance of testing, and therefore are more suited to regulation under traditional approaches.”

In its comments, the American Association for Clinical Chemistry (AACC) maintained that oversight of NGS diagnostic tests — like other laboratory-developed tests — should remain under the Clinical Laboratory Improvement Amendments (CLIA). According to the AACC, CLIA-regulated laboratories have the experience developing, verifying and performing clinical tests that is needed to conduct NGS. The AACC cautioned the FDA against “overregulating” these important genetic tests.

“AACC agrees with the FDA that next-generation sequencing tests offer great opportunities for advancing laboratory medicine and improving patient care, and we commend the agency's efforts to initiate a dialogue among the various organizations and professionals involved in next-generation sequencing and those affected by such testing,” David D. Koch, PhD, AACC president, said. “We believe, however, that the current oversight mechanisms in place for [NGS] are sufficient for dealing with the particular challenges this technology presents and that further FDA involvement at this time might hinder the advancement of this field.”

In its comment letter, the AACC wrote that although NGS is a fairly new technology, best practice and guidance documents have been developed to help laboratories navigate this new territory. For example, the College of American Pathologists has developed a specific checklist for laboratory inspections of facilities performing clinical NGS tests, and has also created a proficiency testing program.

“Although high throughput NGS is a relatively new type of laboratory developed test, CLIA-regulated laboratories conducting NGS testing are experienced in developing, verifying and performing laboratory-developed tests,” the AACC letter reads. “Furthermore, professional organizations provide laboratories with guidance on how to perform, ensure the quality, and verify the accuracy of NGS tests.” – by Jen Byrne

References:

FDA. Letter. Available at: www.aacc.org/~/media/files/legislative-issues/2015/ngs_comments.pdf?la=en. Accessed on March 18, 2015.

FDA. Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests — Preliminary Discussion Paper. Available at: www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM427869.pdf. Accessed on March 18, 2015.

The American Association for Clinical Chemistry wrote a formal request letter to the FDA expressing concern about the potential overregulation of next-generation sequencing tests, the association said in a press release.
The letter was written in response to FDA’s preliminary discussion paper on next-generation sequencing (NGS) titled “Optimizing FDA’s Regulatory Oversight of Next-Generation Sequencing Diagnostic Tests.”

In its paper, the FDA defined an NGS test as “a human DNA sequencing assay performed on a particular NGS instrument (eg, MiSeqDx, [Illumina]) with a workflow defined by standard operating procedures that specify all materials and procedures.”

The FDA’s paper sought public input on the issue of implementing new regulatory approaches.

“In this request for public input, FDA is considering new regulatory approaches only for NGS tests because this technology allows broad and indication-blind testing and is capable of generating vast amounts of data, both of which present issues that traditional regulatory approaches are not well-suited to address,” the FDA wrote. “Other technologies capable of detecting genetic variation, including but not limited to [polymerase chain reaction] and [single nucleotide polymorphism] arrays, are generally designed to capture predefined data points that are known in advance of testing, and therefore are more suited to regulation under traditional approaches.”

In its comments, the American Association for Clinical Chemistry (AACC) maintained that oversight of NGS diagnostic tests — like other laboratory-developed tests — should remain under the Clinical Laboratory Improvement Amendments (CLIA). According to the AACC, CLIA-regulated laboratories have the experience developing, verifying and performing clinical tests that is needed to conduct NGS. The AACC cautioned the FDA against “overregulating” these important genetic tests.

“AACC agrees with the FDA that next-generation sequencing tests offer great opportunities for advancing laboratory medicine and improving patient care, and we commend the agency's efforts to initiate a dialogue among the various organizations and professionals involved in next-generation sequencing and those affected by such testing,” David D. Koch, PhD, AACC president, said. “We believe, however, that the current oversight mechanisms in place for [NGS] are sufficient for dealing with the particular challenges this technology presents and that further FDA involvement at this time might hinder the advancement of this field.”

In its comment letter, the AACC wrote that although NGS is a fairly new technology, best practice and guidance documents have been developed to help laboratories navigate this new territory. For example, the College of American Pathologists has developed a specific checklist for laboratory inspections of facilities performing clinical NGS tests, and has also created a proficiency testing program.

“Although high throughput NGS is a relatively new type of laboratory developed test, CLIA-regulated laboratories conducting NGS testing are experienced in developing, verifying and performing laboratory-developed tests,” the AACC letter reads. “Furthermore, professional organizations provide laboratories with guidance on how to perform, ensure the quality, and verify the accuracy of NGS tests.” – by Jen Byrne

References:

FDA. Letter. Available at: www.aacc.org/~/media/files/legislative-issues/2015/ngs_comments.pdf?la=en. Accessed on March 18, 2015.

FDA. Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests — Preliminary Discussion Paper. Available at: www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM427869.pdf. Accessed on March 18, 2015.