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U.S. Department of Health and Human Services

Medical Devices

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Letter of Authorization: Emergency Use of GeneSTAT 2009 A/H1N1 Influenza Test

The information previously contained on these webpages were authorized under the 2009 H1N1 Influenza Emergency Use Authorizations (EUAs). As of June 23, 2010, the EUAs have been terminated and this information is no longer current.

December 9, 2009


Mark J. Rosenfeld, M.S., Ph.D.

Chief Science Advisor, DxNA, LLC

3879 S. River Road, Bldg. A

St. George, UT 84790


Dear Dr. Rosenfeld:

This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of the GeneSTAT 2009 A/H1N1 Influenza Test for the diagnosis of 2009 H1N1 influenza virus infection in patients with signs and symptoms of respiratory infection, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3), by CLIA High Complexity Laboratories, which are laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. §263a, to perform high complexity tests.

On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. §360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency under 42 U.S.C. §247d that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such an agent or agents - in this case, 2009 H1N1 influenza virus.[1] Pursuant to section 564(b) of the Act (21 U.S.C. §360bbb-3(b)), and on the basis of such determination, the Secretary of HHS then declared an emergency justifying the authorization of the emergency use of certain in vitro diagnostics for the detection of 2009 H1N1 influenza virus, subject to the terms of any authorization issued under 21 U.S.C. §360bbb-3(a).

Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. §360bbb-3(c)) are met, I am authorizing the emergency use of the GeneSTAT 2009 A/H1N1 Influenza Test (as described in the scope section of this letter (Section II)) for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection, subject to the terms of this authorization.

I. Criteria for Issuance of Authorization

I have concluded that the emergency use of the GeneSTAT 2009 A/H1N1 Influenza Test for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:

  1. The 2009 H1N1 influenza virus can cause influenza, a serious or life threatening disease or condition to humans infected by this virus;
  2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the GeneSTAT 2009 A/H1N1 Influenza Test may be effective for the diagnosis of 2009 H1N1 influenza virus infection, and that the known and potential benefits of the GeneSTAT 2009 A/H1N1 Influenza Test, when used in the diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and potential risks of such product; and
  3. There is no adequate, approved, and available alternative to the emergency use of the GeneSTAT 2009 A/H1N1 Influenza Test for the diagnosis of 2009 H1N1 influenza virus infection.[2]

II. Scope of Authorization

I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of the authorized GeneSTAT 2009 A/H1N1 Influenza Test for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.

The Authorized GeneSTAT 2009 A/H1N1 Influenza Test:

The GeneSTAT 2009 A/H1N1 Influenza Test is a reverse-transcription polymerase chain reaction assay for the in vitro qualitative detection of 2009 H1N1 influenza viral RNA in nasopharyngeal swabs or nasal swabs from patients with signs and symptoms of respiratory infection. The GeneSTAT 2009 A/H1N1 Influenza Test is to be used in combination with the Roche High Pure RNA Isolation Kit and the GeneSTAT Analytical Platform. The assay is composed of two principal steps: (1) extraction of RNA from patient specimens, (2) one-step reverse transcription and PCR amplification using fluorogenic probes for detection.

The GeneSTAT 2009 A/H1N1 Influenza Test includes the following primer and probe sets:

  • H1: a primer-probe set designed to detect the presence of the hemagglutinin gene specifically found in the 2009 H1N1 influenza A virus.
  • N1:a primer-probe set designed to detect the presence of the neuraminidase gene specifically found in the 2009 H1N1 influenza A virus.
  • MA: a primer-probe set designed to detect the presence of a well conserved region of the matrix gene found in both, seasonal human influenza A virus and 2009 H1N1 influenza A virus.
  • P28:a primer-probe set designed to detect the presence of the Caprine Arthritis-Encephalitis Virus core polypeptide p28 gene (Exogenous Reaction Control).

The GeneSTAT 2009 A/H1N1 Influenza Test also includes the following control materials:

  • Influenza A Matrix-Positive ControlSwab.
  • H1-Positive ControlSwab (2009 H1N1 specific).

The GeneSTAT 2009 A/H1N1 Influenza Test requires the following hardware with corresponding software:

  • GeneSTAT Analytical Platform.

The GeneSTAT 2009 A/H1N1 Influenza Test requires the use of the following additional reagents/materials:

  • GeneSTAT H1N1 Test Module.
  • GeneSTAT Sample Prep Vial.
  • Roche High Pure RNA Isolation Kit.

The above described GeneSTAT 2009 A/H1N1 Influenza Test, when labeled consistently with the labeling authorized by FDA, entitled GeneSTATTM 2009 A/H1N1 Influenza Test Package Insert, (see http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm), as may be revised with written permission of FDA, is authorized to be distributed to CLIA High Complexity Laboratories under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law.

The above described GeneSTAT 2009 A/H1N1 Influenza Test is authorized to be accompanied by the following information pertaining to the emergency use, which is authorized to be made available to healthcare providers and patients:

  • Fact Sheet for Healthcare Providers: Interpreting GeneSTAT 2009 A/H1N1 Influenza Test Results
  • Fact Sheet for Patients: Understanding the GeneSTAT 2009 A/H1N1 Influenza Test Results

 

As described in section IV below, DxNA, LLC, is also authorized to make available additional information relating to the emergency use of the authorized GeneSTAT 2009 A/H1N1 Influenza Test that is consistent with, and does not exceed, the terms of this letter of authorization.

I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized GeneSTAT 2009 A/H1N1 Influenza Test in the specified population, when used for diagnosis of 2009 H1N1 influenza virus infection, outweigh the known and potential risks of such a product.

I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized GeneSTAT 2009 A/H1N1 Influenza Test may be effective in the diagnosis of 2009 H1N1 influenza virus infection pursuant to section 564(c)(2)(A) of the Act. The FDA has reviewed the scientific information available including the information supporting the conclusions described in Section I above, and concludes that the authorized GeneSTAT 2009 A/H1N1 Influenza Test, when used to diagnose 2009 H1N1 influenza virus infection in the specified population, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.

The emergency use of the authorized GeneSTAT 2009 A/H1N1 Influenza Test under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the conditions of authorization set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS' determination under section 564(b)(1)(C) described above and the Secretary of HHS' corresponding declaration under section 564(b)(1), the GeneSTAT 2009 A/H1N1 Influenza Test described above is authorized to diagnose 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.

This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.

III. Waiver of Certain Requirements

I am waiving the following requirements for the GeneSTAT 2009 A/H1N1 Influenza Test during the duration of this emergency use authorization:

  • Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling, storage, and distribution of the GeneSTAT 2009 A/H1N1 Influenza Test.
  • Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 809.30, except for the intended use statement (21 CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5) and (8)), any appropriate limitations on the use of the device including information required under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12).

IV. Conditions of Authorization

Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:

DxNA, LLC

  1. DxNA, LLC will distribute the authorized GeneSTAT 2009 A/H1N1 Influenza Test with the authorized labeling, as may be revised with written permission of FDA, only to CLIA High Complexity Laboratories.
  2. DxNA, LLC will provide to the CLIA High Complexity Laboratories the authorized GeneSTAT 2009 A/H1N1 Influenza Test Fact Sheets for Healthcare Providers and the authorized GeneSTAT 2009 A/H1N1 Influenza Test Fact Sheets for Patients.
  3. DxNA, LLC will make available on its website the authorized GeneSTAT 2009 A/H1N1 Influenza TestFact Sheets for Healthcare Providers and the authorized GeneSTAT 2009 A/H1N1 Influenza Test Fact Sheets for Patients.
  4. DxNA, LLC will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.
  5. All advertising and promotional descriptive printed matter relating to the use of the authorized GeneSTAT 2009 A/H1N1 Influenza Test shall be consistent with the Fact Sheets and authorized labeling, as well as the terms set forth in this EUA and other requirements set forth in the Act and FDA regulations.
  6. All advertising and promotional descriptive printed matter relating to the use of the authorized GeneSTAT 2009 A/H1N1 Influenza Test shall clearly and conspicuously state that:
    • This test has not been FDA cleared or approved;
    • This test has been authorized by FDA under an Emergency Use Authorization;
    • This test has been authorized only for the detection of 2009 H1N1 influenza virus and not for any other viruses or pathogens;
  7. This test is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Act, 21 U.S.C. §360bbb-3(b)(1); and
  8. The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner or renewed.
  9. No advertising or promotional descriptive printed matter relating to the use of the authorized GeneSTAT 2009 A/H1N1 Influenza Test may represent or suggest that this test is safe or effective for the diagnosis of 2009 H1N1 influenza virus.
  10. DxNA, LLC will ensure that CLIA High Complexity Laboratories using the authorized GeneSTAT 2009 A/H1N1 Influenza Test have a process in place for reporting test results to healthcare providers and federal, state and/or local public health authorities, as appropriate.
  11. DxNA, LLC will track adverse events and report to FDA as required under 21 CFR part 803.
  12. Through a process of inventory control, DxNA, LLC will maintain records of device usage.
  13. DxNA, LLC will collect information on the performance of the assay and report to FDA any suspected occurrence of false positive or negative results of which DxNA, LLC becomes aware.

CLIA High Complexity Laboratories

  1. CLIA High Complexity Laboratories will include with reports of the results of the GeneSTAT 2009 A/H1N1 Influenza Test the authorized Fact Sheets for Healthcare Providers and the authorized Fact Sheets for Patients.
  2. CLIA High Complexity Laboratories will use the Roche High Pure RNA Isolation Kit for nucleic acid extraction and perform the assay on the GeneSTAT Analytical Platform, ensuring that at least once per day that specimens are to be tested, a known sample (2009 H1N1 positive or influenza A positive specimen) is tested as a positive control for RNA extraction and subsequent protocol steps.
  3. CLIA High Complexity Laboratories will have a process in place for reporting test results to healthcare providers and federal, state and/or local public health authorities, as appropriate.
  4. CLIA High Complexity Laboratories will collect information on the performance of the assay, and report to DxNA, LLC any suspected occurrence of false positive or false negative results of which CLIA High Complexity Laboratories become aware.

DxNA, LLC and CLIA High Complexity Laboratories

  1. DxNA, LLC is authorized to make available additional information relating to the emergency use of the authorized GeneSTAT 2009 A/H1N1 Influenza Test that is consistent with, and does not exceed, the terms of this letter of authorization.
  2. Only DxNA, LLC may request changes to the authorized GeneSTAT 2009 A/H1N1 Influenza Test Fact Sheet for Healthcare Providers or the authorized GeneSTAT 2009 A/H1N1 Influenza Test Fact Sheet for Patients. Such requests will be made by contacting FDA concerning FDA review and approval.
  3. DxNA, LLC will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to FDA for inspection upon request.

The emergency use of the authorized GeneSTAT 2009 A/H1N1 Influenza Test as described in this letter of authorization must comply with the conditions above and all other terms of this authorization.

V. Duration of Authorization

This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.


____________________________

Margaret A. Hamburg, M.D. Commissioner of Food and Drugs

[1] Memorandum, Determination Pursuant to § 564 of the Federal Food, Drug, and Cosmetic Act (April 26, 2009).

[2] No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.