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U.S. Department of Health and Human Services

Medical Devices

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Letter of Authorization: ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR Test (Amended February 1, 2010)

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 As of June 23, 2010, the EUAs have been terminated and this information is no longer current.

Dr. Walt Mahoney
VP R&D and Operations
Managing Director
Epoch BioSciences
21720 23rd Drive S.E. Suite 150
Bothell, WA 98021

Dear Dr. Mahoney:

On November 13, 2009 FDA issued a letter authorizing the emergency use of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test for the diagnosis of 2009 H1N1 influenza virus infection, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3) by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. §263a, to perform high complexity tests (CLIA High Complexity Laboratories). On December 22, 2009, Epoch Biosciences submitted a request for an amendment to the Emergency Use Authorization. In response to that request, the letter authorizing emergency use of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test is being reissued in its entirety with the amendments incorporated.1

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.2 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 ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test 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 ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR 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 ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test may be effective for the diagnosis of 2009 H1N1 influenza virus infection, and that the known and potential benefits of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR 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 ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test for the diagnosis of 2009 H1N1 influenza virus infection.3

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 ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection.

The Authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR Test:

The ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test is a real-time reverse-transcription PCR for the in vitro qualitative detection of 2009 H1N1 influenza viral RNA in upper respiratory tract specimens (such as nasopharyngeal swabs (NPS), nasal swabs (NS), throat swabs (TS), nasal aspirates (NA), nasal washes (NW), and dual nasopharyngeal/throat swabs (NPS/TS)), and lower respiratory tract specimens (such as broncheoalveolar lavage (BAL), bronchial aspirate (BA), bronchial wash (BW), endotracheal aspirate (EA), endotracheal wash (EW), tracheal aspirate (TA), and lung tissue) from patients with signs and symptoms of respiratory infection. Amplification and detection are accomplished using PCR primers and Pleiades hybridization probes manufactured by Epoch BioSciences, a Division of Wescor, Inc. The testing procedure consists of nucleic acid extraction on the Qiagen BioRobot 9604 instrument followed by real-time reverse-transcription PCR on the Applied Biosystems 7900HT Real-Time PCR System.

The ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test includes the following primer and probe sets:

  • 2009H1: detects the presence of the hemagglutinin (HA) gene specifically found in the 2009 H1N1 influenza A virus.
  • M1: detects a conserved region of the Matrix Protein 1 (M1) gene that is present in seasonal and 2009-H1N1 influenza A viruses.
  • Bacteriophage MS2 Internal Control: detects RNA sequence in whole bacteriophage MS2 that is noncompetitive with the 2009-H1N1 and M1 targets.

The ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test also includes the following control materials:

  • Bacteriophage MS2 Internal Control (IC) is added to every patient sample and is carried through all steps of the procedure from nucleic acid isolation and purification through amplification to monitor for inhibitors present in the specimen or reaction tube. The IC also serves as a general process control ensuring that each step of the procedure was performed correctly, assay and instrument parameters were set correctly, and that general reagents were working.
  • Negative Control consists of IC diluted with water and is taken through both nucleic acid extraction and PCR processes to demonstrate that no carryover contamination has occurred during the test process (rule out false positives caused by contamination). The Negative Control is incorporated into each batch of patient specimen processing.
  •  Positive Controls consist of separate RNA templates containing targets recognized by the 2009H1 and M1 detection systems. Each Positive Control is taken through both nucleic acid extraction and PCR processes to demonstrate that nucleic acid extraction and PCR are effective (rule out false negatives caused by test failure). The Positive Controls are incorporated into each batch of patient specimen processing.

The ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test requires the following hardware with corresponding software:

  • Applied Biosystems 7900HT Real-Time PCR System with ABI Software: SDS 7900HT, v2.2.2 or v2.3.
  • Qiagen BioRobot 9604 with QIAsoft 3.0 PLUS software.

The ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test requires the use of the following additional reagents/materials:

  • Qiagen QuantiTect Probe RT-PCR Master mix (Qiagen Cat. No 204443)
  • Consumables for Qiagen BioRobot 9604
  • QIAamp Virus BioRobot 9604 Kit (Qiagen Cat. No 965662)
  • RNase Inhibitor (Applied Biosystems Cat. No N8080119)
  • Heat-labile Uracil N-Glycosylase (Roche Cat No 11775367001)
  • MasterAmp 10X PCR Enhancer (Epicentre Cat No ME81210)

The above described ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test, when labeled consistently with the labeling authorized by FDA, entitled ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Package Insert (available at http://www.fda.gov/MedicalDevices/Safety/ EmergencySituations/ucm161496.htm), as may be revised with written permission of FDA, is authorized to be distributed to and used by ARUP Laboratories,4 under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law.

The above described ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR 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: Interpretation of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR Test Results
  • Fact Sheet for Patients: Understanding the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR Test Results

As described in section IV below, Epoch Biosciences, is also authorized to make available additional information relating to the emergency use of the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR 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 ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR 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 ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR 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 ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR 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 ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR 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's determination under section 564(b)(1)(C) described above and the Secretary of HHS's corresponding declaration under section 564(b)(1), the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR 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 ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR 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 ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR 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:

Epoch Biosciences

  1. Epoch Biosciences will distribute the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test with the authorized labeling, as may be revised with written permission of FDA, only to ARUP Laboratories.
  2. Epoch Biosciences will provide to ARUP Laboratories the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheet for Healthcare Providers and the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheet for Patients.
  3. Epoch Biosciences will make available on its website the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheet for Healthcare Providers and the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheet for Patients.
  4. Epoch Biosciences will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.
  5. Epoch Biosciences will ensure ARUP Laboratories has a process in place for reporting test results to health care providers and federal, state, and/or local public health authorities, as appropriate.
  6. Epoch Biosciences will track adverse events and report to FDA as required under 21 CFR part 803.
  7. Through a process of inventory control, Epoch Biosciences will maintain records of device usage.
  8. Epoch Biosciences will collect information on the performance of the assay, and report to FDA any suspected occurrence of false positive or false negative results of which Epoch Biosciences becomes aware.
  9. Epoch Biosciences is authorized to make available additional information relating to the emergency use of the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test that is consistent with, and does not exceed, the terms of this letter of authorization.
  10. Only Epoch Biosciences may request changes to the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheet for Healthcare Providers or the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheet for Patients. Such requests will be made by contacting FDA concerning FDA review and approval.

ARUP Laboratories

  1. ARUP Laboratories will include with reports of the results of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheets for Healthcare Providers and the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheets for Patients.
  2. ARUP Laboratories will clearly and conspicuously state on reports of the results of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test that this test is only authorized for the diagnosis of 2009 H1N1 influenza virus and not for seasonal influenza A, B, respiratory syncytial virus (RSV) or any other pathogen.
  3. ARUP Laboratories will use the Qiagen BioRobot 9604 for nucleic acid extraction and perform the assay on the Applied Biosystems 7900HT Real-time PCR instrument.
  4. ARUP Laboratories will have a process in place for reporting test results to health care providers and federal, state and/or local public health authorities, as appropriate.
  5. ARUP Laboratories will collect information on the performance of the assay, and report to Epoch Biosciences any suspected occurrence of false positive or false negative results of which ARUP Laboratories becomes aware.

Epoch Biosciences and ARUP Laboratories

  1. Epoch Biosciences and ARUP Laboratories will make available on their Web sites the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheets for Healthcare Providers and the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test Fact Sheets for Patients.
  2. Epoch Biosciences and ARUP Laboratories 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.
  3. All advertising and promotional descriptive printed matter relating to the use of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR 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.
  4. All advertising and promotional descriptive printed matter relating to the use of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR 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;
    • 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
    • The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner or renewed.
  5. No advertising or promotional descriptive printed matter relating to the use of the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test may represent or suggest that this test is safe or effective for the diagnosis of 2009 H1N1 influenza virus.

The emergency use of the authorized ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR 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 The amendments to the October 16, 2009 letter authorize use of a) additional upper respiratory tract samples, such as nasal swabs (NS), throat swabs (TS), nasal aspirates (NA), nasal washes (NW), and dual nasopharyngeal / throat swabs (NPS/TS), and lower respiratory tract specimens, such as broncheoalveolar lavage (BAL), bronchial aspirate (BA), bronchial wash (BW), endotracheal aspirate (EA), endotracheal wash (EW), tracheal aspirate (TA), and lung tissue and b) ABI Software SDS 7900HT v2.3 on the Applied Biosystems 7900HT real-Time PCR System. There are also minor wording changes made to be consistent with more recently issued Emergency Use Authorizations for in vitro diagnostic devices.

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

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

4 This EUA does not authorize the ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test to be sold or distributed to or used by other laboratories.