{"id":491,"date":"2021-10-27T13:35:00","date_gmt":"2021-10-27T18:35:00","guid":{"rendered":"https:\/\/herpescureadvocacy.com\/?p=491"},"modified":"2026-05-05T21:24:44","modified_gmt":"2026-05-06T01:24:44","slug":"advocacy-at-the-fda-for-herpes","status":"publish","type":"post","link":"https:\/\/herpescureadvocacy.com\/2021\/10\/27\/advocacy-at-the-fda-for-herpes\/","title":{"rendered":"How to Advocate the FDA for Accurate Herpes Testing"},"content":{"rendered":"\n
\"\"<\/figure>\n\n\n\n

Why do we need advocacy at the FDA? Because any Herpes Simplex Virus prevention strategy in the US is incomplete without an accurate diagnostic test. There is currently NO FDA-approved accurate diagnostic serology test (what we need to diagnose asymptomatic infection) on the market. With a virus that is primarily spread asymptomatically, 85% of new infections are spread by people who are asymptomatic and unaware of their status, the lack of accurate testing is a large and dangerous loophole. People can currently be tested for HSV one of two ways:<\/p>\n\n\n\n

Swab Test: <\/strong>Individuals with symptoms can test skin lesions (oral or genital) with either PCR or culture from an active outbreak.<\/p>\n\n\n\n

Serology (blood) Test: <\/strong>A test of patient blood sample for the presence of HSV antibodies. The presence of antibodies can be measured to indicate the infection in the body. This type of test is meant to be used for routine STI screenings and\/or for asymptomatic patients to diagnose infection. <\/p>\n\n\n\n

The FDA approved serology tests (Herpeselect<\/a> for example) have been proven to have low performance (see studies here<\/a>, here<\/a> and here<\/a>). For this reason, the 2021 CDC STI treatment guidelines<\/a> recommend confirmatory testing with the Western Blot, which is not FDA approved or covered by insurance. <\/p>\n\n\n\n

There are a number of ways Herpes Advocates can ask the FDA to improve the landscape for HSV diagnostics. (Want to join the advocate army? Sign up for emails here<\/a>.)<\/em><\/p>\n\n\n\n

\n\n\n\n

How can I advocate the FDA for better Herpes testing? <\/h1>\n\n\n\n

1. FILE A REPORT. Have a test that was false positive\/negative? <\/strong> <\/h5>\n\n\n\n

Health Care Providers:<\/strong> File a report<\/a> of tests in your clinical practice that are false positive\/negative to the FDA. Providers can do this as often as you are able – each report takes 5 minutes. These reports help the FDA track issues and respond appropriately.<\/p>\n\n\n\n

Patients<\/strong>: Patients can also report their inaccurate tests to the FDA<\/a> – you can order your records from your provider if needed to fill out the form.<\/p>\n\n\n\n

2. Contact the FDA<\/strong> directly:<\/strong> Email the following individuals to say that we need accurate FDA approved serology tests for HSV.<\/h5>\n\n\n\n

PatientAffairs@fda.gov<\/a><\/p>\n\n\n\n

CDRH_PatientEngagement@fda.hhs.gov<\/a><\/p>\n\n\n\n

CBERAdvisoryCommittees@fda.hhs.gov<\/a><\/p>\n\n\n\n

Maria.Garcia@fda.hhs.gov<\/a><\/p>\n\n\n\n

ryan.karsner@fda.hhs.gov<\/a><\/p>\n\n\n\n

Himani.Bisht@fda.hhs.gov<\/a><\/p>\n\n\n\n

kathleen.whitaker@fda.hhs.gov<\/a><\/p>\n\n\n\n

laura.ulitzky@fda.hhs.gov<\/a><\/p>\n\n\n\n

\n\n\n\n
3<\/strong>. File a report of misconduct<\/a> against Focus Diagnostics Herpeselect<\/a>\u00ae 1 and 2 Immunoblot IgG with the FDA.<\/strong><\/h5>\n\n\n\n

Name of the company for which you are submitting an allegation: <\/strong>
Focus Diagnostics<\/p>\n\n\n\n

Telephone number: <\/strong>
800.838.4548<\/p>\n\n\n\n

Address:<\/strong>
DIASORIN MOLECULAR LLC
11331 Valley View Street
Cypress, California, 90630-4717 USA<\/p>\n\n\n\n

Name and model (if applicable) of the Medical Device(s) \/ Electronic Products in question:<\/strong>
Herpeselect\u00ae 1 and 2 Immunoblot IgG<\/p>\n\n\n\n

Lot numbers \/ serial numbers \/ part numbers:<\/strong>
IB0900G<\/p>\n\n\n\n

Under detailed description, please include: <\/strong><\/p>\n\n\n\n

This Herpeselect test has been proven to be inaccurate in a screening population in numerous studies. Additionally, the Product Insert is misleading, as the sensitivity\/specificity study is in a pre-screened population that has already tested positive for HSV with a PCR\/culture test. The studies enclosed show that when the same test is used to SCREEN people whose status is not known, the results are very different and accuracy is suboptimal. <\/em><\/p>\n\n\n\n

In summary, the Product Information is misleading as the intended use for general HSV screening and the study design are not consistent which should be more clearly indicated. <\/em><\/p>\n\n\n\n

See studies proving inaccuracy of this test in population that was not pre-screened here<\/a>, here<\/a> and here<\/a><\/em>. Herpeselect, when used in combination with the confirmatory test Western Blot, does not confirm 50% of the time.<\/em> <\/p>\n\n\n\n

Include the detailed description above in your email.<\/p>\n\n\n\n

\n\n\n\n
\n\n\n\n
\n\n\n\n
Get in touch<\/h5>\n\n\n\n

Want to contact us? You can do so here<\/a>. Or send us an email at info@herpescureadvocacy.com<\/a><\/p>\n\n\n\n

Never miss a thing. Sign up for our newsletter<\/a>!<\/p>\n\n\n\n

Follow us on Twitter<\/a>.<\/p>\n\n\n\n

\n","protected":false},"excerpt":{"rendered":"

Why do we need advocacy at the FDA? Because any Herpes Simplex Virus prevention strategy in the US is incomplete without an accurate diagnostic test. There is currently NO FDA-approvedContinue reading “How to Advocate the FDA for Accurate Herpes Testing”<\/span><\/a><\/p>\n","protected":false},"author":205069572,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_coblocks_attr":"","_coblocks_dimensions":"","_coblocks_responsive_height":"","_coblocks_accordion_ie_support":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"{title}\n\n{excerpt}\n\n{url}","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"_wpas_customize_per_network":false,"jetpack_post_was_ever_published":false},"categories":[5967],"tags":[],"class_list":["post-491","post","type-post","status-publish","format-standard","hentry","category-advocacy","entry"],"yoast_head":"\nHow to Advocate the FDA for Accurate Herpes Testing - Herpes Cure Advocacy<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/herpescureadvocacy.com\/2021\/10\/27\/advocacy-at-the-fda-for-herpes\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How to Advocate the FDA for Accurate Herpes Testing - Herpes Cure Advocacy\" \/>\n<meta property=\"og:description\" content=\"Why do we need advocacy at the FDA? 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Advocacy Alert: Request a Patient Listening Session at the FDA The landscape for prevention of HSV in America is inadequate. There is a critical loophole without an accurate test to diagnose asymptomatic infection. Currently available FDA-approved tests for HSV are inaccurate 50%\u2026","rel":"","context":"Similar post","block_context":{"text":"Similar post","link":""},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/04\/pexels-photo-1181406.jpeg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/04\/pexels-photo-1181406.jpeg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/04\/pexels-photo-1181406.jpeg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/04\/pexels-photo-1181406.jpeg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/04\/pexels-photo-1181406.jpeg?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/04\/pexels-photo-1181406.jpeg?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":1742,"url":"https:\/\/herpescureadvocacy.com\/2021\/12\/28\/key-stakeholders-for-herpes-patient-advocacy\/","url_meta":{"origin":491,"position":1},"title":"Key Stakeholders for Herpes Patient Advocacy","author":"Patient Advocate","date":"December 28, 2021","format":false,"excerpt":"USE YOUR VOICE FOR CHANGE How long until a herpes cure? When asking this question - ask yourself, what can I do to help? Want to know when the next clinical trial for a herpes cure is? Contact your elected representatives - tell them we need more clinical research for\u2026","rel":"","context":"In "Advocacy"","block_context":{"text":"Advocacy","link":"https:\/\/herpescureadvocacy.com\/category\/advocacy\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/03\/bullhorn-web-768x429-1.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/03\/bullhorn-web-768x429-1.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/03\/bullhorn-web-768x429-1.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/03\/bullhorn-web-768x429-1.jpg?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":1891,"url":"https:\/\/herpescureadvocacy.com\/2023\/01\/07\/cdc-issues-request-for-proposal-to-develop-new-serology-test-for-herpes-simplex-virus\/","url_meta":{"origin":491,"position":2},"title":"CDC issues Request for Proposal to develop new serology test for Herpes Simplex Virus","author":"Patient Advocate","date":"January 7, 2023","format":false,"excerpt":"The Centers for Disease Control and Prevention (CDC), the Office of Science (OS) in late December 2022 issued a Broad Agency Announcement (BAA) for the competitive selection of research proposals, including a Request for Proposal (RFP) for a new serologic test for herpes simplex virus (HSV). Therefore, the goal of\u2026","rel":"","context":"With 1 comment","block_context":{"text":"With 1 comment","link":"https:\/\/herpescureadvocacy.com\/2023\/01\/07\/cdc-issues-request-for-proposal-to-develop-new-serology-test-for-herpes-simplex-virus\/#comments"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/01\/pexels-photo-8460349-1024x682.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/01\/pexels-photo-8460349-1024x682.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/01\/pexels-photo-8460349-1024x682.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2023\/01\/pexels-photo-8460349-1024x682.jpg?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":4396,"url":"https:\/\/herpescureadvocacy.com\/2024\/08\/18\/hsv-herpes-testing-diagnosis-treatment\/","url_meta":{"origin":491,"position":3},"title":"Genital Herpes: Diagnosis, Testing, Treatment","author":"Patient Advocate","date":"August 18, 2024","format":false,"excerpt":"Johnston C, Wald A. Genital Herpes. JAMA. 2024;332(10):835\u2013836. doi:10.1001\/jama.2024.12743 Outstanding up-to-date summary of the genital herpes virus, symptoms, testing, and treatment by two of the world\u2019s leading herpes researchers and experts. Published in JAMA (Journal of the American Medical Association), among the most widely read medical journals, Dr. Christine Johnston\u2026","rel":"","context":"In "Herpes Basics"","block_context":{"text":"Herpes Basics","link":"https:\/\/herpescureadvocacy.com\/category\/article\/"},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":1091,"url":"https:\/\/herpescureadvocacy.com\/2022\/04\/05\/fy-2022-budget-includes-national-strategy-and-strategic-plan\/","url_meta":{"origin":491,"position":4},"title":"FY 2022 Budget Includes National Strategy and Strategic Plan for HSV","author":"Patient Advocate","date":"April 5, 2022","format":false,"excerpt":"Herpes Cure Advocacy is pleased to report that with the passing of FY 2022 budget that the Dept. of Health and Human Services National Strategy and Strategic Plan for the treatment and prevention of Herpes Simplex Virus has a budget of $250,000. This small investment in strategic planning is an\u2026","rel":"","context":"With 2 comments","block_context":{"text":"With 2 comments","link":"https:\/\/herpescureadvocacy.com\/2022\/04\/05\/fy-2022-budget-includes-national-strategy-and-strategic-plan\/#comments"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/04\/pexels-photo-129112.jpeg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/04\/pexels-photo-129112.jpeg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/04\/pexels-photo-129112.jpeg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/04\/pexels-photo-129112.jpeg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/04\/pexels-photo-129112.jpeg?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2022\/04\/pexels-photo-129112.jpeg?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":273,"url":"https:\/\/herpescureadvocacy.com\/2021\/07\/18\/the-minimization-of-herpes\/","url_meta":{"origin":491,"position":5},"title":"Reducing Herpes Stigma and\/or Finding a Herpes Cure","author":"Patient Advocate","date":"July 18, 2021","format":false,"excerpt":"Can we advocate for a Herpes cure and reduce its stigma at the same time? It\u2019s a strange dichotomy for many HSV carriers desperate for a cure. Advocacy by its nature needs to elevate the critical elements of an issue which are misunderstood, under appreciated or viewed differently by those\u2026","rel":"","context":"In "Advocacy"","block_context":{"text":"Advocacy","link":"https:\/\/herpescureadvocacy.com\/category\/advocacy\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2021\/04\/vgu1rufkt3wn1zyxswar_14672519443_13d8873062_k.jpg?fit=1200%2C800&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2021\/04\/vgu1rufkt3wn1zyxswar_14672519443_13d8873062_k.jpg?fit=1200%2C800&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2021\/04\/vgu1rufkt3wn1zyxswar_14672519443_13d8873062_k.jpg?fit=1200%2C800&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2021\/04\/vgu1rufkt3wn1zyxswar_14672519443_13d8873062_k.jpg?fit=1200%2C800&ssl=1&resize=700%2C400 2x, https:\/\/i0.wp.com\/herpescureadvocacy.com\/wp-content\/uploads\/2021\/04\/vgu1rufkt3wn1zyxswar_14672519443_13d8873062_k.jpg?fit=1200%2C800&ssl=1&resize=1050%2C600 3x"},"classes":[]}],"_links":{"self":[{"href":"https:\/\/herpescureadvocacy.com\/wp-json\/wp\/v2\/posts\/491","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/herpescureadvocacy.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/herpescureadvocacy.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/herpescureadvocacy.com\/wp-json\/wp\/v2\/users\/205069572"}],"replies":[{"embeddable":true,"href":"https:\/\/herpescureadvocacy.com\/wp-json\/wp\/v2\/comments?post=491"}],"version-history":[{"count":26,"href":"https:\/\/herpescureadvocacy.com\/wp-json\/wp\/v2\/posts\/491\/revisions"}],"predecessor-version":[{"id":7207,"href":"https:\/\/herpescureadvocacy.com\/wp-json\/wp\/v2\/posts\/491\/revisions\/7207"}],"wp:attachment":[{"href":"https:\/\/herpescureadvocacy.com\/wp-json\/wp\/v2\/media?parent=491"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/herpescureadvocacy.com\/wp-json\/wp\/v2\/categories?post=491"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/herpescureadvocacy.com\/wp-json\/wp\/v2\/tags?post=491"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}