IgM test removal at QUEST Diagnostics is a win for Herpes clinical care

Herpes Cure Advocacy celebrates and thanks Quest Diagnostics for removing the HSV 1/2 IgM test from their product offerings. Quest Diagnostic joins Mayo Clinic in the removal of this test from their product offerings. This is a win for herpes advocacy and a small step forward to better clinical care for Herpes Simplex Virus in the US.

On March 17th 2022 QUEST leadership confirmed:

“Thank you for reaching out regarding Quest Diagnostics offering of Herpes Simplex Virus (HSV) 1/2 IgM antibody testing. We are in the process of discontinuing this test code as a standalone test as well as HSV 1/2 IgM that is within some testing panels.”

The IgM test is a serology test for HSV 1/2 antibodies indicated to diagnose very recent infection within 7-10 days. This test has historically proven to be highly inaccurate, with false positive/negative results nearly 50% of the time. Resulting in many patients being told they are HSV positive or negative erroneously. The CDC has been recommending against this for decades doctors have been using this test. Per 2021 CDC STI Treatment Guidelines:

Immunoglobulin M (IgM) testing for HSV-1 or HSV-2 is not useful because IgM tests are not type specific and might be positive during recurrent genital or oral episodes of herpes (460). Therefore, HSV IgM testing is not recommended.

Please see the test to be removed here.

Accurate diagnostic tools are the foundation of prevention strategy to reduce prevalence and understand spread of any infectious disease. Learn more about why more accurate diagnostic tests for HSV are critically needed.




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Herpes Cure Pipeline 2.0

Pipeline for a Herpes Cure

We track the timelines for preclinical and clinical study, formulation updates, and go-to market strategies with research teams globally.

The pipeline only includes teams with published data, and those with expressed interest of bringing a product to market. There is no other organization globally except Herpes Cure Advocacy, who are advocating, tracking, or keeping HSV advocates informed on the pipeline for a Herpes treatment or cure.

The original 1.0 edition of our pipeline was published on November 25, 2021 and continues to provide a critical service for advocates, industry, and research teams globally. Hundreds of visitors globally view the pipeline daily and it continues to be the most visited page on www.herpescureadvocacy.com.

Herpes Cure Pipeline 2.0

Pipeline projects include HSV cure or treatment research teams who have expressed intent of bringing a product to market.

Have a project to add? Email our team.



Changes of note:

  • The tracker has been divided into sections to group research items by vaccine or treatment types
  • Timing update to Harvey Friedman UPenn/BioNTech clinical trials to begin September 2022
  • Timing update and reformulation for Xvax Vaccines to begin clinical trials 2024
  • Shanghai Bdgene has been updated to reflect early success of Phase I/II trials in China (pending formal report) and that they are now seeking IND approval to begin trials in the U.S.
  • SL Vaxigen’s “SL-V20” HSV-2 therapeutic vaccine has been added and reflects completion of recruiting for Phase I trial in Korea
  • Blue Willow is now targeting 2022 or 2023 to start human clinical trials for their “NE HSV-2” therapeutic and prophylactic vaccine candidate
  • Thyreos “R2” HSV 1&2 vaccine candidate has been added, but there are little details on timing of clinical trials
  • AiCuris’ Pritelivir has been updated to indicate they are currently recruiting for Phase III clinical trials in the U.S. (they may be recruiting worldwide – we are trying to confirm)
  • Heidelberg completed Phase II trial on their “HDIT 101” HSV 2 monoclonal antibody treatment
  • BioPharma‘s “UB-621” now reflects three different candidates for their HSV-2 monoclonal antibody treatment
  • Nanoviricide’s HerpeCide Program, which is antiviral treatment, now reflects multiple programs in process for HSV 1 & 2 and including HSV-1 keratitis   


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Advocacy Preparations for FY 2023

The Herpes Cure Advocacy team is getting ready for another busy appropriations season and we need your help. Appropriations is the government process of creating a budget and deciding how public funds are spent. Every year – advocates of all kinds hold “appropriations request” meetings to ask for funds. We have a goal of meeting with elected representatives in all 50 states this year.

Can you help us reach elected in reps where you live?


Use your voice

Contacting your elected representative

We are creating a database (our HSV Advocate Army) for coordinated advocacy meetings with patient and provider advocates in all 50 states. Please let us know what state you live in by clicking here.

Contact your elected representatives: Here’s what to say:

  1. Please increase public funds in the FY 2023 budget for Herpes cure, treatment and prevention.
  2. Please ask to schedule a meeting (virtual is fine) with your reps health policy staff. HCA team members can join you for a live meeting with your elected representatives to help speak to the issues.
  3. Please ALWAYS copy info@herpescureadvocacy.com so we’re aware of when advocacy emails are sent. It also adds legitimacy to your request and helps us not duplicate HCA advocacy efforts with other advocates in your jurisdiction.
  4. Always introduce yourself as an advocate with Herpes Cure Advocacy. A sample letter/email is here. A few tips:
  • Be polite – but firm! Say thank you!
  • Email.
  • Call.
  • Ask for a virtual or in person meeting to discuss further.
  • Do all of the above!

If your elected rep is on any of the committees below – please let us know ASAP! We most critically need to reach these committee members and can be more effective with the help of their constituents.

United States SenateUnited States House of Representatives
Senate Appropriations Committee
Senate LHHS Subcommittee
Senate HELP Committee
House Appropriations Committee
House LHHS Subcommittee



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Moderna Adds Herpes Vaccine Candidate to Pipeline

Moderna is entering the global race for a Herpes vaccine. Moderna is an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts that focuses on RNA therapeutics, primarily mRNA vaccines.  They are best known for recent success with their mRNA-based COVID-19 vaccine.

From Moderna website: Moderna’s herpes simplex virus (HSV) vaccine candidate (mRNA-1608) is a vaccine candidate against HSV-2 disease. Moderna expects that an HSV-2 vaccine could provide cross-protection against HSV-1. With mRNA-1608, the Company aims to induce strong antibody response with neutralizing and effector functionality combined with cell-mediated immunity. There is no vaccine approved against HSV.

More details on the Moderna website here.


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Harvey Friedman provides hope for an HSV Vaccine at the University of Pennsylvania

Researchers, led by Dr. Harvey Friedman, from the Perelman School of Medicine at the University of Pennsylvania are close to clinical trials testing a vaccine protecting against genital herpes. Phase I trials for this HSV vaccine candidate, that will test prevention of genital herpes in humans, are expected to begin in September 2022.

In 2019, UPenn first published news that a novel mRNA-based genital herpes vaccine had been developed that protected almost all animal subjects exposed to the virus in preclinical studies in Dr. Harvey Friedman’s lab.

This work is in partnership with BioNtech and Dr. Drew Weissman, creators of Pfizers Covid vaccine. Latest studies in mice by Dr Friedman have shown his vaccine candidate is effective at preventing genital infection caused by HSV-1. Additional studies from July 2020 and in October 2021 have also shown the same efficacy for HSV-2.

Dr. Friedman’s lab has indicated they are also doing preclinical testing on a therapeutic. Depending on results from the prophylactic vaccine, work on a therapeutic treatment to HSV-1 or HSV-2 may not be far behind. See recent video updates from Dr. Friedman provided from February 2021, and November 2021. Learn more on Dr. Friedman’s lab website here.

Want to help? Donate today to help advance Dr. Friedman’s work for the study of a therapeutic HSV treatment! Fundraising is underway, led by a Reddit group dedicated to dialogue on Herpes Cure Research.


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“Moving Beyond a 45 year old antiviral” Article in BioCentury Magazine

Herpes Cure Advocacy win! Our team worked with editors at Biocentury magazine on this article. Enjoy!

After a decades long lull in innovation, a wave of candidates is advancing through the HSV pipeline that could combat drug resistance, suppress viral deactivation, or even clear the virus completely.”

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Hope for Herpes Keratitis Cure in China: Study results expected in 2022

In the global race for a Herpes cure, China is taking the lead. For the first time, transient gene-editing of the herpes simplex virus type 1 (HSV-1) using mRNA-based CRISPR was shown to cure herpes keratitis in mice. Chinese researchers reported in a paper published January 11, 2021 of Nature Biotechnology.

In a paper published May 2021, the team from Shanghai showed therapeutic efficacy in three different Herpes Simplex Keratitis (HSK) mouse models and human-derived corneas. The approach, an HSV-1-erasing lentiviral particle (referred to as HELP), was shown in these pre-clinical studies to significantly block HSV-1 replication and HSK occurrence in three different infection models, and eliminated the viral reservoir in the ganglia.

Shanghai BD Gene is now currently in a phase 1/2 clinical study studying the HELP approach in humans with final study results expected May 2022. This study, CRISPR/Cas9 mRNA Instantaneous Gene Editing Therapy Assisted Corneal Transplantation in the Treatment of Refractory Viral Keratitis, may facilitate the development of therapeutics targeting other viruses, including HSV-2, (HPV) and Hepatitis B (HBV). This is the first clinical study of CRISPR in the antiviral field and is Chinas first completely self-developed original gene therapy vector.

Patients worldwide are highly anticipating “first time in humans” clinical study results. Early results show that study subjects are effectively cured of the virus within 4-10 months and company representatives are expecting final results to show HELP is the worlds first proven treatment to cure for Herpes Keratitis. HELP is giving much hope to HSV carriers worldwide.

Dr. Cai Yujia, the corresponding author of the study, said: “Realizing the instantaneous delivery of gene editing enzymes in the body is the dream of our gene therapy scientists. With such a vector, we can maximize the safety of gene editing therapy, which also means The in vivo treatment of gene editing is infinitely close to clinical application.”

In August 2021, Shanghai BD Gene signed R&D cooperation agreements to explore the application of BDGene core delivery technology PVP-mrna in other major diseases such as nervous system diseases. They have also added HSV-2 to their pipeline although company reps indicate the approach is different than HSK. HSK is easier to administer treatment via intrastromal injection to the eye. For HSV-2, administering the treatment is more challenging, but something Shanghai BD Gene is considering. Alternatively this team is considering a viral-like approach for HSV-2 using mRNA.

Patient Advocates are hopeful that China, without the lengthy red tape and regulatory processes of the FDA that can take decades, bringing this treatment to market can happen quickly. Estimates indicate once results are published and peer reviewed in May 2022 that this treatment could be in the clinic, and available on the market for patients treatment, within 5 years.

Stay in touch



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Key Stakeholders for Herpes Patient Advocacy

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 HSV.

Contact your elected representatives to ask them to prioritize Herpes cure, treatment and prevention. Especially important stakeholders in congress are on the committees below.

A sample letter/email is here.

US SenateUS House of Representatives
Senate Appropriations Committee
Senate LHHS Subcommittee
Senate HELP Committee
House Appropriations Committee
House LHHS Subcommittee

United States Preventative Services Task Force (USPTSF)

Why advocacy at USPSF? USPSTF establishes guidelines for medical screening in the United States. They currently recommend against screening for HSV. Learn more about them here.

Dr. Karina W. Davidson USPSTF Committee Chairchair@uspstf.net
kdavidson2@northwell.edu
General Info info@uspstf.net
Dr. Amanda Borsky
Dissemination and Implementation Advisor
Agency for Healthcare and Research Quality
Amanda.borsky@ahrq.hhs.gov

CDC: Department for Prevention of Sexually Transmitted Diseases

Why advocacy at CDC? Herpes spreads in America without public health intervention. The Center for Disease Control and prevention is responsible for prevention, surveillance, and establishes guidelines for testing and treatment for HSV in the United States. They currently recommend against screening for HSV. New STI treatment guidelines for HSV were published in 2021. Learn more about the CDC and their work here.

  • Increase prevention efforts, outline a clear strategy to reduce transmission for HSV in the United States
  • Increase training for new STI Treatment guidelines so that more people get tested (mild symptoms qualify someone for testing!)
  • There is a critical public health need for a functional, accurate, diagnostic test to diagnose asymptomatic infection
Dr. Jono Mermin
Director of the National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)
jhm7@cdc.gov
Dr.  Leandro Mena, MD, MPH                                              
Director, Division of STD Prevention (DSTDP)
boe2@cdc.gov
Dr. Demetre Daskalakisyzq5@cdc.gov
Raul Romaguera
Acting Deputy Director (DSTDP)
rar2@cdc.gov
Dr. Laura Bachmann
Chief Medical Officer, DSTDP
frg6@cdc.gov
Jennifer Ludovic
Lead Public Health Policy Analyst , CDC
bmp8@cdc.gov
STI Treatment Guidelines Commentsstdtxguidelines@cdc.gov

FDA Contacts and Committees

Why advocacy at FDA? The FDA reviews and approves new foods and medical products and provides regulatory oversight for businesses with products on market. The currently FDA-approved serologic antibody tests for diagnosing asymptomatic infection are wrong 50% of the time. Tell the FDA that we need higher standards for diagnostic tests! More background on the need for advocacy at the FDA is here.

More steps you can take on advocacy at the FDA!

Patient Affairs Mailbox Patientaffairs@fda.hhs.gov
Center for Biologics Evaluation and Research (CBER) CommitteeCBERAdvisoryCommittees@fda.hhs.gov
Dr. Himani Bisht
Assistant Director, Division of Microbiology and Devices
Himani.Bisht@fda.hhs.gov

NIH: National Institute for Health: NIAID

Why advocacy at NIH? National Institutes of Health is responsible for research and development to bring new medical innovations to market in the United States. They fund both intra-curricular and extracurricular research through a robust grant program.

Dr. Emily Erbelding
Director of the NIAID Division of Microbiology and Infectious Diseases (DMID)
emily.erbelding@nih.gov
Dr. Barbara Mulach
Director, Office of Scientific Coordination and Program Operations, DMID
bmulach@niaid.nih.gov
Dr. Carolyn Deal
STIs Section Chief
cdeal@niaid.nih.gov
Thomas Hiltke
STIs Section Chief, STI Vaccines and Therapeutics Program Officer
thiltke@niaid.nih.gov
Dr. Jeffrey Cohen
Chief, Laboratory of Infectious Diseases
Chief, Medical Virology Section
jcohen@niaid.nih.gov

Other interest groups
Lynn Barclay
ASHA, Chief Executive Officer
lynnbarclay@ashasexualhealth.org
Fred Wyand
ASHA, Communications
FreWya@ashasexualhealth.org
Asa Radix
ASHA, Board President
aer2130@columbia.cumc.edu
Adolescents 2030info@adolescents2030.org
Beaumont Foundationcastrucci@debeaumont.org
Black Maternal Health Caucus (US Congress)BlackMaternalHealthCaucus@mail.house.gov

Get in touch


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Herpes Cure Pipeline

Where are we with a Herpes Cure? Our team is tracking HSV research worldwide. (Updated 11/24/21)

These are research projects for Herpes Simplex Virus cure, vaccine, or treatment improvements globally with expressed intent of bringing a product to market.

View the Herpes research pipeline here.

Have a project to add to this list? Contact us at info@herpescureadvocacy.com.




WE NEED YOUR HELP! Learn more about our fundraising goals and donate today.

Have a news tip? Are you working on clinical research for HSV treatments and want to share updates with the public? Let us know!

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