"​INFECTIOUS DISEASE Feb. 16 2018
First Multiplex Test for Tick-Borne Diseases
PROMISING TO REVOLUTIONIZE DIAGNOSIS, A SINGLE BLOOD TEST CAN NOW ACCURATELY DETECT IF SOMEONE HAS LYME DISEASE AND/OR ONE OF SEVEN OTHER TICK-BORNE DISEASES
A new blood test called the Tick-Borne Disease Serochip (TBD Serochip) promises to revolutionize the diagnosis of tick-borne disease by offering a single test to identify and distinguish between Borrelia burgdorferi, the pathogen responsible for Lyme disease, and seven other tick-borne pathogens. Led by scientists at the Center for Infection and Immunity (CII) at Columbia University’s Mailman School of Public Health, the research team reports details on the new test in the journal Nature Scientific Reports.

The researchers—who also include scientists from the Centers for Disease Control and Prevention, National Institute of Allergy and Infectious Diseases, Roche Sequencing Solutions, Farmingdale State College, and Stony Brook University—sought to improve on existing tests for tick-borne diseases (TBDs), which have limited diagnostic accuracy and cannot test for more than one infection simultaneously. Currently, diagnosis of Lyme disease, the most common TBD, requires two separate tests. This cumbersome approach also relies on subjective criteria for the interpretation of results, and accurately identifies fewer than 40 percent of patients with early disease and results in false positives 28 percent of the time. The accuracy of the method used to diagnose TBDs Babesia, Anaplasma, Ehrlichia, and Rickettsia varies widely among testing laboratories. And for other tick-borne agents, specific blood tests are not yet available, or in the case of the potentially deadly Powassan virus or Heartland virus, are only performed in specialized laboratories.

“The number of Americans diagnosed with tick-borne disease is steadily increasing as tick populations have expanded geographically,” says Rafal Tokarz, PhD. “Each year, approximately 3 million clinical specimens are tested for TBDs in the U.S. Nonetheless, the true incidence of TBDs is likely greatly underestimated, as patients with presumed TBDs are rarely tested for the full range of tick-borne agents, and only a fraction of positive cases are properly reported,” adds Nischay Mishra, PhD. Co-lead authors Tokarz and Mishra are associate research scientists in the Center for Infection and Immunity.

The TBD Serochip can simultaneously test for the presence of antibodies in blood to more than 170,000 individual protein fragments. Version 1.0 can identify exposure to eight tick-borne pathogens present in the U.S., including Anaplasma phagocytophilum (agent of human granulocytic anaplasmosis), Babesia microti (babesiosis), Borrelia burgdorferi (Lyme disease), Borrelia miyamotoi, Ehrlichia chaffeensis (human monocytic ehrlichiosis), Rickettsia rickettsii (Rocky Mountain spotted fever), Heartland virus and Powassan virus. The researchers also included Long Island tick rhabdovirus, a novel virus they recently discovered in Amblyomma americanum ticks. As new tick-borne infectious agents are discovered, the TBD-Serochip will be modified to target them—a process the researchers say can be done in less than four weeks.

The TBD Serochip is also able to identify whether an individual is infected with more than one tick-borne pathogen. Individual ticks are frequently infected with more than one agent; Ixodes scapularis ticks alone can transmit at least five human pathogens. Evidence of exposure to other tick-borne pathogens in patients with Lyme disease has been well documented. In the new paper, the researchers report finding antibodies to another agent in 26 percent of blood specimens from patients with TBD.

In addition to its utility as a diagnostic platform, the TBD Serochip also provides a powerful research tool for studies of TBDs. The technology can be employed to discriminate individual antibody responses in patients with TBD and thus examine the interplay of TBD agents on disease manifestation and progression. It can also be used to assess the impact of genetic diversity of tick-borne pathogens on the host immune response.

“Diagnosing tick-borne illness is a difficult journey for patients, delaying effecting treatment,” says senior author W. Ian Lipkin, MD, director of CII and John Snow Professor of Epidemiology at Columbia University’s Mailman School of Public Health. “The TBD Serochip promises to make diagnosis far easier, offering a single, accurate test for eight different TBDs. Early detection of infection enables rapid and appropriate treatment.”

Co-authors include Thomas Briese, Teresa Tagliafierro, Stephen Sameroff, Adrian Caciula, Lokendrasingh Chauhan, of CII; Jigar Patel and Eric Sullivan of Roche Sequencing Solutions, Madison, WI; Azad Gucwa of Farmingdale State College, Farmingdale, NY; Brian Fallon of Columbia University; Marc Golightly of Stony Brook University; Claudia Molins and Martin Schriefer of Centers for Disease Control and Prevention; and Adriana Marques of National Institute of Allergy and Infectious Diseases.

This study was funded through grants from the Steven & Alexandra Cohen Foundation and the National Institutes of Allergy and Infectious Diseases (AI109761). The content of study does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. government. CII has filed an invention report and provisional patent application for the technology.  "
www.mailman.columbia.edu/public-health-now/news/first-multiplex-test-tick-borne-diseases

Update on Subcommittee Membership (posted March 2, 2018) The Department of Health and Human Services announces changes to the composition of three of the six subcommittees of the Tick-Borne Disease Working Group (Working Group). The changes were made in response to three members who did not accept the invitations they received to be a part of a subcommittee. New members were selected from the list of existing nominees by the Co-Chairs of the affected subcommittees. The Chair and Vice-Chair of the Working Group provided input and approved the final changes. Robert Bransfield, MD, a private practice physician and Associate Clinical Professor in the Department of Psychiatry at Rutgers-RWJ Medical School, has replaced Susan Green, JD, on the Access to Care and Support to Patients subcommittee. After careful consideration, Ms. Green withdrew her name. David Roth, JD, has accepted a Co-Chair position on the Testing and Diagnostics Subcommittee, of which he is an existing member. Vanilla Singh, MD, was not able to accept the invitation to serve as Co-Chair because of additional duties she has been asked to perform in the Office of the Assistant Secretary for Health. Dr. Singh remains a federal member of the Tick-Borne Disease Working Group.  Holly Ahern, MS, Associate Professor of Microbiology at SUNY Adirondack, has accepted a position on the Testing and Diagnostics Subcommittee. David Walker, MD, who was selected for the Vaccine and Therapeutics subcommittee, withdrew his name for personal reasons.  The subcommittee will proceed with the existing members.
53 Members Named to Serve on Working Group Subcommittees (posted February 6, 2018) The Department of Health and Human Services (HHS) announces the names of 53 individuals who have been selected to serve on one of six subcommittees of the Tick-Borne Disease Working Group (Working Group).  After reviewing the nominations, selections were made by the co-chairs overseeing each of the subcommittees. The Chair and Vice-Chair of the Working Group provided input and approved the final selections. All of the individuals were notified today, but they have not yet confirmed their availability to serve on the subcommittee that they were chosen to join. The final list of subcommittee members will be updated if any of them are no longer able to join a subcommittee. These subcommittees were established by the Working Group members during the December 12, 2017 meeting to assist them in identifying and reviewing information that provides the background, context, and evidence needed to develop the report to Congress and the HHS Secretary as required by the 21st Century Cures Act. The subcommittees will be led by members of the Working Group. The Chair and Vice-Chair of the Working Group will work in collaboration with the subcommittee Co-Chairs and the Designated Federal Officer to ensure that the work of the subcommittees is consistent with the needs of the Working Group and committee management laws and regulations. The roles of the subcommittees, the work they will be doing, and the reports that they will provide to the Working Group will discussed at the February 12, 2018 meeting.

​​FDA approves first tests to screen for tickborne parasite in whole blood and plasma to protect the U.S. blood supply

March 6, 2018 Release
The U.S. Food and Drug Administration today approved the Imugen Babesia microtiArrayed Fluorescent Immunoassay (AFIA), for the detection of antibodies to Babesia microti (B. microti) in human plasma samples, and the Imugen Babesia microtiNucleic Acid Test (NAT), for the detection of B. microti DNA in human whole blood samples. These tests are intended to be used as donor screening tests on samples from individual human donors, including volunteer donors of whole blood and blood components, as well as living organ and tissue donors. “The U.S. blood supply remains the safest in the world thanks in part to the FDA’s ongoing work to enforce standards for blood collection and to identify and respond to potential threats to the nation’s blood supply. While babesiosis is both preventable and treatable, until today, there was no way to screen for infections amongst blood donors,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Today’s actions represent the first approvals of Babesiadetection tests for use in screening donors of whole blood and blood components, and other living donors.” Babesiosis is caused by Babesia parasites that are transmitted by Ixodes scapularisticks, also known as blacklegged or deer ticks. B. microti is the main species that causes infection in the U.S. There are about 1,000 to 2,000 cases of babesiosis reported in the U.S. each year, with the majority reported from states in the Northeast and upper Midwest. Babesia can also be transmitted by transfusion of blood or blood components collected from an infected donor. The vast majority of people infected with B. microti do not have symptoms and are never diagnosed. Some people develop flu-like symptoms, such as fever, headache and body aches. The U.S. Centers for Disease Control and Prevention (CDC) warns that for certain people, especially those with a weak immune system, it can be a severe, life-threatening disease and that while bloodborne transmission of babesiosis is thought to be uncommon, it is the most frequently reported transfusion-transmitted parasitic infection in the U.S. and remains an important concern. The investigational use of Babesia donor testing has been in place since August 2012 in selected Babesia endemic areas under investigational new drug applications (INDs). The use of the investigational tests has resulted in the removal of a significant number of infected units from the blood supply. The data collected from this testing and from additional studies performed by the manufacturer prevented the release of hundreds of potentially infectious donations and demonstrated that the tests are effective in screening donors for B. microti infection. The tests approved today are not intended for use in the diagnosis of babesiosis infections. These applications were granted Priority Review, under which the FDA’s goal is to take action on an application within six months where the agency determines that the product, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition. There currently is no FDA guidance for the testing of donor samples for Babesia. However, the FDA is planning to issue draft guidance with recommendations for reducing the risk of transfusion-transmitted babesiosis later this year. The approval of the Imugen Babesia microti AFIA and NAT tests was granted to Oxford Immunotec, Inc. Both assays are in-house tests that can only be performed at the Norwood, Massachusetts facility. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. ### Inquiries
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I had the opportunity to speak with PA State Rep. Jonathan Fritz this evening in a round table call in session. I would like to thank him for taking the time to do these events and for taking my questions and comments.

My questions was what is being done to get a more standardized treatment to first bites? I followed with three quick stories on the last couple of days, being that I've talked to a couple of people in the last few days, one having removed 14 ticks from her at one time, and another having facial palsy but being told he has Lyme but it's not active. "If it's not active, then why now with the palsy, and if it's not Lyme that's active is it a co-infection that he wasn't tested for, and why not?" I told him I realized he wasn't a doctor, but there have been PADOH bulletins issued, and they are being ignored "How can we get the doctors to utilize the National Clearing House guidelines that have been updated on line?" I also told him even my son received 2 pills when the new guidelines are 28 day course and have been shown in studies to help prevent chronic cases of disease.

Rep. Fritz followed by telling me that the State and two counties Wayne and Susquehanna have developed task forces and have been out to spread awareness, and that's what we need to be doing. Get out and spread awareness to get people talking, and that he knows Susquehanna Counties Task force has done just that.

I informed him that I was on that task force, that we'd formed our Coalition and that I personally dropped of information at his office a while back. That our Lyme Disease Coalition, Inc. has developed a PowerPoint presentation for elementary age children currently waiting to hear from the superintendent of Montrose Area School District to get it started and it also comes with a follow along booklet with activities for the kids to make it fun for them to learn about ticks and be more aware. We also have tick kits we've been handing out at our events to get people practicing prevention.

He had told me that we needed to tell our doctors what we want as far as being tested because we are their customers.

I let him know that I asked for co-infection testing over 3 years ago, and had been denied until just this past week when I about demanded it. I let him know that I never had issues with my back or joints and things and I had to tell the doctors I thought it could be other then lyme such as MS in order to get the mri's I fnally received and confirmed what I'd thought. (Damage)

Rep. Fritz also indicated that we needed to talk to our Doctor friends... and I let him know that even the doctors that want to help us still can't because they are controlled by the facilities they work for and we need standardization within these facilities to get them treating by the new guidelines put out by the National clearing house. I followed by letting him know our doctors are telling us they won't order the tests because our insurance won't cover it and THAT IS something he can help with. Get legislation that mandates the insurance co's cover what is posted as guidelines on that NCH web site.

He said he would post on his website, and see what kind of reaction they get.

What I didn't tell him is the reason we got moving on the Coalition, was lack of funding for those awareness events the county task force was doing. That only a couple of us were funding much of it out of our own pockets... That 3 parents in one day told me their children were sick, two having heart issues caused by Lyme carditis, and another with severe gi and neuro. issues, and that's why we started the non-profit recognized 501c3 Lyme Disease Coalition, Inc.
We felt we needed to do more than what was being done, and couldn't afford to do it alone. We needed to get the community involved because we saw an epidemic on the rise and wanted to start protecting as many as we could with the support of our community because our government was doing very little and very slow.

We can't do much about getting doctors and insurance co's to change until we do get government behind us, but we can help to curtail the new infections with preventative measures.

I also didn't get to talk to him about our tick drags for surveillance.
The one whom I spoke to that took the 14 ticks off her, had no insurance.... and of those 14 ticks I can only estimate 30-50% infection rate per other surveillance studies conducted by nearby schools as we have NO studies being done locally to know what the real risk is. So when 14 ticks are on one person and the guess on exposure is even low at 30%... what do you suppose is the chance she contracts Lyme and a co-infection, with absolutely no insurance and treatment? (30% of those 14 ticks!)

Gene Yaw blew me off when I wrote to him, telling me that I should be writing to another Senator who is dealing with the Lyme issue. (not his exact words)

So again, I'd like to thank #PAStateRepJonathanFritz again for taking my call and time to listen to what some of our issues are.
If more of you would contact our government officials and let them know your stories and lack of treatment, maybe they will start to listen.

Also please send a photo of you to our facebook page, and ask us to add you to our "faces of LYME" with a brief story of yours for the caption. We need to get faces to this disease so they can see just how many of us there are. Please also consider sending photos of your children and pets that have Lyme and related diseases... I'll get a new album for the pets very soon.

Thank you for taking the time to write to your representative and helping to get us heard!