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3/23/2018 Comments

Columbia University Quoted Article

"​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
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3/23/2018 Comments

Stop the Silence!


Lyme disease, Opioid addiction, Suicide~ What to the three have to do with one another?
Hopelessness…

Let’s take a look at three major increasing risks here in Pennsylvania. While all are on the rise, opioid addiction and suicide are being taken seriously. Many in both the medical community and the local government are all backing funding for anything to support a decrease, yet Lyme disease is still pushed off to other areas.

How do you combat these critical issues? Just one thought since anyone with a chronic illness suffers with decisions on all of the above…
Suicide often thought of while living with increasing pain and the inability to get relief, feelings of being alone with no “support team”.  Does this Sound familiar? It does to anyone living with a chronic illness, especially if that illness is not well known or understood.
Let’s also look at why and how people get addicted to opioids….
Does it start out with a prescription for pain? The kind of pain that doesn’t seem to go away?  The kind caused by an incurable disease the medical community would like to ignore?

People need the ability to function.  When you live with pain on a non-stop basis, your muscles spasm, nerves get damaged in ways that leave a permanent pain in many cases. Some may come from an injury; others come from viruses or bacteria such as Lyme disease that invade your body.  MS, lupus type illnesses caused by unknown sources. Although Lyme disease is getting more recognition and showing possibly to be linked to many of these other conditions, it leaves many untreated, undertreated and left on their own defenses. The reasons appear to be a disagreement in the medical community in treatment. Otherwise call "Lyme Wars". Many scientists for years have searched for and studied antibiotics that will cure this disease with no one certain treatment being successful. Others do not believe extended courses of an antibiotic will help withholding further treatment for the bacteria, while issuing either painkillers or some kind of psychiatric drug to alter how the brain deals with pain. That brings us to the opioid addiction.

Many of our citizens’ once active healthy contributing members of society cecum to a life of isolation caused by the pain they suffer. While many can’t see how they suffer due to pain that can’t be seen, they then ridicule the patient due to their lack of work and contribution to society of which they once were very active with. The majority of those now suffering in pain were for many years, not only performing a normal job, but several side jobs, or volunteers at events including sporting events for their children.  Their work ethics and history overlooked once they fell sick with either pain or inability to think. Scorned by the very people who were supposed to “love” them.  This is isolation and another kind of pain. Painkillers or brain altering kind of drugs the medical community will prescribe become the only relief insurance will cover.

Therapies such as physical therapy, chiropractic care, acupuncture and even natural herbal remedies all shown in studies to help elevate or illuminate pain along with talk therapy (counseling) are not covered enough by insurances.  One patient can be taking a pharmaceutical that costs over $200, multiply that by the several being taken by just one patient $600 let’s say, just for a light figure. This cost for one month would more than cover a months’ worth of either of the other “therapies” mentioned previously but are billed as a co-payment of at least $40 each visit. This type of treatment also calls for a “referral” (script) from their PCP.  If this type of therapy, any combination of therapies, were to be covered to the extent the pharmaceuticals are, common since shows not only a decrees in the financial obligations, a decrees for the need in pain meds, improving the quality of life.  
Improve the quality of life and reduce the risk of addiction and suicide.

When scientific studies show effectiveness of alternative therapies for pain and our insurance companies won’t pay at the same rate as a pharmaceutical drug there is something wrong with our system and changes need to be made.  This inability to cover the larger co-payment drives patients to the less expensive alternative.

This is a start to reducing all three of these critical conditions.  It does not cover all the problems with any of the three but it does address part of all three of these issues and is not something we can do alone, “we the people” need the help of those who pass legislation to insure proper care to our citizens.  Fair treatment means the therapies that have shown to be effective in studies to reduce pain, also reducing the effects of chronic conditions all get fair and equal insurance coverage to make it affordable to those who might otherwise turn to the “drugs” or “suicidal” relief.
Join in the fight against all of these diseases to help reduce the future increase in fatal outcomes.
Write your representatives and make a small donation be it in-kind or monetary, every small contribution adds up and shows those suffering they are not “isolated” or alone.
Lyme Disease Coalition, Inc. – 570-500-LYME (5963)
​ldc@lymediseasecoalition.org





 “STOP THE SILENCE”!
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3/8/2018 Comments

Tick-Borne Diseases Federal Working Group Update

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.

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3/8/2018 Comments

FDA NEWS RELEASE!

​​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
Media   Megan McSeveney
  240-402-4514
Consumers   888-INFO-FDA Related Information FDA: Infectious Disease Tests CDC: Babesiosis Follow FDA Follow @US_FDAon Twitter  Follow FDAon Facebook  Follow @FDAmediaon Twitter  Page Last Updated: 03/06/2018 
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599782.htm?utm_campaign=03062018_PR_tick%20born%20illnesses&utm_medium=email&utm_source=Eloqua

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    Author

    Colleen Schake
    Patient-​Living with Lyme
    Lyme Disease Coalition, Inc. - Founder
    Lyme Scout - Founder

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