Archive for the ‘Activism’ Category

NY Grants Approval for IGeneX’s Newly Developed Tick-Borne Relapsing Fever ImmunoBlot Tests

New York State Grants Approval for IGeneX’s Newly Developed Tick-Borne Relapsing Fever (TBRF) ImmunoBlot Tests

TBRF ImmunoBlots (IgM and IgG) represent a quantum leap in testing for tick-borne diseases, particularly for patients with Lyme-like symptoms



MILPITAS, Calif., Oct. 8, 2019 /PRNewswire/ — The Division of Laboratories of the Department of Health of the State of New York has approved IGeneX’s newly developed Tick-Borne Relapsing Fever (TBRF) ImmunoBlots (IgM and IgG), making them immediately available to New Yorkpractitioners.

Until recently, diagnostic tests for TBRF have been grossly insensitive and have not been able to detect many of the ever-growing list of species and strains of TBRF Borrelia carried by hard and soft ticks. The new IGeneX ImmunoBlots overcome these obstacles with the ability to detect antibodies to TBRF Borrelia species including, but not limited to, B. hermsii, B. miyamotoi, and B. turicatae.

TBRF is often considered a Lyme disease imitator because both TBRF and Lyme sufferers display many similar symptoms, such as high fever, chills, and headache, often leading to misdiagnosis. Moreover, some of the Borrelia that cause TBRF are transmitted by the same ticks that transmit B. burgdorferi, the causative agent of Lyme disease. Therefore, it is important for physicians to test for both TBRF and Lyme.

“We are very excited to be able to offer the TBRF ImmunoBlots to physicians in New York State,” said Dr. Jyotsna Shah, President of IGeneX. “Doctors use to call me and say ‘my patients have Lyme-like symptoms. Why are your tests negative?’ We now know that their symptoms might have been due to TBRF Borrelia infection. These new TBRF ImmunoBlot tests will help patients in this group, as well as patients with Lyme and TBRF Borrelia mixed infections.”

The accuracy of the TBRF ImmunoBlot has been established. The specificity is 98.5% for IgM and IgG based on a study performed on 212 well characterized samples, of which 50 were provided by the CDC. Additionally, the TBRF ImmunoBlots can detect the full spectrum of disease: early, active and late-stage disease.

For more information on IGeneX and the TBRF ImmunoBlot tests, please visit

About IGeneX
For over 25 years, IGeneX has been at the forefront of research and development of diagnostic testing for Lyme disease, TBRF, Bartonella, and other tick-borne diseases. IGeneX arms its talented scientists with the most cutting-edge technology available to enable them to find new solutions that challenge the status quo of testing for Lyme and associated tick-borne diseases. The mission of IGeneX is to aid practitioners in their diagnosis of tick-borne illnesses by providing the most comprehensive testing possible. Learn more at:

Media Contact:
Joseph Sullivan 


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More on Relapsing Fever:

Wormser’s Junk Science, Deliberate Avoidance of Chronically Ill Patients & A Letter Him Asking Why

Wormser’s junk science and deliberate avoidance of the horribly disabled

NOV 13, 2019 — 

Editorial censorship over the past thirty years has kept the truth from the public as patient testimony all across America (and the globe) is describing a disease that is destroying lives, ending careers while leaving its victim in financial ruin. This petition site is a clearinghouse of evidence to be used in current and future litigation over the deliberate mishandling of Lyme disease by the academics that have controlled the narrative, government health officials who have aligned themselves and financed the deception with US taxpayer dollars and the editors of journals who continue to conceal the truth.

There is no way my letter to the editor below will see the light of day so it is being published here for everyone to see …….

When evidence based medicine has been spun to fit bias agendas and the patient voice has been intentionally ignored who investigates the dishonest science?

-Carl Tuttle

Letter to: Dr. Joerg Heber with copy to The Tick-borne Disease Working Group and Dr. Anthony Fauci who continues to fund Wormser’s “JUNK SCIENCE”
———- Original Message ———-
Date: November 12, 2019 at 8:28 AM
Subject: Post-treatment Lyme disease symptoms score: Developing a new tool for research.


Post-treatment Lyme disease symptoms score: Developing a new tool for research.

Turk SP, Lumbard K, Liepshutz K, Williams C, Hu L, Dardick K, Wormser GP, Norville J, Scavarda C, McKenna D, Follmann D, Marques A


“Some patients have residual non-specific symptoms after therapy for Lyme disease, referred to as post-treatment Lyme disease symptoms or syndrome, depending on whether there is functional impairment.”

Nov 12, 2019

1160 Battery Street
Koshland Building East, Suite 225
San Francisco, CA 94111
Attn: Joerg Heber, Editor-in-Chief (PhD in Semiconductor Physics)

Dear Dr. Heber,

As the Editor-in-Chief of a scientific journal you should be well aware of the following: (Taken from the attached JAMA letter to the editor published Dec 18, 2018)

“It is well known that untreated streptococcal pharyngitis can progress to rheumatic fever, causing irreversible heart damage. Untreated syphilis leads to progressive disability and dementia, and untreated human immunodeficiency virus infection progresses to AIDS with significant disability and death. What happens to a patient with Lyme disease who goes months, years, or decades before diagnosis because of a false-negative serological test result?”

Wormser et al do not discuss the consequences of untreated Lyme disease in their PLOS published paper. Why do you think that is the case Dr. Heber?

Post Treatment Lyme Disease Syndrome after early treatment and untreated late stage Lyme of months, years or decades are two distinctly different disease states with the later going unrecognized for over three decades. The absence of a bulls-eye rash after tick bite allows patients to progress to severe neurological disease instead of obtaining a prompt diagnosis and early treatment. Purposely avoiding the advanced stage of disease hides the horribly disabled and anyone unable to see this is somewhat naïve. Avoiding the seriously disabled Lyme patient population hides the severity of the disease as exposed in the “Under our Skin” documentary.

Under Our Skin – Extended Trailer (5min, please watch the video)

For the past three decades, Lyme disease has been portrayed as hard to catch and easily treated  [1] while those who control the narrative (Through editorial censorship) refuse to recognize this pathogen as an antibiotic resistant/tolerant superbug by suppressing evidence of persistent infection.  [2] This misclassification has all but eliminated government funding that should have been equal to or greater than AIDS or Zika which are also life-altering/life-threatening infections in need of cures.

For example: (in reference to persistent infection)

I would like to point out the following case study from Stony Brook Lyme Clinic. I understand the patient received thirteen spinal taps, multiple courses of IV and oral meds, and relapsed after each one, proven by CSF antigens and/or PCR. The only way this patient (said to be a physician) remained in remission was to keep her on open ended clarithromycin- was on it for 22 months by the time of publication.

Seronegative Chronic Relapsing Neuroborreliosis.

Lawrence C.a · Lipton R.B.b · Lowy F.D.c · Coyle P.K.d  aDepartment of Medicine, bDepartment of Neurology, and cDivision of Infectious Diseases, Albert Einstein College of Medicine, and dDepartment of Neurology, State University of New York at Stony Brook, New York, NY., USA
Eur Neurol 1995; 35:113–117  (DOI:10.1159/000117104)


We report an unusual patient with evidence of Borrelia burgdorferi infection  who experienced repeated neurologic relapses despite aggressive antibiotic therapy. Each course of therapy was associated with a Jarisch-Herxheimer-like reaction. Although the patient never had detectable free antibodies to B. burgdorferi in serum or spinal fluid, the CSF was positive on multiple occasions for complexed anti-B. burgdorferi antibodies, B. burgdorferi nucleic acids and free antigen.

Duke University Oncologist Dr. Neil Spector required a heart transplant after his infection was left untreated for four years while serology was repeatedly negative for Lyme disease.
Gone in a Heartbeat – A Physician’s Search for True Healing

Patient testimony all across America (and the globe) is describing a disease that is destroying lives, ending careers while leaving its victim in financial ruin.

The truth about this devastating disease has been kept from the public for 43 years and there are no  Public Service  Announcements informing the public that you could become horribly disabled  [3]  [4] or die  [5] from Lyme disease.

A worldwide community of physicians has been influenced by the ongoing disinformation campaign aimed at promoting the idea that Lyme is little more than a nuisance disease as health agencies across the globe are blindly following what has been deceitfully established here in the U.S. The academics that controlled the narrative for the past three decades have been named as defendants in a Texas District Court racketeering lawsuit and that fact is missing from the conflicts of interest statement in the Wormser published PLOS article.  Why is that Dr. Heber?

Court Document:

We are dealing with a life-altering/life-threatening infection with faulty/misleading antibody tests, inadequate treatment, no medical training and absolutely no disease control; a public health disaster.

And once again we see  Wormser fixated on the acute stage of disease after early treatment as he continues to believe that he has pulled the wool over the eyes of the reader and medical community.

When evidence based medicine has been spun to fit bias agendas and the patient voice has been intentionally ignored who investigates the dishonest science?

A response to this inquiry is required.

Respectfully submitted,

Carl Tuttle

Lyme Endemic Hudson, NH
Cc: Iratxe Puebla, Senior Managing Editor
Michelle Dohm, Managing Editor, Editorial Board Services
George Vousden, Senior Editor
Meghan Byrne, Senior Editor, Team Manager
Anthony S. Fauci, M.D., NIAID Director

References: (Please read them!)

1.  Lyme Disease Is Hard to Catch And Easy to Halt, Study FindsNew York Times By GINA KOLATA Published: June 13, 2001

Excerpt: But some who have treated hundreds of patients with long-term antibiotics, like Dr. Sam L. Donta of Boston University Medical Center, were not convinced. The antibiotics in the studies were not given for a long enough time, Dr. Donta said, and he would have chosen different ones. Perhaps all that the studies show, he said, is ”that this particular treatment doesn’t work.”

2.   Peer Reviewed Evidence of Persistence of Lyme Disease Spirochete Borrelia burgdorferi and Tick-Borne Diseases after the mandated one-size-fits-all IDSA treatment approach:(700 articles)

3.   Latent Lyme Disease Resulting in Chronic Arthritis and Early Career Termination in a United States Army Officer(Published: 06 March 2019)

4.   Nicole Malachowski: Unfit for Duty from Debilitating Tick-Borne Disease

5.    Deaths From Lyme Disease Compiled by: John D. Scott, Research Scientist 17 April 2018

Today’s letter to Dr. Gary Wormser of New York Medical College

NOV 14, 2019 — 

There has never been a response to any of my inquiries addressed to Dr. Wormser….I wonder why? A copy of this letter was sent to the lead attorney of the current Texas RICO lawsuit.

———- Original Message ———-
To: gary wormser <>,
Date: November 14, 2019 at 8:48 AM
Subject: Re: Post-treatment Lyme disease symptoms score: Developing a new tool for research.

Nov 14, 2019

Division of Infectious Diseases,
New York Medical College,
Valhalla, NY 10595
Attn: Gary P. Wormser, MD

Dr. Wormser,

As an Infectious Disease Specialist I would like to ask you a few questions that I hope you could take the time to answer:

1. Does untreated strep throat lead to rheumatic fever causing irreversible heart damage?

2. Does untreated human immunodeficiency virus infection progresses to AIDS with significant disability and death?

3. Does untreated syphilis lead to progressive disability and dementia?

4. Does untreated Lyme disease produce sudden death with no warning signs; [1,2,3,] heart damage requiring transplant, [4] paralysis with seizures, [5] lymphoma [6] and persistent infection after antibiotic treatment [7, 8,9,10,11] along with congenital transmission [12] and ability to create wheelchair bound patients [13]?
Your thirty year fixation on the acute stage of disease (with bulls-eye rash) after early treatment gives the impression that you have disregarded the consequences of untreated Lyme disease which leaves the patient horribly disabled similar to the other examples I have presented.

I believe you have coined the phrase “aches and pains of daily living” when patients experience a return of symptoms after the one-size-fits-all IDSA treatment mandate.

“Post Treatment Lyme Disease Syndrome” after early treatment and untreated late stage Lyme of months, years or decades are two distinctly different disease states with the later going unrecognized for over three decades. Patients who have had a prolonged exposure to the pathogen are almost always incapacitated.

5. So what is your motivation for disregarding the consequences of untreated Lyme disease? Is it because the outcome of untreated Lyme doesn’t match the well-established dogma that Lyme is a simple nuisance disease; hard to catch and easily treated, which you helped to establish?

We have a disease that is wreaking havoc all across America (and the world) while you remain focused on the early stage of disease as indicated in your latest PLOS publication; shameful indeed.   

Misclassification has pigeonholed Lyme disease into a low-risk and non-urgent health issue which has all but eliminated adequate government funding for a disease capable of long term disability and death.

A response to this inquiry is requested.

Carl Tuttle

Lyme Endemic Hudson, NH

References: (Tip of the iceberg)

1. Cardiac Tropism of Borrelia burgdorferi: An Autopsy Study of Sudden 
Cardiac Death Associated with Lyme Carditis. (March 2016)


“Fatal Lyme carditis caused by the spirochete Borrelia burgdorferi rarely is identified. Here, we describe the pathologic, immunohistochemical, and molecular findings of five case patients.”

2. CDC Case Study #1: Three Sudden Cardiac Deaths Associated with Lyme Carditis:

3. CDC Case Study #2: A case report of a 17-year old male with fatal Lyme carditis

4. Professor Neil Spector: Duke physician uses near-death experience to encourage patient self-advocacy

Dr Neil Spector from Duke University required a heart transplant after his Lyme disease went undiagnosed for four years.

5. Nashua Mom in the ‘Lyme Light’ on Katie Couric Show

Fifth-grade teacher Kelly Downing was paralyzed from the neck down and interviewed by Katie Couric.

6Infection by Borrelia burgdorferi and cutaneous B-cell lymphoma (Cancer)

Specific DNA sequences of Borrelia burgdorferi were identified in cutaneous lesions from 9 patients (follicle center lymphoma: 3/20; immunocytoma: 3/4; marginal zone B-cell lymphoma: 2/20; diffuse large B-cell lymphoma: 1/6).

7. Application of Nanotrap technology for high sensitivity measurement of urinary outer surface protein A carboxyl-terminus domain in early stage Lyme borreliosis.

41 of 100 patients under surveillance for persistent LB in an endemic area were positive for urinary OspA protein after antibiotic treatment.

8. Culture evidence of Lyme disease in antibiotic treated patients living in the Southeast.

Rudenko and colleagues reported culture confirmation of chronic Lyme disease in 24 patients in North Carolina, Florida, and Georgia. All had undergone previous antibiotic treatment.

9. DNA sequencing diagnosis of off-season spirochetemia with low bacterial density in Borrelia burgdorferi and Borrelia miyamotoi infections.

Faulty/misleading antibody tests landed a sixteen year old male in a psychiatric ward when his lab results did not meet the CDC’s strict criteria for positive results. His Western blot had only four of the required five IgG bands. Subsequent DNA sequencing identified a spirochetemia in this patient’s blood so his psychiatric issues were a result of neurologic Lyme disease misdiagnosed by antiquated/misleading serology. This patient was previously treated with antibiotics.

10. Granulomatous hepatitis associated with chronic Borrelia burgdorferi infection: a case report

The patient had active, systemic Borrelia burgdorferi infection and consequent Lyme hepatitis, despite antibiotic therapy.

11. Scotty Shelton and Persistent Infection in Saginaw MN

“Scotty’s brain (cerebral cortex) was positive for Borrelia burgdorferi and Borrelia myamotoi, his testicle is positive for Bb. We are now testing other tissues. Seven years of antibiotics and 3.5 years of natural treatments (along with antibiotics) and he was highly highly positive.”

12. Congenital Transmission of Lyme/TBD

13. Wheelchair-Bound Girl Calls Blessing By Pope Francis ‘Most Precious Moment Of My Life

NEW YORK (CBSNewYork) — A 12-year-old girl who has been confined to a wheelchair since being diagnosed with Lyme disease said meeting Pope Francis as he arrived in New York Thursday was “the most precious moment of my life.”


The Difficulty & Importance of Asking For Help

black and white photo of handing holding a wooden heart. The heart is the only part that has color

by Jennifer Crystal


Last winter an acquaintance sustained an injury that made it difficult for her to do any heavy lifting. She managed well enough until a big snowstorm hit her area. Her doctor warned her not to shovel her driveway. But because she lived alone, she was either going to have to ask someone else to shovel or stay snowed in.

The solution here seems simple, but it’s actually quite difficult for anyone who is a natural helper”. As individuals, we are happy to provide help, but were not very good at receiving it, and even worse when it comes to asking for it. To ask for help is to show one’s vulnerability; it is to relinquish some control and recognize ones own limitations. And that makes a lot of us uncomfortable.

A little more than a decade ago, when I was in the throes of a Lyme relapse, I was in a similar situation. I was living alone in Vermont when the state got walloped with more than two feet of snow. Stuck on my couch, barely able to address my basic needs, I wondered how I would ever dig myself out. I saw neighbors huffing and puffing as they unearthed their vehicles and driveways. I hardly knew any of them. How could I possibly ask them for help?

I resigned myself to staying indoors. But my symptoms worsened, and my doctor said I needed to start a new antibiotic. That meant going to the pharmacy, which meant digging out my car.

I paced around my apartment, trying to figure out what to do. I did not have the physical strength to shovel, no matter how badly I wanted to do it or how hard willed I believed myself. I had no choice but to ask for help; I didnt like being in that position. It brought on feelings of shame and guilt that have often accompanied me on my Lyme journey.

I called my mom. She lived out of state and couldnt physically help, but she suggested I call an old college friend who lived in my town.

I cant do that!,” I said. He has a family to take care of! Im sure hes busy digging out their own cars. He works full time, too. How can I give him this big task on top of everything else hes got going on?”

I see now that I was projecting my own fears on the response of my friend. I was trying to think of all the ways my request could be a burden on him, without allowing him a say in the matter. I assumed hed be annoyed or put out, but those assumptions stemmed from my own discomfort.

In the past, I’d had the experience of asking the wrong person for help. Once during my illness, I planned a lunch with former colleagues. I knew I would have more energy if I didnt have to drive myself to the restaurant, so I asked a colleague who lived nearby if she could pick me up.

Thats really going to be tough,” she replied. I have a lot of other things going on that morning, and picking you up would be an extra ten minutes out of my way.” Id had to swallow my pride and when my request was rejected, I felt embarrassed and ashamed.

In fact, Id simply asked the wrong person; that sometimes happens, just as sometimes Im not available to help others as I’d like to. My former colleague wasnt very understanding when it came to illness. Some people aren’t. Other people are, though, and there was no reason to believe my old friend wouldnt be compassionate.

Finally, I bit the bullet and called. Of course Ill help,” he said without hesitation. Give me an hour to finish shoveling off our cars, and Ill be right over.” An hour later there he was, heaving piles of snow with the strength of a lumberjack, and an hour later he was finished. What seemed an insurmountable task to me had truly been no big deal to him, and he said so when I offered to pay him or at least make him some hot cocoa. Happy to help,” he said. Let me know if theres anything else you need.”

I relayed this story to my injured acquaintance who was also snowed in. Together we created a shortlist of people she could ask for help.

A few days later I called to check on her. She was sacked out on her couch, her injury worse, because shed never called anyone. She had insisted on doing the shoveling herself. She didnt want to appear weak, she confided. And besides, no one could shovel her driveway as well as she could.

I understood where she was coming from because Id once been there myself. Over time, though, Ive realized that asking for help is not a sign of weakness; it actually takes a lot of strength. I also learned that its okay to release control over external matters from time to time, like how well the driveway will be shoveled, in order to focus on one’s precious health.

Doing so will allow you to get stronger faster, so you can get back to helping others. Until then, you can still be a natural helper from bed, just by being a good friend, a good listener, and a confident presence. If it feels overwhelming right now, thats okay; it means that you need to take this time to focus on yourself and get well, so that one day, you can pay it forward.

jennifer crystal_2Jennifer Crystal is a writer and educator in Boston. Her memoir One Tick Stopped the Clock is forthcoming. Contact her at

Call to Challenge Minnesota Medical Review Board on Ending 5-Year Moratorium to Not Persecute Lyme Doctors


Thomas Grier
902 Grand View Ave
Duluth, MN, 55812

Attention – Dr. Elizabeth Maloney, Lorraine Johnson, Pat Smith, Phyliss Mervine,

CC. Dr. Eva Sapi, Dr. Alan MacDonald, Dr. Kenneth Leigner, Dr. Robert Bransfield, Dr. Brian Fallon.…/the-lyme-wars-are-not…/

Dear Lyme disease patient advocates and researchers,

The recent decision of the Minnesota Medical Review Board (MRB) to end their five-year moratorium to not persecute Lyme disease doctors who treat aggressively with antibiotics beyond the IDSA recommended guidelines, is a historic decision that cannot go unchallenged.

During the five-year moratorium in MN, which banned the persecution of doctors who treat tick-borne illnesses aggressively with antibiotics, the MN MRB members only cited a single patient antibiotic study for their actions. This study mostly simply looked at patient’s symptoms after antibiotic treatment.

This and other similar studies relied on the use of defective blood tests like the B-31 based ELISA serology tests, which we know only detects just one Borrelia species. The experts refusal to accept that we are now dealing with over a dozen human pathogenic Borrelia-Lyme species continues to be intolerable.

It was the hard work of several people and groups working together almost 10 years ago to get the MRB to originally agree to the moratorium to allow MN doctors to continue to treat Lyme disease as they see fit. Many of these same advocates have worked on political efforts to protect doctors and patients. Now it is time that we combine politics with PATHOLOGY.

I am asking our most influential Lyme activist groups and researchers to work together to petition our legislators to force the Minnesota Department of Health to do pathology-based brain studies to look for the persistence of Borrelia in dementia and MS brains using state-of-the-art research tools such as FISH stains, confocal Laser Microscopy, Atomic Force Electron Microscopy and more emerging technologies.

Or at the very least we must create an independent review council to review Lyme-Pathology studies published and unpublished showing persistence of Borrelia post antibiotics, and the persistence of Borrelia in the brain, and heart. A council to bring to the MRB any pathology-based associations to chronic illnesses like dementia or MS.

We all know the cost of untreated illness, but our medical insurance providers only see the cost in terms of treatments, and not the cost of long-term medical care for untreated seronegative neurologic patients.

To achieve the goal of getting a State-paid brain pathology study or a pathology review committee; groups and individuals will have to come together and form a take-action committee to define and refine our goals and to assemble teams to lobby our legislative body, our health department and the MRB.

Such topics as multiple Borrelia species, poor blood-tests, immune system evasion, and immune sequestered sites are all huge topics much too big for non-medical legislators to fully understand without proper navigation.

Please support this effort!

Thomas Grier 218-216-5670



For those just tuning in:

Microbiologist Tom Greer makes some astute observations:

  1. A study which only looks at symptoms is very subjective and certainly should NOT become a mandate on how a doctor can and can not treat
  2. There’s a real problem with a  test which only looks at one borrelia species
  3. We desperately need pathology studies which show pathogen persistence as well as the fact it sequesters in tissues making blood tests nearly worthless
  4. On top of all of these points, advocate Carl Tuttle continues to drill home the point that those diagnosed and treated early that remain with symptoms have a completely different disease process than those who are diagnosed and treated late.  For a great read on this:  According to microbiologist Holly Ahern, when you add both groups together, there’s a whopping 60% of patients going on to develop chronic/persistent symptoms.

Also, this is another great reason to write your Wisconsin representative and tell them to squash Assembly Bill 313 if you haven’t already done so. More Minnesotans are going to be coming to Wisconsin for treatment. The last thing we need is a panel dictating how our doctors diagnose and treat:








FDA Approves Cobas Babesia Test for Individual Blood Donation Testing

Media Release

Basel, 20 September 2019

FDA approves cobas Babesia, Roche’s first whole blood test for donor screening

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the cobas Babesia test for use on the cobas 6800/8800 Systems for individual blood donation testing. This is Roche’s first commercially available whole blood test to screen donations and follows May 2019 FDA-updated industry guidance recommending screening and testing for Babesia, to reduce the risk of transmitting the parasite through transfusions.1

cobas Babesia detects parasites that live in red blood cells. This test is an important advancement because the Babesia parasite cannot be detected in traditional plasma or serum samples. The test is able to detect the four common species of Babesia and employs the new whole blood collection tube, which simplifies Babesia sample preparation by consolidating steps within the tube itself to provide an efficient solution for testing laboratories.

In most cases, the Babesia parasite is transmitted to humans through the bite of an infected tick; however, the parasite can also be transmitted through blood transfusions or from mother to foetus during pregnancy. The parasite infects and destroys red blood cells which can lead to anaemia and related life-threatening complications, particularly in the elderly or otherwise immunocompromised patients. In healthy people, the infection can be asymptomatic, or cause a range of mild flu-like symptoms.

“We are dedicated to helping save patients’ lives by providing advanced solutions to enable the protection of the global blood supply from infectious diseases. With the approval of Roche’s first whole blood test used in blood screening we can help healthcare professionals further diminish potential risks of infection from transfused blood products,” said Thomas Schinecker, CEO Roche Diagnostics. “In addition, we hope to help customers improve their lab efficiency by simplifying sample prep while ensuring maximum detection of infectious pathogens in the blood and the safety of the blood supply for the patients we serve.”

The Roche Blood Safety Solutions offering now provides the most comprehensive testing solution for blood donor screening utilising the fully automated cobas 6800/8800 System. This novel test approval follows the successful launch of the cobas Zika test, which was the first Zika test available for donor screening in the U.S. This new Babesia test expands the menu of tests available for the cobas 6800/8800 Systems for use in U.S. donor screening laboratories. This menu includes cobas MPX, cobas WNV and cobas Zika. In addition, the menu includes cobas DPX2, which is used in testing labs that support plasma fractionators.

About the cobas Babesia test for use on the cobas 6800/8800 Systems

The cobas Babesia test for use on the cobas 6800/8800 Systems is a qualitative in vitro nucleic acid screening test for the direct detection of Babesia DNA and RNA in whole blood specimens from individual human blood donors. It detects the four species of Babesia known to cause disease in humans and can be performed with the other routine blood donor screening tests.

The fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms, providing donor screening laboratories with improved operating efficiency and the flexibility to adapt to changing testing demands. The cobas Babesia test is the latest addition to Roche’s assay menu for donor screening laboratories — which includes cobas MPX, cobas DPX, cobas HEV, cobas WNV, cobas CHIKV/DENV and cobas Zika (US-IVD) — all of which are run on the cobas 6800/8800 Systems. Not all assays are available in all markets.

Since 2014, the cobas 6800 and cobas 8800 Systems have established the new standard for routine molecular testing by delivering fully integrated, automated solutions that serve the areas of donor screening, infectious disease, sexual health, transplant, respiratory and antimicrobial stewardship.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2018 employed about 94,000 people worldwide. In 2018, Roche invested CHF 11 billion in R&D and posted sales of CHF 56.8 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit

All trademarks used or mentioned in this release are protected by law.


For more:

While a current article downplays Babesia in Canada, another article shows it’s much more of a problem than suspected:  This clearly shows there were more than 200 Babesia transfusion-transmissions reported. It also shows you don’t have to reside in an endemic area or travel to an endemic area to get it. The article also clearly points out that the geographic range of ticks is expanding, which means the pathogens they carry will as well.

Minnesota Medical Board Reinstates Sanctions on Controversial Lyme Disease Treatment

Research suggests long-term antibiotics are no better than short term.

JAMES GATHANY – CDC VIA AP  Minnesota is a Lyme hot spot due to the prevalence of black-legged (or deer) ticks that carry the bacteria that causes it.

Doctors who prescribe long-term antibiotic therapy for tick-borne Lyme disease are now at risk for licensing sanctions in Minnesota, a sign that many leaders in the profession regard the therapy as discredited.

The Minnesota Board of Medical Practice earlier this week lifted its decade long moratorium on such actions because of research suggesting that long-term antibiotic therapy offers no benefits over the short-term therapy that most patients receive when their Lyme cases are diagnosed.

Whether the change will result in a wave of disciplinary actions is unclear, because the board only investigates complaints and some doctors might have dropped this form of treatment, said Ruth Martinez, the board’s executive director.
“It’s kind of hard to know because we’re a complaint-driven process,” she said.

Antibiotic therapy for chronic Lyme symptoms became a medical and political controversy in Minnesota in 2010, after the Infectious Diseases Society of America discouraged the practice. The society cited a lack of evidence that it helps, as well as concern that overuse of antibiotics would give rise to drug-resistant bacteria strains.

Some Lyme experts sought legislation to protect the practice because they worried that the society’s stance would give the medical board justification to penalize doctors who believed the treatment worked. The compromise was the board’s moratorium, which it reviewed and extended in 2014, until research adequately addressed the question.

The board this week decided to lift the moratorium based largely on a Dutch study published in 2016 in the New England Journal of Medicine that showed that long-term antibiotic therapy offered no more relief from chronic Lyme symptoms than placebo pills.

Minnesota is a Lyme hot spot due to the prevalence of black-legged (or deer) ticks that carry the bacteria that causes it. The state reported 950 cases last year, plus another 591 probable cases that weren’t confirmed by lab tests.

Known for the bull’s-eye rash that often appears at the infection site, Lyme disease causes fatigue, joint pain and other symptoms. Most patients recover with standard antibiotics within a few weeks, but some suffer lingering symptoms.

The U.S. Centers for Disease Control and Prevention also discourage long-term antibiotic therapy for treatment of these chronic symptoms, noting research that it can cause complications, including an increased risk of future infectious diseases.

While no one spoke in opposition to the board’s decision at its latest meeting, the decision upset some Lyme advocates.

Dr. Elizabeth Maloney of Wyoming, Minn., has created online training for physicians regarding Lyme disease and serves on the treatment subcommittee of the federal Tick-Borne Disease Working Group. She pointed to a separate study showing that long-term antibiotics at least offered benefits to a subgroup of Lyme patients with persistent fatigue.

Doctors with experience in treating Lyme should still be able to use this treatment option when others aren’t working, she said, but she worries that they will now be afraid to do so.

“It becomes an access-to-care issue,” she said, “for these very sick patients.”

Recently, Dr. Cameron asks a very important question about the potential of antibiotic stewardship on delaying treatment for Lyme/MSIDS patients:

“In elderly patients with a diagnosis of UTI in primary care, no antibiotics and deferred antibiotics were associated with a significant increase in bloodstream infection and all-cause mortality compared with immediate antibiotics,” writes Gharbi.

While this study examines the effect of antibiotic stewardship on elderly patients with a UTI, it also raises the question as to the impact of such stewardship programs on treatment delays for patients with Lyme disease.

Netflix Star Talia Jackson on Battling Lyme Disease While Chasing Her Hollywood Dreams: ‘This is a Very Lonely Disease’  Full Article Here

Netflix Star Talia Jackson on Battling Lyme Disease While Chasing Her Hollywood Dreams: ‘This Is a Very Lonely Disease’ 

It’s hard enough being a young woman in showbiz, let alone dealing with a debilitating illness that causes pain, fatigue and spontaneously passing out on set—the toll of which can surface in crippling anxiety and depression.

But for Netflix’s Family Reunion star, Talia Jackson, spending her teenage years learning to live with Lyme disease came with a nasty twist: Her mom, Kelly, accompanied her to the doctor and recognized the same symptoms Talia was describing in herself, leading to her also being diagnosed with the bacterial illness….(See full article in link)