Archive for the ‘Babesia’ Category

FDA Approves Cobas Babesia Test for Individual Blood Donation Testing

https://www.roche.com/media/releases/med-cor-2019-09-20.htm

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 www.roche.com.

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

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For more:  https://madisonarealymesupportgroup.com/category/babesia-treatment/

https://madisonarealymesupportgroup.com/2019/09/05/babesia-subverts-adaptive-immunity-and-enhances-lyme-disease-severity/

https://madisonarealymesupportgroup.com/2019/08/25/babesia-microti-borrelia-burgdorferi-coinfection/

https://madisonarealymesupportgroup.com/2018/10/11/babesia-found-in-patient-with-persistent-symptoms-following-lyme-treatment/

While a current article downplays Babesia in Canada, another article shows it’s much more of a problem than suspected:  https://madisonarealymesupportgroup.com/2019/08/21/prevalence-of-babesia-in-canadian-blood-donors-june-october-2018/

https://madisonarealymesupportgroup.com/2019/07/11/characteristics-of-transfusion-transmitted-babesia-microti-american-red-cross-2010-2017/  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.

Live Q & A Webinar: Lyme Coinfections 11/19

Live Webinar: Ask Dr. Rawls
Join Dr. Bill Rawls for this new LIVE WEBINAR on Tuesday, November 19th, at 8pm ESTfor a new LIVE Q&A webinar about Lyme Disease Coinfections.

If you have questions about diagnosing and treating common Lyme coinfections including Epstein-Barr, Bartonella, Mycoplasma, Babesia, and Candida, you don’t want to miss this webinar.

Topics covered by Dr. Rawls during the webinar will include:

  • What are the telltale signs of a Lyme coinfection?
  • Do you need to know which coinfection(s) you have before seeking treatment?
  • Are there any reliable tests for Lyme and coinfections?
  • What are the best herbal and natural remedies for Lyme coinfections?
  • How can you tell for certain when Lyme and coinfections are gone?
  • Numerous other insights and answers throughout the live Q&A with Dr. Rawls

Submit your top Lyme coinfection questions after you register, and Dr. Rawls will try to answer as many as possible.

Plus, we will announce an exclusive offer for webinar attendees.

Reserve Your Seat Now »
We look forward to seeing you there!

P.S. If you have questions about the webinar, please reply to this email or call us at 800-951-2414.

 

Ticks Carrying Multiple Diseases Are ‘Taking Over’ Long Island

https://nypost.com/2019/09/17/ticks-carrying-multiple-diseases-are-taking-over-long-island/

Ticks carrying multiple diseases are ‘taking over’ Long Island

Lyme disease isn’t the only awful illness ticks are capable of transmitting.

Superticks can carry up to four different diseases at a time, including Lyme disease. And these insects of mass destruction are becoming especially abundant in Long Island, according to a study published this month in the journal mBio.

“They’ve kind of taken over,” co-author Rafal Tokarz tells The Post.

It means that one bite could potentially give a person Lyme disease as well as illnesses such as potentially life-threatening babesiosis and anaplasmosis. A quarter of the ticks examined in the study had the ability to transmit more than one disease.

“Most people think of Lyme disease when they think of [tick-borne illnesses], and that’s justified, but in Suffolk County alone, ticks can carry four other pathogens,” says Tokarz, an assistant professor of epidemiology at the Center for Infection and Immunity at Columbia’s Mailman School of Public Health.

“Very often, we find sometimes two, even three, of these pathogens [in the same tick],” he says.

He and his fellow researchers are also growing increasingly worried about the Lone Star tick, a species whose saliva can cause an allergic reaction to meat. The tick has migrated in recent years from the southern part of the United States up to Long Island and New England.

One woman in Missouri developed the allergy after a tick bite four years ago — and only just learned it was due to the Lone Star tick.

“It got to the point where my stomach would swell up; I was vomiting,” Kristie Downen said. “The rashes were real bad. It was getting to the point [I told doctors], ‘You’re missing something — I’m still dying.’ ”

There’s currently no treatment for the meat allergy the Lone Star tick can cause, Tokarz says. But, he adds, doctors now need to start testing people who were recently bitten for multiple tick-borne diseases.

“This tick, in particular, has become very troublesome,” Tokarz says. “Thirty, 40 years ago, you hardly ever found them on Long Island. Now they’ve become extremely abundant.”

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**Comment**

The number of diseases currently transmitted by ticks is 20 and counting. This article states it’s 16 within the U.S. but these numbers are continually influx with new pathogens continually being discovered:

https://madisonarealymesupportgroup.com/2019/08/09/ticks-are-worldwide-we-all-need-to-learn-more-about-them/

https://madisonarealymesupportgroup.com/2019/07/27/ticks-spread-plenty-more-for-you-to-worry-about-beyond-lyme-disease/

https://madisonarealymesupportgroup.com/2017/05/01/co-infection-of-ticks-the-rule-rather-than-the-exception/

https://madisonarealymesupportgroup.com/2019/09/18/more-than-lyme-tick-study-finds-multiple-agents-of-tick-borne-diseases/

https://madisonarealymesupportgroup.com/2018/10/30/study-shows-lyme-msids-patients-infected-with-many-pathogens-and-explains-why-we-are-so-sick/

Excerpt:

For the first time, Garg et al. show a 85% probability for multiple infections including not only tick-borne pathogens but also opportunistic microbes such as EBV and other viruses.

“Our findings recognize that microbial infections in patients suffering from TBDs do not follow the one microbe, one disease Germ Theory as 65% of the TBD patients produce immune responses to various microbes.”

The poly microbial issue isn’t even on the radar of most doctors, and this is why the CDC recommendation of 21 days of doxycycline is an absolute farce.

According to this review, 83% of all commercial tests focus only on Lyme (borrelia), despite the fact most of us are infected with more than one microbe.  The review also states it takes 11 different visits to 11 different doctors, utilizing 11 different tests to be properly diagnosed.  https://www.news-medical.net/news/20181101/Tick-borne-disease-is-multiple-microbial-in-nature.aspx?

When will things change?

 

 

Babesia Duncani Emerges in Eastern U.S. & Poses Treatment Challenges

https://danielcameronmd.com/wp-content/uploads/kalins-pdf/singles/babesia-duncani-emerges-in-eastern-u-s-and-poses-treatment-challenges.pdf  Read entire article here.

New research indicates, however, there may no longer be a division of babesial strains between the East Coast and the West Coast. In their article “Babesia microti – Borrelia burgdorferi Co-infection,” Parveen reports that B. duncani has now been identified in eastern USA and Canada.¹

“Since B. duncani is widespread in Canada, its southern spread into northeastern U.S., an area already endemic for Lyme disease, makes co-infections with B. duncani and B. burgdorferi [Lyme disease] a possibility that needs to be carefully investigated.”

“While this review focuses on co-infection with B. microti and B. burgdorferi, there is some evidence that co-infections with a different Babesia species, B. duncani, and B. burgdorferi may be more common than previously suspected,” writes Parveen.

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**Comment**

This article exposes a crucial issue that mainstream medicine is still in the dark ages on – ticks are coinfected and so are we.  This is not straight-forward.  The very thought that doxycycline is going to cover this hodgepodge of pathogens is truly asinine if you study the research:  https://madisonarealymesupportgroup.com/2019/02/22/why-mainstream-lyme-msids-research-remains-in-the-dark-ages/

https://madisonarealymesupportgroup.com/2017/05/01/co-infection-of-ticks-the-rule-rather-than-the-exception/

https://madisonarealymesupportgroup.com/2019/08/25/babesia-microti-borrelia-burgdorferi-coinfection/

https://madisonarealymesupportgroup.com/2019/09/05/babesia-subverts-adaptive-immunity-and-enhances-lyme-disease-severity/

https://madisonarealymesupportgroup.com/2018/10/11/babesia-found-in-patient-with-persistent-symptoms-following-lyme-treatment/

https://madisonarealymesupportgroup.com/2018/10/30/study-shows-lyme-msids-patients-infected-with-many-pathogens-and-explains-why-we-are-so-sick/

I could literally go on and on to infinity – but you get the point – Lyme/MSIDS patients are rarely infected with just Lyme which is why testing is a bit of a joke as well as the mono-therapy of doxycycline.  It takes savvy, education, and experience to treat this complex illness that is literally killing people – or making them want to die.

If your doctor is open-minded (a rare quality these days), please attempt to give them continuing education information that could revolutionize the way patients are being treated:

https://madisonarealymesupportgroup.com/2018/06/06/lyme-education-for-healthcare-professionals/

https://madisonarealymesupportgroup.com/2018/02/19/calling-all-doctors-please-become-educated-regarding-tick-borne-illness-heres-how/

 

More Than Lyme: Tick Study Finds Multiple Agents of Tick-borne Diseases

NEWS RELEASE 

More than Lyme: Tick study finds multiple agents of tick-borne diseases

COLUMBIA UNIVERSITY’S MAILMAN SCHOOL OF PUBLIC HEALTH

IMAGE
IMAGE: THREE PRIMARY HUMAN-BITING TICK SPECIES PRESENT ON LONG ISLAND WERE EXAMINED IN THIS STUDY. LEFT — BLACKLEGGED TICK ALSO KNOWN AS THE DEER TICK, MIDDLE — THE AMERICAN DOG TICK,… view more 

CREDIT: SANTIAGO SANCHEZ-VICENTE, STONY BROOK UNIVERSITY

In a study published in mBio, a journal of the American Society for Microbiology, Jorge Benach and Rafal Tokarz, and their co-authors at Stony Brook University and Columbia University, reported on the prevalence of multiple agents capable of causing human disease that are present in three species of ticks in Long Island.

Tick-borne diseases have become a worldwide threat to public health. In the United States, cases more than doubled, from 22,000 in 2004 to more than 48,000 in 2016, according to the U.S. Centers for Disease Control. Tick-borne diseases range from subclinical to fatal infections with disproportionate incidence in children or the elderly. Moreover, some infections can also be transmitted by blood transfusions and cause severe disease in patients with underlying disorders. While public attention has focused on Lyme disease, in recent years, scientists have uncovered evidence that ticks can carry several different pathogens capable of several different tick-borne diseases, sometimes in a single tick.

In the new study, researchers collected ticks from multiple locations throughout Suffolk county in the central and eastern part of Long Island, where seven diseases caused by microbes transmitted by ticks are present. In total, they examined 1,633 individual ticks for 12 separate microbes. They found that more than half of the Ixodes (deer ticks) were infected with the Lyme disease agent, followed by infections with the agents of Babesiosis and Anaplasmosis. Importantly, nearly one-quarter of these ticks are infected with more than one agent, resulting in the possibility of simultaneous transmission from a single tick bite.

Notably, the lone star tick, a species originating from the southern U.S., has expanded its range, possibly fueled by climate change. This study documents that the invasive lone star tick is abundant in Long Island, and that it is a very aggressive tick that can transmit a bacterium that causes a disease known as Ehrlichiosis. The lone star tick has also been implicated in cases of a novel form of meat allergy, and the immature stages can cause an uncomfortable dermatitis.

“Polymicrobial infections represent an important aspect of tick-borne diseases that can complicate diagnosis and augment disease severity,” says corresponding author Jorge Benach, PhD, Distinguished Professor at the Department of Microbiology and Immunology at the Renaissance School of Medicine at Stony Brook University. “Some of the polymicrobial infections can be treated with the same antibiotics, but others require different therapies, thus enlarging the number of drugs to treat these infections.”

“In evaluating tick-borne infection, more than one organism needs to be considered,” says senior author Rafal Tokarz, PhD, assistant professor of epidemiology in the Center for Infection and Immunity at the Columbia Mailman School of Public Health, and a graduate of the Department of Microbiology and Immunology at Stony Brook University. “This study emphasizes the need to focus on all tick-borne diseases, not just Lyme.”

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The first author is Santiago Sanchez, a post-doctoral fellow in the Department of Microbiology and Immunology at Stony Brook University. Teresa Tagliafierro from Columbia and James Coleman from Stony Brook are co-authors of the study.

This study was funded by a grant from the National Institutes of Health to Benach. Support was also provided by the Island Outreach Foundation in Blue Point, NY, to the Stony Brook Renaissance School of Medicine. Support from the Steven & Alexandra Cohen Foundation (CU18-2692) was provided to Tokarz.

 

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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**Comment**

Again, climate change has nothing to do with tick proliferation and disease spread: https://madisonarealymesupportgroup.com/2018/08/13/study-shows-lyme-not-propelled-by-climate-change/

https://madisonarealymesupportgroup.com/2018/11/07/ticks-on-the-move-due-to-migrating-birds-and-photoperiod-not-climate-change/

https://madisonarealymesupportgroup.com/2019/06/17/ontario-public-health-officials-called-out-on-shoddy-biased-research-utilizing-an-erroneous-climate-change-model-to-program-a-futuristic-tick-problem/

https://madisonarealymesupportgroup.com/2018/11/17/uw-madison-phd-in-ecological-climatology-climate-change-computer-models-fudged-except-russian-model/  Dr. Patrick Michaels, director of the Center for the Study of Science at the Cato Institute, provides insight into the debate over climate change and the political games played to create policy.

Political games surrounding Lyme/MSIDS have gone on long enough. Do research on important issues that will help patients.