Archive for the ‘Testing’ Category

Milford Pathologist Fires Broadside at CDC Motion to Discuss

Milford Conn. Pathologist Fires Broadside at CDC Motion to Dismiss

Carl Tuttle
Hudson, NH
AUG 15, 2018 —

2044 Bridgeport Avenue
Milford, CT 06460
August 15, 2018
Media Contact: Kevin Moore, 203-788-8497


Milford Conn. Pathologist Fires Broadside at CDC Motion to Dismiss in Groundbreaking $57.1 Million Lyme Disease Lawsuit

Demonstrates that CDC relied on “unreliable” Wikipedia as source to discredit Dr. Lee

Milford, Conn… Sin Hang Lee, M.D., the Connecticut pathologist who, in May, filed a $57.1 million lawsuit against the Centers for Disease Control, in a legal opposition to the CDC’s motion to dismiss his lawsuit, informed the U.S. Court of Federal Claims, that the CDC had relied on unverifiable, non-peer reviewed Wikipedia as a source for informational support to back its motion to dismiss.

To suppress direct detection tests for Lyme disease,” said Dr. Lee, referring to the Sanger DNA sequencing testing method that he employs, and, which is at the heart of his lawsuit, “the CDC is willing to exhaust all of its administrative remedies. When its patented metabolomics technology could not stop Sanger sequencing in science, the CDC told its lawyers to look up Wikipedia for help in a motion to dismiss my lawsuit.”

In 2013, after testing two panels of Lyme disease reference serum samples from the CDC by Sanger sequencing, Dr. Lee informed the CDC that some of the archived serum samples taken from patients with Lyme disease in fact were positive for Borrelia miyamotoi and a novel unnamed relapsing fever borrelia, and published the data in a peer-reviewed article. Years later, the CDC claimed in social media that Dr. Lee published “inconsistent results” ( ) while promoting its own, newly patented, unproven metabolomics technology for diagnosis of Lyme disease.

In order to deny the facts that clinical Lyme disease may be caused by a diversity of borrelial strains of bacteria, the CDC instructed its lawyers to quote Wikipedia, an online encyclopedia with no peer review, as the alternative science to discredit Dr. Lee’s work in the U.S. Court of Federal Claims. The CDC attorneys then filed the following with the U.S. Court of Federal Claims:

“However, Borrelia miyamotoi is not a causative agent of Lyme disease. Wikipedia, miyamotoi p. 1 (“Although infection [with Borrelia miyamotoi] can cause some similar symptoms [as Lyme disease] including fever, headache, fatigue, and muscle aches, acute Lyme disease often presents with rash, while infection with B. miyamotoi does not; it remains unclear whether B. miyamotoi causes a relapsing fever syndrome”).

In the PLAINTIFF’S RESPONSE TO MOTION TO DISMISS filed on August 13, 2018, Dr. Lee’s attorney, Mary Alice Moore Leonhardt, countered with the following statement:

“The Defendant relied on the inherently unreliable website Wikipedia in its attempt to discredit Dr. Lee, rather than the CDC’s own data. The CDC expressly acknowledges that Borrelia miyamotoi causes hard tick relapsing fever and Borrelia miyamotoi infection causes fever, chills and headache which are common symptoms in Lyme disease, and may cause skin rash in about 8% of the patients (4/51). (CDC, Borrelia miyamotoi Disease, available at
CDC, B. miyamotoi, available at Thus, Dr. Lee’s test results detected the presence of two tick-borne illnesses, including Lyme disease and a disease that presents in similar ways to Lyme disease. These results were 100% accurate as confirmed through the DNA sequencing with the Gene Bank.”
The CDC should come out to debate the science and technology in direct detection testing for the diagnosis of Lyme disease instead of hiding behind a wall of lawyers and Wikipedia encyclopedia,” said Dr. Lee. “Accurate diagnosis of Lyme borreliosis must not be stopped by CDC lawyers.”

* The official documents with Appendix filed in the U.S. Court of Federal Claims can be accessed through the Drop Box. Complete filing here:

Milford Molecular Diagnostics Laboratory:  
Milford Medical Laboratory offers the first reliable DNA test for Lyme disease bacteria and B. miyamotoi, the spirochete causing a Lyme disease-like infection.


Bbsl Infected Ticks in Canadian Songbirds

Far-Reaching Dispersal of Borrelia burgdorferi Sensu Lato-Infected Blacklegged Ticks by Migratory Songbirds in Canada.

Scott JD, et al. Healthcare (Basel). 2018.


Lyme disease has been documented in northern areas of Canada, but the source of the etiological bacterium, Borrelia burgdorferi sensu lato (Bbsl) has been in doubt. We collected 87 ticks from 44 songbirds during 2017, and 24 (39%) of 62 nymphs of the blacklegged tick, Ixodes scapularis, were positive for Bbsl. We provide the first report of Bbsl-infected, songbird-transported I. scapularis in Cape Breton, Nova Scotia; Newfoundland and Labrador; north-central Manitoba, and Alberta. Notably, we report the northernmost account of Bbsl-infected ticks parasitizing a bird in Canada. DNA extraction, PCR amplification, and DNA sequencing reveal that these Bbsl amplicons belong to Borrelia burgdorferi sensu stricto (Bbss), which is pathogenic to humans. Based on our findings, health-care providers should be aware that migratory songbirds widely disperse B. burgdorferi-infected I. scapularis in Canada’s North, and local residents do not have to visit an endemic area to contract Lyme disease.



Second posting today of infected ticks being in places they supposedly shouldn’t be.  I think we need to truly accept the fact Lyme/MSIDS is everywhere.  Make sure you spread the word to medical practitioners, your family and friends – and frankly anyone who will listen.  Infected ticks found in unlikely places including beaches.

Increasing Bbss in Tennessee Ticks

Increasing Prevalence of Borrelia burgdorferi sensu stricto-Infected Blacklegged Ticks in Tennessee Valley, Tennessee, USA.

Hickling GJ, et al. Emerg Infect Dis. 2018.


In 2017, we surveyed forests in the upper Tennessee Valley, Tennessee, USA. We found Ixodes scapularis ticks established in 23 of 26 counties, 4 of which had Borrelia burgdorferi sensu stricto-infected ticks. Public health officials should be vigilant for increasing Lyme disease incidence in this region.



Another study showing infected ticks in places most don’t suspect and the importance of spreading the word.  I pray long gone are the days when a doc stares at a CDC map and announces it can’t be Lyme because it doesn’t exist in their state.  Infected ticks are virtually everywhere. 


Co-Infection Patterns in Wisconsin Black Legged Ticks Show Associations Between Viral, Eukaryotic & Bacterial Microorganisms

Co-Infection Patterns in Individual Ixodes scapularis Ticks Reveal Associations between Viral, Eukaryotic and Bacterial Microorganisms.

Cross ST, et al. Viruses. 2018.


Ixodes scapularis ticks harbor a variety of microorganisms, including eukaryotes, bacteria and viruses. Some of these can be transmitted to and cause disease in humans and other vertebrates. Others are not pathogenic, but may impact the ability of the tick to harbor and transmit pathogens. A growing number of studies have examined the influence of bacteria on tick vector competence but the influence of the tick virome remains less clear, despite a surge in the discovery of tick-associated viruses.

In this study, we performed shotgun RNA sequencing on 112 individual adult I. scapularis collected in Wisconsin, USA. We characterized the abundance, prevalence and co-infection rates of viruses, bacteria and eukaryotic microorganisms.

We identified pairs of tick-infecting microorganisms whose observed co-infection rates were higher or lower than would be expected, or whose RNA levels were positively correlated in co-infected ticks. Many of these co-occurrence and correlation relationships involved two bunyaviruses, South Bay virus and blacklegged tick phlebovirus-1. These viruses were also the most prevalent microorganisms in the ticks we sampled, and had the highest average RNA levels.

Evidence of associations between microbes included a positive correlation between RNA levels of South Bay virus and Borrelia burgdorferi, the Lyme disease agent. These findings contribute to the rationale for experimental studies on the impact of viruses on tick biology and vector competence.


**Eukaryotes are protozoans or parasites which includes worms (nematodes/helminths)**

Mainstream medicine has yet to take into account the synergistic effect of all of the pathogens found within a tick upon human suffering.  So far they continue to believe this is a one pathogen/one disease/one drug paradigm, hence the mono-therapy of doxycycline as their answer to this 21st century plague.

Until this changes, we are doomed.

NY Grants Approval of IGeneX’s Lyme ImmunoBlot Tests’s-Newly

New York State Grants Approval of IGeneX’s Newly Developed Lyme ImmunoBlot Tests

Lyme ImmunoBlots (IgM and IgG) represents quantum leap in test performance over the traditional B. burgdorferi Western blots.

August 07, 2018 12:00 PM Eastern Daylight Time

PALO ALTO, Calif.–(BUSINESS WIRE)–The Division of Laboratories of the Department of Health of the State of New York has approved IGeneX’s newly developed Lyme ImmunoBlots (IgM and IgG), making it immediately available to New York practitioners.

Now, instead of sourcing test antigens from only one or two species of sonicated Borrelia, the ImmunoBlot is comprised of specific recombinant antigens from several species of Borrelia burgdorferi. The ImmunoBlot therefore detects the following US and European species of Lyme Borrelia: B. burgdorferi B31, B. burgdorferi 297, B. mayonii, B. spielmanii, B. californiensis, B. valaisiana, B. afzelii and B. garinii and makes the P31 epitope confirmation test unnecessary.

To test for all the above Borrelia burgdorferi species by Western blots, eight individual IgM and eight individual IgG tests are required. Performing 16 Western blots on each patient sample is expensive and impractical as opposed to just two tests with the Lyme ImmunoBlots.

“The Lyme ImmunoBlot is intentionally more inclusive for Borrelia burgdorferi sensu lato than the currently available Western blots because we now know that other species such as B. mayonii, B. californiensis and B. spielmanii all cause disease in the US,” said Dr. Jyotsna Shah, CEO of IGeneX. “With the increase of international travel in the last 10 years, people can get infected at home, other parts of the US or Europe depending on their lifestyle. Thus, it is important to have available a test that can detect the infection irrespective of where it was acquired.”

More Comprehensive Detection

The Lyme ImmunoBlot IgM detects the five following recombinant protein groups: P93, P41, P39, P31, and P23. Furthermore, the Lyme ImmunoBlot IgG detects these twelve recombinant protein groups: P93, P66, P58, P45, P41, P39, P34, P31, P30, P28, P23, and P18.

High Accuracy Across the Disease Spectrum

The accuracy of the Lyme ImmunoBlot has been established by exhaustive testing. The sensitivity with well-characterized samples has been shown to be greater than 93% whereas the two- tier testing recommended by CDC has a sensitivity of about 57.6% (Waddell LA et al. PLoS ONE. 2016;11(12):e0168613. doi:10.1371/journal.pone.0168613). Additionally, the ImmunoBlots detect the full spectrum of disease: early, active and late-stage disease. This high degree of sensitivity does not come at the cost of specificity. The specificity of the Lyme immunoblot is equivalent to CDC 2-tier testing (ELISA or IFA followed by Western blots).

New York State Department of Health Approval

The Clinical Laboratory Evaluation Program, Wadsworth Center, New York State Department of Health has approved the IGeneX Lyme ImmunoBlot (, making it available to all qualified New York practitioners and their patients. IGeneX works swiftly to ensure that this remarkable test can be utilized immediately.

The Wadsworth Center, a division of New York State Department of Health, is a science-based community committed to protecting and improving the health of New Yorkers through laboratory analysis, investigations, and research, as well as laboratory certification and educational programs. The Center serves a vital role in the New York State Department of Health’s efforts to protect and promote the health of New York’s citizens.

About IGeneX

For over 25 years, IGeneX has been at the forefront of research and development of diagnostic testing for Lyme disease, Relapsing Fever, and other tick-borne diseases. IGeneX arms its talented scientists with the most cutting-edge technology available to enable them in finding new solutions that challenge the status quo of testing for Lyme and associated tick-borne diseases. This team of experienced, hands-on experts develops these tests in-house using a wider spectrum of relevant proteins and strains that look for and detect more. 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: www.



Lyme Nanotrap Test Granted Breakthrough Device Designation by FDA

Ceres Nanosciences’ Point-of-Care Nanotrap® Lyme Antigen Test System Granted Breakthrough Device Designation by U.S. Food and Drug Administration

Press Release: Ceres Nanosciences, Inc., Manassas, Virginia

July 12, 2018

Ceres Nanosciences (Ceres) announced today that is has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its new point-of-care Nanotrap® Lyme Antigen Test System.

Under the Breakthrough Device program, formerly the Expedited Access Pathways program, the FDA works with a test developer to reduce the time and cost from development to approval.

The Ceres’ Nanotrap® Lyme Antigen Test System is a powerful diagnostic test that is intended to be available in point-of-care settings, like a physician’s office or a walk-in clinic. Requiring only a patient’s urine sample, it will deliver results to the physician and patient at the earliest stages of infection, when treatment is most successful.

“We’re truly grateful to receive the FDA’s Breakthrough Device designation for the Nanotrap® Lyme Antigen Test System,” said Ross Dunlap, Chief Executive Officer of Ceres Nanosciences. “This will accelerate our delivery to patients of a much needed test for Lyme disease, a devastating and increasingly common infectious disease that can cause irreparable harm if not detected and treated early on.”

To achieve Breakthrough Device designation, a device must demonstrate compelling potential to provide more effective diagnosis for life-threatening or irreversibly debilitating diseases. In addition, the device must meet at least one of the following criteria: represent breakthrough technologies; no approved or cleared alternatives exist; offer clinically meaningful advantages over existing approved or cleared alternatives; or the availability of which is in the best interest of patients.

About Ceres Nanosciences, Inc.

Ceres Nanosciences is a privately held company, located in Prince William County, Virginia, focused on the development of research and diagnostic products using its unique and proprietary Nanotrap® particle technology. The Nanotrap® particle technology provides powerful biomarker capture and biofluid sample processing capabilities for a wide array of diagnostic applications and sample handling needs. The Nanotrap® particle technology was invented at George Mason University and developed under funding from the National Institutes of Health (NIH). With support from the NIH, the Defense Advanced Research Projects Agency (DARPA), the Bill and Melinda Gates Foundation, and the Commonwealth of Virginia, Ceres is focused on incorporating this technology into a range of innovative diagnostic products. Learn more at

Press Contact:

Ross M. Dunlap
Ceres Nanosciences, Inc
1.800.615.0418 ext. 202



Direct quote from Ceres:

The Nanotrap® Lyme Antigen (LA) Test is a novel, high sensitivity, DIRECT test for Lyme that will provide valuable information to assist a physician in diagnosing and treating Lyme disease at most stages of infection.

So this is not the end all.  People are going to slip through cracks here as well.  Please keep this in mind.

While using urine samples to directly detect Bb, (other tests use indirect testing by testing for antibodies), it relies on Bb being in the urine.  We all know Bb is a stealth organism that goes where it pleases – Often where it can’t be found.

For more:

Samuel Shor, MD, FACP: We’re involved in the study of 2 tests that are very promising. One is called the Nanotrap, which looks at a highly specific protein called OspA that is found across multiple strains of Borrelia. And what this technology does is super concentrate, in a urine sample, the presence of this protein and then further tests it, and, it’s 1000-fold more sensitive than the standard Western Blot. In our 2015 paper that was published in the Journal of Translational Medicine, in the preliminary erythema-migrans patients—who are very often negative in the ELISA test because they haven’t had the time to respond immunologically—24 out of 24 were positive with the Nanotrap test.

So it looks better but it’s not perfect…..


Crisis of Tick-spread Disease Crushes Ontario Teen

Crisis of tick-spread disease crushes London teen

Brandan Barnett, 16, has been battling lyme disease for four years after it wasn’t properly diagnosed in London, Ont. Mike Hensen/The London Free Press/Postmedia Network

A day after Canadians celebrate a civic holiday, a London couple will go on their only trip of the summer, driving more than 800 kilometres to Maryland to seek care for a 15-year-old son — care they can’t find in their own country.

Brandan Barnett was once a 12-year-old boy who excelled in school, played AAA hockey for the London Knights and whose can-do attitude inspired his firefighting father Dan and his mom Lisa, an education assistant who helps special needs kids.

Four years later, his body has been ravaged by disease, his parents’ faith in our health care system has been obliterated, and they have placed all their hope on an American doctor who specializes in tick-borne illness like Lyme Disease.

“Brandan had his life stolen from him in an instant, and at every turn, we had absolutely no help from our current medical system at all,” Lisa Barnett told The Free Press. “We were passed from one specialist to another, none knowing what to do (and) had to watch our child become suddenly bedridden.”

The Barnett’s experience is all too typical in a country in which Lyme disease has grown to epic proportions, a crisis that neither doctors nor public health officials have adequately addressed, say a registered nurse and lawyer who have made headway pressing their cause to politicians in Ottawa.

“We have heard similar stories time and time again all across Canada,” said Sue Faber, a registered nurse who battled Lyme for 14 years before co-founding an advocacy group called LymeHope that’s made its presence felt in Ottawa. “It’s just a huge crisis.”

Among with lawyer Jennifer Kravis, the group has swum upstream against the current of conventional practice and belief in Canada, whose doctors and public health officials have resisted the notion that Lyme disease is spreading quickly, can create chronic and debilitating symptoms that last for years, and can be passed through childbirth from mothers to children.

In the last year alone, Faber and Kravis have met with Federal Health Minister Jane Philpott, hosted an Ottawa event that drew more than 40 MPs, testified before a senate committee on health, enlisted the support of one of the Canada’s most influential advocacy groups — the Registered Nurses Association of Ontario —  and persuaded The Public Health Agency of Canada to list on its website aggressive treatment guidelines created last year by the International Lyme and Associated Diseases Society.

Their efforts have also resonated with everyday Canadians, of whom more than 65,000 have signed a petition pushing for change.

But even doctors who have adopted the changes are reluctant to speak out for fear of being ostracized by their peers. “This is a very controversial disease. (Some doctors) are hesitant to get their names out there,” Faber said.

That resistance to change has crushed Brandan Barnett, who for more than four years has been so sick he has been too weak to even attend school — at 5 feet 11, he weighs only 110 lbs.

“He’s gone from a 24/7 never-stop kid to a kid who couldn’t get out of bed,” Lisa Barnett said. “It’s the fight of his life.”

The descent was rapid. After a camping trip to Pinery Provincial Park, a hot spot for Lyme disease, Barnett was playing hockey at Nichols Arena in February, 2014 when he was suddenly overwhelmed with flu-like symptoms. Doctors were stumped, and when a rash developed on his back, a dermatologist prescribed steroids, which only made him worse.

What followed was a parade of specialists: a pediatrician, gastroenterologist, an infectious disease expert, and even a psychiatrist after one doctor suggested the problems might all be in his head.

The notion that a tick might be the source of his ills came from a family friend whose child had Lyme disease.

That led to the family’s first trip to Maryland to the first specialist who seemed to have any idea about what was plaguing Brandan — Dr. Bobak Mozayeni specialized in tick-borne illness.

While tests didn’t show Lyme disease, they did confirm another tick-spread illness, Bartonella. Mozayeni prescribed a lengthy course of antibiotics, and for the first nine months of 2017, Brandan improved.

But in November, the bottom dropped out — Brandan lost 20 pounds in four weeks.

While his parents hope their coming trip to Maryland will help Brandan turn things around, they are devastated their son lost three years to what they believe were missteps by Canadian doctors.

“Brandan might have been able to avoid years of unbelievable suffering (in) pain as his body was attacked by this illness. It shouldn’t be this way. When your child gets really sick, there should be support in Canada,” Lisa Barnett said.

“He had hopes, dreams and a future (and ) I need to do everything I can to mend and heal what this illness has destroyed and taken from him already. He is strong and resilient, and if there is a way to get his health back we will persevere and achieve it. Thank God for his positive attitude.”

Public health agencies in Canada already do one thing well, say Faber and Kravis — the agencies publicize how to lessen the risk of being bitten by a tick, and what to do if they find a tick

But while prevention is a worthy goal, the two advocates say Canadian doctors must learn how to properly diagnose and treat Lyme and other tick-borne illness. Many current practices are concerning, they said:

  • Doctors test for one strain of Lyme disease when evidence suggests there may be as many as 300.
  • Doctors won’t use a test well-established in the United States and Europe, a Western Blot test, unless patients first test positive using a method that is known to miss many cases, an Elisa test.
  • Public health rely on 12-year-old American standards that are no longer used by leading American tick-borne disease specialists
  • Doctors don’t search for other illness such as Bartonella that are carried by ticks whose population is growing as the climate warms.

The lack of vigilance has created a chasm between the numbers of confirmed cases of Lyme disease and the numbers that LymeHope uses based on surveys of Canadians.

According to public health officials, fewer than 1,000 people were diagnosed last year with Lyme disease. But a survey found that one in 10 Canadians said either they had the disease or knew someone who did.

Despite that disagreement, local public health officials say the number of ticks in the London region is on the rise and the map of affected areas growing across Ontario.

This year and last year, those concerned about tick bites have sent two to three times as many ticks to be tested at the Middlesex-London Health Unit as in previous years, said Jeremy Hogeveen, the health unit’s vector borne disease co-ordinator.

“It’s growing. Climate change is altering the landscape,” he said. “The map of affected areas is growing every year.”

Only one lab in Canada tests ticks, the turn-around time for results is six months, so if someone has been in an area known to have black-legged deer ticks, the type that can carry Lyme disease, and shows symptoms of the disease, the health unit recommends seeing a doctor who can start antibiotics right away, Hogeveen said.

At the same health unit, the Associate Medical Officer of Health, Dr. Barry Pakes, is skeptical of some American practices that specialize in Lyme testing because he believes the tests are prone to show a positive match even when that’s not the case. That someone in London was diagnosed with Bartonella surprises him, as that is a disease that is more typically found in much tropical climates; Pakes said he saw cases when he worked in South America.



To the skeptic – Lyme and the various coinfections that often come with it are EVERYWHERE….

It is a huge mistake to limit the location and/or severity of this complex illness.

For more:  “People should be aware of ticks and tick-borne disease, even when they may think there’s not a recorded incidence of a tick in a county,” Nieto said. “These things, they’re not obeying borders. They’re going by biology. If they get moved there by a deer or bird or people or pets, they’re going to establish themselves and start growing.”

This tick border thing is a man-made constructed paradigm that has never been accurate, but it’s fit the CDC/NIH/IDSA narrative. (go to page 6 and read about Speilman’s maps which are faulty but have ruled like the Iron Curtain, and have been used to keep folks from being diagnosed and treated)

The climate-change issue is another man-made paradigm regarding ticks who will be the last species on the planet besides the IRS:

“Dr. Mozayeni talks about Bartonella as one of the major co-infections of Lyme disease. It’s more prevalent than Lyme, as there are many more ways to contract the disease (eg. flees, cats, arachnids, etc).  Many claim ticks also transmit it.”