New Diagnostic Test For Lyme Disease?

New Diagnostic Test For Lyme Disease?

One of the most devastating aspects of contracting Lyme disease today is the absence of a reliable test to diagnose Lyme and/or many of the co-infections that contribute to unnecessary suffering and mental anguish.

If you are bitten, the current protocol for doctors is to test the blood for antibodies using the ELISA test – which even some of the proponents of this system will admit to an 45%accuracy rate.  Then, IF you have a positive ELISA the protocol is to take a Western Blot which is even worse now that the standard has been changed. An abstract was performed using a group of 66 children who tested positive under the old standard and re-testing the same children with the new standard, only 20 children tested positive. That means 46 children would have been sent home without treatment – an accuracy rate of only 31%!

Well, a great stride towards positive diagnosis for Lyme disease may be just around the corner.

Business Wire  has recently announced promising developments regarding the diagnosis of  certain types of cancer that prove to be indicative of Lyme disease as well.

Multimmune GmbH and Boulder Diagnostics Inc. have jointly announced the development of an HSP70 lateral flow point of care test.

Multimmune has discovered that many tumor types display the heat shock protein 70 (Hsp70) on the cell surface. Multimmune is exploiting this signal for directed immune therapy to cure cancers.

The HSP70 lateral flow point of care test is being developed to test for elevated HSP70 levels in the blood of cancer patients and to evaluate the correlation of this occurrence with the presence of the tumor specific HSP70 cell surface marker. Boulder Diagnostics Inc. draws on its leading competence in lateral flow assay development to develop the HSP70 point of care test.

“The HSP70 point of care test will help us more rapidly to advance the important concept of tumor therapy against HSP70 expressing cancers”, comments Claus Botzler, Managing Director of Multimmune GmbH.

“We are excited to apply our extensive lateral flow assay development expertise to this novel and important diagnostic opportunity”, states Dede Willis, Chief Operating Officer of Boulder Diagnostics Inc.

Multimmune GmbH develops tumor therapies based on exploitation of tumor-specific cell surface markers.

They have advanced an ex vivo immune recruitment therapy against HSP70 displaying colon and lung cancers through clinical phase I, and have demonstrated pre-clinical proof of concept of an antibody therapeutic against HSP70 displaying tumors.

Their partner Boulder Diagnostics, is dedicated to the development of point of care lateral flow diagnostic assays, and is currently developing products to detect elevated homocysteine levels and for the diagnosis of Lyme disease.

There is fierce competition from research labs for grant money which will eventually turn the entire medical community “on its ears”, when the advancement of scientific understanding severs the wall of medical compliance with regards to diagnosing and treating chronic Lyme disease.

(This part originally posted on January 14, 2010 – the rest is a follow-up)

Shortly after the above press release, a scientific medical paper about advanced testing was printed in the April 2010 edition of the “American Journal of Clinical Pathology.”

“If people are infected with the Lyme spirochetes, and not treated quickly, thousands may suffer for many years from the debilitating effects of the disease. “But if, after infection, the bacteria are identified without delay, the patient can be effectively treated and totally cured,” said Connecticut physician Sin Hang Lee, MD.

There have been other PCR tests for early Lyme disease. But this is the first effective one using nested PCR for detection and DNA sequencing to validate the molecular diagnosis, in clinical laboratory medicine. DNA sequencing is accepted as the gold standard for molecular identification, said Dr. Lee.

Dr. Lee, a pathologist, and his colleagues at Milford Hospital (Milford, CT) have developed the first highly sensitive and specific DNA test for the diagnosis of early Lyme disease before the traditional serology lab tests become positive. If the clinician awaits the rising Lyme disease antibody titers (which is normally the case) to make a diagnosis, the diagnosis of Lyme disease may be delayed, or even missed. The literature reports that up to 75% of the patients with acute-phase Lyme disease are negative for the characteristic antibodies, but in fact the percentage is higher, he said.

In technical terms, the new LoTemp® nested polymerase chain reaction (PCR) method detects a genomic DNA of the Lyme disease-causing spirochete in the blood, which is further validated by DNA sequencing. It is the marriage of both that minimizes false-negatives to the lowest possible and eliminates false-positives known to be associated with other Lyme disease DNA tests. Symptomatic patients visiting the emergency department or the walk-in center have the best chance for an early diagnosis by this new test.

The waiting for a scheduled visit to the doctor’s office usually misses the window of opportunity in DNA detection at the time when the bacteria are circulating in the blood of the patient in early Lyme disease, but only briefly, said Dr. Lee.

Dr. Lee is also now collecting data and writing a second report for publication with Jay Walshon, MD, chairman of Emergency Medicine at Milford Hospital and Jessie Williams, MD, of the Milford Hospital Walk-in Urgent Care Center, to summarize their experience. Milford is a suburban city outside of New Haven, in southern Connecticut. The region has about 600,000 people and is located less than an hour from Old Lyme, from which Lyme disease was named.

Lyme disease is endemic in the suburban towns in and around the Milford area, which although located by Long Island Sound, is also in many areas heavily wooded. Dr. Lee’s group reported that 25-50% of the engorged deer ticks removed from the human skin bites in this area were found to be infected by the Lyme disease causing spirochetes, Borrelia burgdorferi.

Although the new method based on the nested PCR technology is highly sensitive in detecting Lyme spirochete DNA, a negative result still does not rule out Lyme disease because spirochetemia is transient and its time points in Lyme borreliosis vary from patient to patient, said Dr. Lee.

Sadly, this good news quickly tanked when the drug company politics jumped in and as “Orac” (a pseudonymous surgeon/scientist who blogs about these outrageous acts of foolishness)  says in his ScienceBlog.com, “It Couldn’t Have Happened to a Nicer Guy”

ORAC tells how Merck, the owner and producer of Gardasil (the anti-cancer vaccine that was so helpful in all of this research) was outraged that Dr. Lee found HPV DNA in Gardisil which was not even close to the point.  Instead of rejoicing and rewarding the outstanding pathologist who dared to find a much more sensitive method of PCR that managed to detect HPV DNA that couldn’t be detected before, and all the huge doors that could be opened to helping people with such highly specialized medicine, Merck ran Dr. Lee out of town!

The less charitable (and more likely to be accurate) interpretation is that it was all a false positive or due to a problem with technique. PCR is, after all, very sensitive, and the sort of nested PCR that was apparently used to produce SaneVax’s astounding revelation is even more sensitive than standard PCR

In any case Dr. Sin Hang Lee has been having problems. Lots of problems. So many problems that SaneVax has decided to try to help him out. Last week, SaneVax issued a press release complaining that Dr. Lee is being “persecuted” for his association with the organization:

Because of studies submitted to the FDA prior to approval of HPV vaccines indicating there was a substantial increase in pre-cancerous lesions for those who had already been exposed to vaccine-relevant genotypes of HPV before they were injected with Gardasil® or Cervarix®, Dr. Lee agreed to offer his cutting edge technology HPV genotyping test to medical consumers throughout the United States to protect those who were considering HPV vaccination so they could avoid that potential risk. The decision was announced to the public via a BusinessWire Press Release on 20 September 2010.In the fall of 2010, without Dr. Lee’s knowledge or having an opportunity to defend himself, the newly appointed Chairperson of the Pathology Department at Milford Hospital informed the hospital’s credentialing committee that she was not recommending for approval or supporting Dr. Lee’s application for renewal of his medical staff privileges. For those who do not know, medical staff privileges at a hospital are a major asset to a medical doctor and they establish the relationship that permits among other things, the doctor to practice at a particular hospital. When medical staff privileges at a hospital are revoked or not renewed, the doctor no longer has permission to practice at the hospital or use its facilities. The non-renewal of the medical staff privileges, may also adversely affect the doctor’s license to practice medicine. In Dr. Lee’s case, the non-renewal of his medical staff privileges at Milford Hospital is under appeal.

Although Dr. Lee still maintains his medical staff privileges during the appeal, his position as director of the laboratory was summarily terminated along with his employment relationship at Milford Hospital on December 13, 2010 and he has been prevented from using the hospital’s laboratory to continue his testing and research there ever since that time. A lawsuit addressing the wrongful termination claim has been brought against the Milford Hospital.

Well, isn’t that interesting? Funny how SaneVax didn’t mention this when it issued its previous press release announcing that it had found HPV DNA in Gardasil. That was only a month or so ago, and apparently Dr. Lee had been canned as the director of the diagnostic laboratory at Milford Hospital over 9 months prior. Interesting. At least I think it is. Certainly, one wonders why SaneVax has issued this press release now, rather than back in December, when Dr. Lee lost his leadership position. In any case, it’s a rough world out there; if a new chair comes in, not so infrequently, a major housecleaning will occur shortly thereafter, as the new chair tries to put a mark on the place and take the department in a different direction. Thank you ORAC for giving us the real skinny on what happened to our genius pathologist in Milford.

Today, Dr. Lee is still studying the DNA of Borrelia burgdorferi at Milford Hospital.  And he is still publishing in the American Society for Clinical Pathology.  His most recent paper can be read here, “Increased Sensitivity and Specificity of Borrelia burgdorferi 16S Ribosomal DNA Detection”  if

More Reading: Dr. Sin Hang Lee: Why Ethics Don’t Pay; Office of Medical and Scientific Justice

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