Today’s letter to the Tick-Borne Disease Working Group....
--------- Original Message ----------
From: CARL TUTTLE <runagain@comcast.net>
To: "tickbornedisease@hhs.gov" <tickbornedisease@hhs.gov>
Cc: (97 Undisclosed recipients)
Date: 11/13/2020 11:40 AM
Subject: Galaxy Diagnostics Launches the Most Sensitive Test Available for Direct Detection of Lyme Disease
To the Tick-Borne Disease working Group,
Please see the letter below addressed to the Chief Scientific Officer of Galaxy Diagnostics. The contents of the letter relate to the activity of the New Hampshire Lyme Study Commission under Section 141-C:6-a and a copy of this letter was sent to all members of the Commission.
Carl Tuttle
--------- Original Message ----------
From: CARL TUTTLE <runagain@comcast.net>
To: ebbreits@ncsu.edu
Cc: (5 Undisclosed recipients)
Date: 11/13/2020 10:33 AM
Subject: Galaxy Diagnostics Launches the Most Sensitive Test Available for Direct Detection of Lyme Disease
Galaxy Diagnostics Launches the Most Sensitive Test Available for Direct Detection of Lyme Disease ($295)
https://www.prnewswire.com/news-releases/galaxy-diagnostics-launches-the-most-sensitive-test-available-for-direct-detection-of-lyme-disease-301169364.html
“Galaxy validation data (unpublished) shows that the Nanotrap® Urine Test will often confirm active infection in patients with negative TTT (Two-Tiered Testing) results.”
Nov 13, 2020
GALAXY DIAGNOSTICS
6 Davis Drive, Suite 201
Research Triangle Park, NC 27709
Attn: Edward Breitschwerdt, DVM, Chief Scientific Officer
Dear Dr. Breitschwerdt,
Thank you for announcing the Nanotrap® Urine Test for Lyme disease. For nearly four decades now the only FDA approved test for Lyme disease is the indirect two-tiered antibody test. (Humans do not produce antibodies for 4-6 weeks after a tick bite) Direct detection methods to identify the causative agent responsible for the disease have been avoided, criticized, shelved and outright rejected by the US Centers for Disease Control.
Examples:
1. Culture test from Advanced Laboratory Services:
Assessment of New Culture Method for Detection of Borrelia Species from Serum Assessment of Lyme Disease Patients Barbara J. B. Johnson, Mark A. Pilgard and Theresa M. Russell https://www.ncbi.nlm.nih.gov/pubmed/23946519
Barbara Johnson of the CDC claims contamination is the major issue with this new culture method. Why didn’t the CDC work with Advanced Laboratory Services to correct any issues and perfect this laboratory testing method?
2. National Institute of Standards and Technology (NIST)
New Experimental Test Detects Signs of Lyme Disease Near Time of Infection February 11, 2016 https://www.nist.gov/news-events/news/2016/02/new-experimental-test-detects-signs-lyme-disease-near-time-infection
Response from a recent communication with Illarion Turko, Research Chemist: “This project did not receive further development and is on-hold for now.”
3. 16S rRNA sequence analysis As soon as Dr. Sin Lee published his findings of persistent infection from serum samples he received from the CDC, all communication stopped.
$57 million claim against the CDC on Lyme test: https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/20864023
Nested PCR and Sequencing for Lyme disease through Milford Molecular Diagnostics can detect early infection with as few as 25 bacteria per mL of blood.
Source: http://www.dnalymetest.com/faq.html
In contrast, the CDC announced the Development of a Novel Genus-specific Real-time PCR Assay for Detection and Differentiation of Bartonella Species and Genotypes
http://www.ncbi.nlm.nih.gov/pubmed/22378904
DNA testing is being used for Bartonella and now Zika:
CDC Lauds New DNA Test for Zika in Blood
http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/58622?xid=nl_mpt_DHE_2016-06-18&eun=g750897d0r
There is a double standard for Lyme disease in reference to DNA testing.
Per the testimony of Clinical Psychologist Dr. Richard Shulik reporting on patient experience with Lyme testing in New Hampshire: (Personal Dropbox storage area) https://www.dropbox.com/s/8gxit7rqeyo1tux/Dr%20Shulik%20Letter%20Jan%202010.pdf?dl=0
“Many of them (Lyme Patients) also found themselves in long-running disputes with disability insurance providers who accused them of malingering and who even refused to recognize their diagnosis of Lyme disease when it was confirmed. To say the least, these are nightmarish experiences which I would not wish upon anyone.”
___________________________
Dr. Breitschwerdt, there appears to be a concerted effort to deny a Lyme disease diagnosis when patients do not meet the CDC’s strict criteria for positive serologic results. Any other test no matter how accurate is intentionally overlooked to avoid financial responsibility for active disease.
Patient testimony all across America is describing a disease that is destroying lives, ending careers while leaving its victim in financial ruin. [1] Patients who end up disabled by Lyme are left to fend for themselves. Any test that identifies failed treatment (chronic Lyme) contradicts the existing false paradigm; chronic Lyme does not exist.
Question:
Does Galaxy Diagnostics intend to file for FDA approval of the Nanotrap® Urine Test?
Respectfully submitted,
Carl Tuttle
Lyme Endemic Hudson, NH
Cc: Galaxy CEO Amanda Elam
Ross Dunlap, CEO and a co-founder of Ceres Nanosciences.
Reference:
1. By way of introduction, I am the Change.org petition organizer calling for a congressional investigation into the mishandling of Lyme disease. For the past decade I have investigated the mishandling of Lyme disease after ending up bedridden on oxygen and near death in the fall of 2008.
The petition has generated over 1100 pages of heart wrenching comments from horribly disabled patients around the globe. Latest comment file:PDF (Please feel free to download from my Dropbox account)
https://www.dropbox.com/s/d40isfeff5h806o/petition_comments_Oct%2028%202020.pdf?dl=0
Tuttle directs pointed questions to TBD Working Group member Shapiro
https://www.lymedisease.org/carl-tuttle-tbdwg-comments/