DECLARATION OF ANDREW SAXON, M.D. knowledge, and if called to testify, I could competently do so.

Transcription

1 0 WILSHIRE BOULEVARD, TH FLOOR LOS ANGELES, CALIFORNIA 00-0 TELEPHONE --00 FAX --0 DECLARATION OF ANDREW SAXON, M.D. I, Andrew Saxon, M.D., declare as follows:. I am over years of age. I know the following facts to be true of my own knowledge, and if called to testify, I could competently do so.. I am a licensed physician in the State of California, specializing in the practice of Clinical Immunology and Allergy. I am currently a Professor of Medicine at the UCLA School of Medicine, Los Angeles, California. I served as the Chief of the Division of Clinical Immunology and Allergy at UCLA for nearly 0 years, and I founded the UCLA Asthma, Allergy and Immunologic Disease Center.. I am Board Certified by the American Board of Medical Specialties in Internal Medicine, Allergy and Clinical Immunology and Diagnostic Laboratory Immunology, the latter Board having particular relevance to the matter at hand. A copy of my CV is attached as Exhibit A.. I am a co-author of the American College of Occupational & Environment Medicine (ACOEM) Position Statement entitled: Adverse Human Health Affects Associated with Molds in the Indoor Environment that appeared in 0. A true and correct copy of this article is attached as Exhibit "B". The ACOEM represents more than,000 physicians and other health care professionals specializing in the field of occupational and environmental medicine. The ACOEM is the nation's largest medical society dedicated to promoting the health of workers through preventive medicine, clinical care, research and education.. I am also a co-author of the American Academy of Allergy Asthma and Immunology s (AAAAI) official Position statement entitled The Health Effects of Molds which appeared in February 0. The AAAAI, with over 000 members, is the nation s largest medical subspecialty society specifically dealing with the allergic and immune aspects of mold exposures. A true and correct copy of this position statement is attached as Exhibit "C".. The bases of this opinions set forth in this Declaration also include my LEGAL:0-00/. --

2 0 WILSHIRE BOULEVARD, TH FLOOR LOS ANGELES, CALIFORNIA 00-0 TELEPHONE --00 FAX --0 education, clinical and basic science training, experience in medicine in general and specifically related to immunology including immunotoxicology, my review and analysis of both basic and clinical studies in humans in general and specifically related to mold exposure, and my knowledge of the forms of disease that occur in humans related to mold and mold exposure. These include basic studies performed in the test tube and in animals, my own research in wide range of aspects of human and animal immune reactivity, my extensive reading in the areas of clinical immunology and allergy, and related areas, and my clinical experience including the diagnosis and management of patients with immunologically related disorders (allergic, immunodeficient/immunotoxic, autoimmune, and malignant). I have also read the publicly available published information about the various and varying assays that RealTime Laboratories, Inc. employs to measure and report on levels of "mycotoxins" in human biological specimens including the patent application for these measurements. Additionally, I have read the deposition of Dr. Dennis Hooper in a number of matters that relate to RealTime Laboratories, Inc.'s use of the various assays for rmycotoxins in human specimens.. Some of the only information available about the performance of RealTime Laboratories, Inc.'s Mycotoxin Mold Panel test is contained in one article published by Dr. Dennis Hooper: Hooper DG, Bolton VE, Guilford FT, Straus DC. Mycotoxin detection in human samples from patients exposed to environmental molds, Int J Mol Sci. 0 Apr ;():-. PubMed PMID: ; PubMed Central PMCID: PMC0. This article is published in the International Journal of Molecular Science, an "open access journal," where the author pays for the publication of the article. The level of peer review in such journals is minimal. The information in that manuscript is not consistent with the company's patent application as to the methodologies employed, nor does either of the sources actually report on the full and exact methodologies employed on the patients in the matter.. It is my opinion that RealTime Laboratories, Inc.'s Mycotoxin Panel tests lack the proper standard validation criteria that any new clinical assay must meet to be LEGAL:0-00/. --

3 0 WILSHIRE BOULEVARD, TH FLOOR LOS ANGELES, CALIFORNIA 00-0 TELEPHONE --00 FAX --0 considered by the relevant scientific community. Specifically, RealTime Laboratories, Inc.'s Mycotoxin Panel tests have not been shown to accurately determine that it is measuring what it says it is. Indeed, the fact that RealTime Laboratories routinely reported values of mycotoxins below the limit of detection of their own assays is highly problematic scientifically.. RealTime Laboratories, Inc. has not provided or published the data for the standard validation criteria that any new clinical assay must meet to be considered by the relevant scientific community and without this necessary validation. This includes the actual data used to define the sensitivity and specificity of the various mycotoxin testing employed, analysis of cross-reactivity and potential confounding substances in the assays, and comparison of the assay results with accepted gold standard assays for mycotoxin measurement.. The testing for various mycotoxins as performed by RealTime Laboratories, Inc. on human materials is not consistent with good laboratory practices. A. "Sound laboratory practice requires full characterization of an assay before its use for patient testing, irrespective of federally-designated test complexity and without regard to when it was first introduced by a given laboratory. The laboratory should have data on each test's analytic sensitivity, precision, and interferences as applicable. Such data may originate from manufacturers' information, published reports, an/or the laboratories own studies. B. Where current technology permits, accuracy is established by comparing results to a definitive or reference method, or may be verified b comparing results to an established comparative method. Use of reference materials or other materials with known concentrations or activities is suggested in establishing or verifying accuracy. Precision is established by repeat measurement of samples at varying concentrations or activities within-run and between-run over a period of time. C. The laboratory must verify or establish method performance specifications for analytic interferences. Interfering substances pose a significant problem to the clinical laboratory and healthcare providers who may be misled by laboratory results that do not represent the clinical conditions of patients. The laboratory must be aware of common interferences by performing studies or having available studies performed elsewhere (such as by the LEGAL:0-00/. --

4 0 WILSHIRE BOULEVARD, TH FLOOR LOS ANGELES, CALIFORNIA 00-0 TELEPHONE --00 FAX --0 instrument reagent manufacturer)." College of American Pathologists, Commission on Laboratory Accreditation (0). The non-existence of essential validating tools in the laboratory procedures for mycotoxin testng from RealTime Laboratories, Inc. renders any diagnostic meaning impossible. "Sensitivity," "specificity," "positive predictive value," and "negative predictive value" are the validating tools that physicians use to assess the utility and interpretation of laboratory tests. These four values serve as reference points to permit physicians to understand the context and relative accuracy of the laboratory test values. When the sensitivity, specificity, positive predictive and negative predictive values of a diagnostic test have not been determined, a physician cannot ascribe any diagnostic meaning to the laboratory results and cannot support or exclude a clinical diagnosis using such testing. Sensitivity is the ability of the test to pick up all of the diseased individuals (i.e. false negatives). Specificity is the ability of the test not to mistakenly detect normal individuals as diseased individuals (i.e. false positives). These are critical pieces of information in developing any diagnostic so that one can then generate what is known as the negative and positive predictive value.. RealTime Laboratories, Inc.'s Mycotoxin Panel tests, even if performed correctly, are not performed with definitive methods with which to detect and measure the level of specific mycotoxins in human tissue. The gold standard methodology to definitively detect specific mycotoxins in human material is the use of a validated and generally accepted methodology such as mass spectroscopy or high pressure liquid chromatography.. It is my opinion that RealTime Laboratories, Inc. Mycotoxin Panel lacks the necessary reference ranges developed from appropriate validated normal controls and proven diseased individuals to allow the assay, even if accurate, to have any biological meaning All humans have ongoing exposures to mycotoxins, primarily through diet. Indeed, there are USDA regulations as to the level of mycotoxins in food such as peanut butter. Thus it is necessary to have a carefully established reference range to know the LEGAL:0-00/. --

5 0 WILSHIRE BOULEVARD, TH FLOOR LOS ANGELES, CALIFORNIA 00-0 TELEPHONE --00 FAX --0 levels seen in the general population. Furthermore, just because a level is higher than that in the general exposed population, that result does not mean that such level is going to be associated with adverse health effects. A separate range of values associated with disease end points also needs to be established. RealTime has failed to establish such reference ranges. Thus, RealTime Laboratory, Inc.'s reporting mycotoxin value without appropriate reference range that relates to a level at which an adverse health effect is seen is meaningless as all humans will have some level of various common mycotoxin present in their body and bodily fluids. The detection of different mycotoxins by RealTime Laboratories, Inc., even if they were accurate, simply reflects the sensitivity of the assays and by itself is NOT an indication of a level of mycotoxin associated with potential adverse health effect.. The reporting of mycotoxins in the human material including urine using RealTime laboratories tests, even if the testing was accurate, reflects dietary intake, not inhalation from environmental exposures. It is widely understood that the overwhelming source of mycotoxin exposure is dietary, not inhalation so that any measurement of mycotoxins reflects diet and not other environmental exposures. Thus, RealTime Laboratories, Inc.'s test is not generally accepted as valid in reflecting potential inhalational exposures for any such exposures, should they occur, would be overwhelmed by the dietary intake of mycotoxins.. It is my opinion that CLIA certification of RealTime Laboratories, Inc. does not validate RealTime laboratories mycotoxin testing as CLIA does not assess the validation of such testing.. For all these reasons, it is my opinion that the testing performed by RealTime Laboratories, Inc. (Dr. Dennis Hooper Director) as to the levels of various mycotoxins in human specimens, including human urine, cannot be relied upon to accurately detect mycotoxins in human materials, and are not generally accepted in the scientific community. I declare under penalty of perjury under the laws of the State of California that the LEGAL:0-00/. --

6 foregoing is true and correct. Executed November,, at Santa Monica, California. Andrew Saxon, MD WOOD, SMITH, HENNING & BERMAN LLP 0 WILSHIRE BOULEVARD, TH FLOOR LOS ANGELES, CALIFORNIA 00-0 TELEPHONE --00 FAX --0 LEGAL:0-00/. --