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Are All FDG PET-CT Reports the Same?

With the introduction of FDG PET imaging into the medical marketplace in the 2001-2002
timeframe, there was a scramble to find competent readers of the technology. Predictions of
significant numbers of PET studies to displace anatomic imaging (CT, MRI and US) were
predicted. Properly trained and confident readers of the technology became a valuable asset to
hospitals, imaging centers and oncology practices filled the positions to make readers available.
The entire industry was tasked with both extolling the technology and training physicians to
provide accurate appraisals of the metabolic status of disease.

However, almost two decades later, FDG PET-CT has only 5% of the oncology imaging market
in the United States. This translates into 30 million CT studies performed annually for the
purposes of Staging and Restaging malignancy as well as the assessment of Treatment
Intervention. FDG PET imaging for oncology is on the order of 1.5 million FDG PET studies
performed on an annual basis.

This is completely illogical when one considers the following:

(1) Biology and biochemistry precede anatomic expression of both untreated and treated
malignant disease
(2) The above is well documented in the peer reviewed literature and both the sensitivity and
specificity of FDG PET is significantly greater than that of anatomy-based imaging (CT).

It is assumed that all board-certified physicians in imaging practice, including the American
Board of Radiology, American Board of Nuclear Medicine, American Osteopathic Board of
Radiology have the professional credentials to read and interpret radiology and nuclear medicine
imaging examinations. A significant number of radiologists have subspecialty training including
competency in nuclear medicine. Nuclear medicine physicians are completely dedicated to the
practice of nuclear medicine.

When HCFA (now the CMS) made the decision to provide codes initially for pulmonary nodule
and lymphoma and eventually virtually all malignancies by 2003-2005, there was a scramble to
get qualified readers to interpret and decipher FDG PET studies. Due to the inherent nature of
the FDG PET scan and the inputs from an anatomy-based radiologist, the dedicated PET scanner
was replaced with PET-CT devices so the anatomy could be registered to the metabolic data set
and the anatomic correlate of the FDG finding was made available.

However, this did not completely rectify the specificity or the sensitivity of FDG PET study
issues with the findings on CT as the FDG PET study being more sensitive in most cases, left
reconciliation of the two technologies somewhat apart. Reliance on anatomy-based imaging (CT
and MRI) is unsatisfactory due to its known diminished sensitivity and specificity compared to
FDG PET and the flawed assumptions associated with anatomy’s response to treatment
intervention.

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To circumvent these issues, quantification of the FDG PET data set was introduced and is
commonly referred to as the Standard Uptake Value (SUV). This reflects the count statistics
localized to a particular region of interest on the FDG PET study that expresses the regional
glucose consumption of the known or suspected malignant condition.

Unfortunately, the application of the SUV metric whether corrected for the patient’s weight or
lean body mass (SUL) have NOT brought the capabilities of the FDG PET study into its proper
position as the preferred imaging modality for assessment of malignant disease in aspects of
medical practice, to include Staging, Restaging and Treatment Intervention.

Due to the fact that SUVs are not reliable across all patient populations then consideration needs
to be given to include all patients studies with FDG PET regardless of the vendor imaging
device, or whether the same patients are studied on different hardware or the same patients are
studied on the same camera, or at the same location under as nearly identical circumstances as
possible, the application of FDG PET imaging has been relegated to visual interpretation with
most clinicians not giving credence to the crucial quantification parameters. This has caused
major confusion in PET CT imaging and a near complete reliance on anatomic imaging.
(CT and MRI)

Therefore, Accurate Quantification is the key to unlocking the missing potential of this most
powerful technology. Without standardization of the quantifiable metric, FDG PET will remain a
minor contributor to the assessment of patients with malignancy, when in fact it should be the
MAINSTAY of imaging for oncology due to its capability to define the cellular status of cancer
cells and oncological disease.

The solution to the above problem with FDG quantification has not been resolved by mainstream
medicine, equipment vendors, academia or professional societies. All attempts at standardizing
the SUV calculation through the efforts of PERCIST or providing for the most consistent
acquisition parameters of the study itself (phantom introduction, calibration refinement, same
device-same dose-same institution acquisitions) have NOT fixed the problem. Therefore, all
FDG PET reports including those from prominent institutions do not include essential
quantification parameters.

If the quantification of FDG PET imaging is meaningless, then there is no reason to include them
in patient care since they can potentially mislead clinicians in the settings of Staging, Restaging
and Treatment Intervention appraisal. Additionally, the luminaries associated with the definition
of treatment of lymphomas have adopted a completely visual scoring system for the
interpretation of FDG PET studies, all but eliminating the SUV quantification.

As such, any board-certified radiologist or nuclear medicine physician can be considered as a

commodity as any properly trained physician in the imaging specialties should be able to read
FDG PET-CT with equal acumen. With the limitations placed upon the technology and the
imaging data delivered to the reader, this is the case today. Checking a box so to speak, is now
acceptable behavior.

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There will be differences in competency of readers, but not enough to make a perceived
difference or at least one that is positive enough to impact patient care and outcome. Since all
board-certified physicians in the imaging field are trained and through the completion of their
respective training programs and have passed the certification examinations, the administrative
wing of medicine for imaging can be assured that all physicians having the credentials to read
imaging examinations.

This means all reports should have similar content, offer the same product or report that contains
identical or at least relatively similar data and provides the clinician with the information
necessary for patient care and the perception of the referring physician that they are receiving
optimum information. Unfortunately, medical administrations, practicing physician imaging
professionals and referring clinical physicians do not expect the technology to perform at a
higher level than what is currently accepted.

Therefore, all participants including the CMS, third party payers as well as malpractice handlers
are perfectly comfortable with the limited application of FDG PET versus CT imaging in
addition to the limited information provided by the non-standardized FDG PET product. Thus
the 5% market share of FDG PET today does not reflect its markedly superior capabilities for
medicine, for the patient and for reduced cost for providers. Is there an alternative to the status
quo which at this point make a difference in the delivery of the FDG PET-CT interpretation?

The key to answering this question would the provision of standardization of the FDG
quantification metric (SUV). This development would change the entire paradigm not only of
the FDG PET study’s role in the evaluation of malignant disease, but also more importantly the
delivery of completely objective and precise information that directly reflects the biochemical
and metabolic status of known or suspected cancerous disease.

This HAS BEEN uniquely and SUCCESSFULLY accomplished with the introduction of
ACCUQUAN, an EU patented and US patent pending methodology-intellectual property that
solves the standardization problem once and for all.

For the past two decades there has been an ongoing quest to unlock the full potential of the FDG
PET examination. Since glucose resides at the top of the cellular food chain and provides the
energy necessary to run all cellular dynamics, it is and has been critical and essential to find a
resolution to this enigma. There is NO other way to accomplish this solution as attempts at
acquisition-based remedies based on machines or technical considerations as well as patient-
oriented determinations, have not been remotely successful and so the dilemma remains.

With the application of ACCUQUAN, the standardization and correction of the quantifiable
count statistics inherent to FDG PET scanning are readily available only through the specific
readings accomplished with the technology. There is a considerable difference in accuracy of
standardized and corrected FDG SUV calculations and those of uncorrected and non-
standardized quantifications. In addition, this is the only method capable of providing totally
objective assessment of treatment intervention and was COMPLETELY and TOTALLY
developed by the founder of ACCUQUAN.

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The technology is NOT available anywhere else in the United States or the world over. The
protection of the intellectual property precludes it use and availability from any vendor or third-
party platforms. The development of ACCUQUAN will be extremely valuable for patient care
and the medical imaging market. There is/was NO other way to achieve this breakthrough.

Discussions with the CMS have alluded to the provision of an individual and specific code for
the implementation of this much needed component for FDG PET imaging as no current code
exists for quantification in FDG PET. Introduction of new radiopharmaceuticals are not the
answer to intervening in oncologic disease through the insight of imaging because FDG PET
should, can and will perform this function without equal when the standardization of the SUV
metric is universally applied and accepted in all aspects of cancer medicine and patient
healthcare.

Dr. Richard Black March 11, 2019

Copyright ©2019 Richard R Black, D.O. All Rights Reserved. Proprietary and Confidential.