Chemistry: analytical and immunological testing – Lipids – triglycerides – cholesterol – or lipoproteins
Reexamination Certificate
2002-11-14
2003-11-25
Warden, Jill (Department: 1743)
Chemistry: analytical and immunological testing
Lipids, triglycerides, cholesterol, or lipoproteins
C436S013000, C436S016000, C436S173000
Reexamination Certificate
active
06653140
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to reporting and analyzing information related to patient-specific measured lipoprotein results.
BACKGROUND OF THE INVENTION
Recently, a significant advance in measurement techniques used to analyze blood plasma lipoprotein samples was achieved. Lipoproteins are the spherical particles that transport cholesterol, trigylcerides, and other lipids in the bloodstream. The advanced measurement technique employs NMR spectroscopy to provide additional (higher order) increased patient-specific information over the types of information typically provided under routine conventional analysis methods. See U.S. Pat. No. 4,933,844 to Otvos, entitled “
Measurement of Blood Lipoprotein Constituents by Analysis of Data Acquired From an NMR Spectrometer”
and U.S. Pat. No. 5,343,389 to Otvos, entitled “
Method and Apparatus for Measuring Classes and Subclasses of Lipoproteins.”
The contents of these documents are hereby incorporated by reference as if recited in full herein. Unlike conventional “routine” type laboratory lipoprotein blood tests, the lipoprotein analysis provided by the NMR spectral analysis now more easily provides lipoprotein subclass information, which had, until this advance, been generally inaccessible to clinicians. This subclass information can provide information corresponding to the sizes of the lipoprotein particles that make up a person's lipoprotein constituents.
Lipoprotein subclass information is not part of conventional lipid panels. The conventional panels typically only provided information concerning total cholesterol, triglycerides, low-density lipoprotein (LDL) cholesterol (generally a calculated value), and high-density lipoprotein (HDL) cholesterol. In contrast, the NMR analysis can provide information about (a) the concentrations of six subclasses of very low density lipoprotein (VLDL), four subclasses of LDL (including intermediate-density IDL), and five subclasses of HDL, (b) average LDL particle size (which can be used to categorize individuals into LDL subclass pattern-determined risk), and (c) LDL particle concentration.
The subclass information now available with the NMR spectral analysis can be a more reliable indicator of a patient's risk to develop coronary heart disease. Indeed, recent scientific research has shown that various subclasses of lipoproteins may provide more reliable markers of the metabolic conditions that predispose individuals to a greater or lesser risk of heart disease. However, the NMR spectral analysis can also provide higher-order information about the levels of variously atherogenic or antiatherogenic subclasses that make up each of the major lipoprotein classes.
This subclass information can provide a clear indication about a patient's propensity to develop coronary heart disease. Unfortunately, this additional information can confuse a reviewer as to the meaning of the data, and further, the additional information can be difficult to analyze in a readily discernable manner. For example, a typical NMR lipoprotein analysis can include at least fifteen more values of lipoprotein concentration and size than is provided by standard lipoprotein panels. There is, therefore, a need to analyze and present the lipoprotein-based information in a manner or format which is visually easy to read and understand.
OBJECTS AND SUMMARY OF THE INVENTION
It is therefore an object of the present invention to provide a lipoprotein profile analysis with subclass information with an easily read display format.
It is also an object of the present invention to provide a lipoprotein-based risk assessment which analyzes a patient's measured major lipoprotein constituent values and selected subclass information and presents them in a format in which a patient's specific values are presented in a reader-friendly format.
It is a further object of the present invention to provide a method of generating a custom report at a commercial volume and which can analyze and/or report a patient's risk factors for certain diseases based on NMR spectra of lipoprotein constituents and constituent subclasses.
These and other objects of the present invention are provided by a method for providing and presenting or displaying a customized patient-specific lipid analysis profile with a risk assessment portion for the measured results. In particular, a first aspect of the present invention is directed to a method for providing personalized lipoprotein-based risk assessment information. The method includes the step of generating NMR-based lipoprotein measurement values for a patient's blood plasma or serum sample, the lipoprotein measurement values including at least one subclass variable value. The at least one patient lipoprotein subclass measurement variable value is compared with predetermined test criteria to determine whether the at least one subclass variable value is associated with a higher or lower risk of developing coronary heart disease. The method also identifies what the level of coronary heart disease risk is for the at least one measured subclass variable value. The lipoprotein measurement values are presented in a two-dimensional window such that each of the lipoprotein measurement values are visually enhanced. A risk analysis portion is provided adjacent to the measured lipoprotein values, the risk analysis portion displaying information related to a range of values corresponding to higher and lower coronary heart disease risk. The measured value is visually enhanced in the risk analysis portion to indicate the level of risk associated therewith to thereby provide a contemporaneous reference guideline for interpretation of the measured value. Preferably, the lipoprotein measurement values are presented such that each of the lipoprotein measurement values is substantially vertically aligned and the risk analysis portions are also substantially vertically aligned.
Another aspect of the present invention is directed to a method of presenting NMR derived lipoprotein subclass information in a two-dimensional window. The method includes the steps of obtaining lipoprotein information having a plurality of lipoprotein subclass variable values associated with NMR derived lipoprotein analysis and identifying a risk level associated with coronary heart disease for each of the obtained subclass variable values. The obtained lipoprotein information with subclass values is analyzed to determine the associated risk level. Each of the obtained lipoprotein subclass variable values is arranged in a display format which positions the lipoprotein subclass values adjacent to a corresponding risk analysis portion. The risk analysis portion characterizes the subclass variable value's determined risk level and visually enhances the subclass variable value within the respective risk analysis portion such that the risk associated with the lipoprotein subclass variable value is readily apparent.
An additional aspect of the present invention is an automated lipoprotein report including data corresponding to NMR-derived measurements. The report comprises a first lipid profile segment comprising a plurality of NMR derived major lipoprotein constituent values, each major lipoprotein value having an associated risk analysis portion and a second subclass profile segment comprising a plurality of NMR-derived subclass variables, each subclass variable having an associated risk analysis portion which is configured to visually enhance the risk of developing coronary heart disease for each of said plurality of subclass values, wherein the lipoprotein report is generated at a commercial volume by a computer based on NMR derived patient-specific values.
In a preferred embodiment, each of the major constituent lipoprotein risk analysis portions identifies three risk categories associated therewith. It is also preferred that the risk analysis portion for a plurality of the subclass values is presented as a horizontally extending linear bar graph which graphically represents the subclass value
Gakh Yelena
LipoScience, Inc.
Myers Bigel & Sibley Sajovec, PA
Warden Jill
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