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The next generation of cholesterol screening - A personalized diagnostic index for the improved assessment of cardiovascular risk using a novel method for the measurement of lipoprotein subtypes

Opportunity

This program offers the next generation of cholesterol screening. In 2013, 96 million visits to doctors' offices in the US included a cholesterol test.

Problem/Unmet need

Current practice of measuring total HDL level in serum does not reflect the patient’s true cardiovascular risk. Available cholesterol diagnostics offer imperfect estimations of CVD risk because they measure the total lipoprotein rather than the good and bad functional types.

Innovation/Solution

Harvard’s proprietary platform offers direct measures of disease relevant HDL subclasses and combines them into a personalized index that more accurately predicts individual risk that can provide significant value in treatment decision.

Lipoprotein subtypes defined by their protein cargo are the active species protecting against or contributing to CVD. As demonstrated by Dr. Sacks in several epidemiological studies, lipoprotein apoC-III is a potentially important modifier of HDL function and the presence of apoCIII in HDL is an independent predictor of cardiovascular disease risk.

Value

This new assay will detect patients at risk of cardiovascular events that are not detected by current methods. For example, this assay will correctly identify individuals here-to-fore misclassified as low-risk due to their high overall HDL as being at elevated risk if they have a high proportion of CVD risk associated apoC-III-containing HDL. In addition, the information of this assay can help segregate populations responsive to ApoCIII targeted drugs or certain HDL increasing drugs.

Patents

A portfolio of patent applications has been filed to cover this work including Apo-CIII association with heart disease (3554), methods for detection of HDL subtypes with differential cardioprotective potential (4080), and a personalized HDL Protection Index and Global Lipoprotein Index (4433).

Status

The Sacks lab has developed and optimized a rapid assay for measuring the concentration of HDL with apoC-III using a modified ELISA method. The assay’s ability to predict risk was confirmed in three epidemiological cohorts: MESA, NHS, and HPFS. Currently, the program is focused on increasing throughput of apoC-III assay and development of a personalized index that combines up to 76 protective and harmful HDL subtypes to determine an overall HDL-cardiovascular risk index.

Intellectual Property Status: Patent(s) Pending

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