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NMR-based Diabetes Risk Index (DRI) Helps to Identify Normal-weight Individuals at High Risk of Progressing to Type 2 Diabetes

Data Presented at ADA Scientific Sessions Suggest DRI May Enable More Timely and Focused Risk Assessment and Intervention in At-risk Patients


News provided by

LipoScience, Inc.

Jun 14, 2014, 01:00 ET

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SAN FRANCISCO, June 14, 2014 /PRNewswire/ -- LipoScience, Inc. (NASDAQ: LPDX), a diagnostic company pioneering a new field of personalized nuclear magnetic resonance (NMR) diagnostics to advance the quality of patient care in cardiovascular, metabolic and other diseases, today announced the presentation of data demonstrating the utility of the company's NMR-based diabetes risk index (DRI) in identifying normal-weight individuals at high risk of progressing to type 2 diabetes. The data, presented today in a poster session at the 74th Scientific Sessions of the American Diabetes Association (ADA), suggest that the DRI may enable more timely and focused risk assessment and intervention in at-risk individuals regardless of body weight, potentially preventing or slowing their progression to type 2 diabetes.

"Many clinicians are challenged about how to effectively manage patients with 'intermediate' blood glucose levels ranging from 90 to 110 mg/dL, as within this range there is often ambiguity as to whether a patient will progress to type 2 diabetes," commented Margery Connelly, PhD, Vice President, Translational Research of LipoScience. "The ambiguity is particularly pronounced in normal-weight individuals, who do not typically present with overtly visible risk factors. With our simple-to-use diabetes risk index, clinicians now have a tool to help them identify high-risk patients, providing guidance for implementing targeted risk-reduction strategies."

The DRI is a clinical lab test that uses LipoScience's proprietary NMR-derived markers of insulin resistance, inflammation, and potentially impaired B-cell function to determine a patient's risk of progressing to type 2 diabetes. DRI provides researchers and healthcare providers with the means to assess a patient's risk of progressing to diabetes at any given level of fasting plasma glucose (FPG), glycosylated hemoglobin (HbA1c), or body mass index (BMI).

Using the DRI to identify high-risk, normal-weight patients

In today's poster presentation (1417-P), Dr. Connelly described the development of the DRI.  The investigators used NMR data collected at baseline from participants in the Multi-Ethnic Study of Atherosclerosis (MESA), to develop the DRI assay then used data from and the Insulin Resistance Atherosclerosis Study (IRAS) to verify its ability to stratify a patient's risk of progressing to type 2 diabetes. To determine whether the DRI score was capable of identifying normal-weight individuals with a high likelihood of developing diabetes, the investigators compared the percentage of patients progressing to type 2 diabetes across quartiles of the DRI score in three BMI categories – normal weight (BMI <25), overweight (BMI 25-30), and obese (BMI ≥30). Regardless of the BMI category, as the DRI score increased there was an increased likelihood of becoming diabetic, even for subjects whose BMI was within the normal range.  Furthermore, DRI added predictive value independently of BMI in both the MESA and IRAS populations.

"Even in the absence of being overweight, DRI can help healthcare providers make a more timely prediction of whether a patient is on the path toward developing diabetes, before blood glucose reaches so-called 'pre-diabetes' levels," noted William C. Cromwell, MD, Chief Medical Officer of LipoScience. "By providing more precise risk-assessment information, DRI can facilitate initiation of individualized patient management strategies, while motivating high-risk patients to take steps to lower their risk."

Other ADA presentations

This year's ADA Scientific Sessions also feature the following poster presentations in which LipoScience's NMR spectroscopy was used to develop inflammation and diabetes risk assessment tools:

  • Saturday, June 14, 11:30 am-1:30 pm, poster #1196-P: "Lipoprotein-derived insulin resistance (LP-IR) score in youth." Wilson DP, de la Torre AJ, Shaibi G, Le N-A.
  • Sunday, June 15, 12:00-2:00 pm, poster #1415-P: "Short- and long-term diabetes risk assessed by markers derived from a nuclear magnetic resonance spectrum of fasting plasma." Otvos JD, Shalaurova I.
  • Sunday June 15, 12 pm-2 pm, poster #1345-P: "GlycA complements C-reactive protein as a measure of inflammation: The Insulin Resistance Atherosclerosis Study." Lorenzo, C, Hanley A, et al.
  • Sunday June 15, 12 pm-2 pm Lipoprotein heterogeneity may help to detect individuals with insulin resistance: The Insulin Resistance Atherosclerosis Study (IRAS). Festa, A, Lorenzo, C, Wagenknecht, L, et al.

About LipoScience, Inc.

LipoScience, Inc. (Nasdaq: LPDX) is pioneering a new field of personalized diagnostics based on nuclear magnetic resonance (NMR) technology. The NMR LipoProfile® test, the Company's first proprietary test, is the only FDA-cleared blood test that directly quantifies LDL particles and provides physicians and their patients with actionable information to personalize management of heart disease. To date, more than 11 million NMR LipoProfile tests have been ordered. LipoScience is striving toward the NMR LipoProfile test becoming the preferred choice by physicians for the management of cardiovascular disease

The Vantera® Clinical Analyzer is the first FDA-cleared platform that utilizes NMR technology. Its ease of use and quick turnaround time helps maximize efficiency and throughput in the clinical laboratory. For further information on LipoScience, please visit www.liposcience.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange and Exchange Act of 1934, as amended, that are intended to be covered by the "safe harbor" created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "could," "seek," "intend," "plan," "estimate," "anticipate" or other comparable terms. Forward-looking statements in this press release may address the following subjects among others: our industry, business strategy, goals and expectations concerning our future operations, performance or results, profitability, capital expenditures, liquidity and capital resources, timing or anticipated results of our FDA submissions and other financial and operating information. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and our subsequently filed Quarterly Reports on Form 10-Q. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward -looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

SOURCE LipoScience, Inc.

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