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Independent Study: Health Diagnostic Laboratory, Inc. Services Lead to Cost Savings of 23% and Significantly Improved Health Outcomes After Two Years

Advanced cardiometabolic testing paired with follow-up health management from Health Diagnostic Laboratory, Inc. has resulted in a 23 percent decrease in a patient’s overall healthcare costs and an improved lipid profile in just two years, according to a new independent study published recently in Population Health Management.

Health Diagnostic Laboratory, Inc.’s New Diabetes Prevention & Management Panel Incorporates Discovery from Metabolon Researchers

Health Diagnostic Laboratory, Inc., a CLIA-certified laboratory specializing in advanced cardiovascular and metabolic disease testing and health management, has launched a new blood test for stratifying prediabetic patients based on the Quantose™ insulin resistance markers discovered by Metabolon, Inc.

Insulin resistance is a primary risk factor for type 2 diabetes and cardiovascular complications, and the Quantose biomarkers have been incorporated into HDL, Inc.’s newly launched Diabetes Prevention & Management Panel, or DPMP. Following a soft-launch period of limited release, development, and test marketing, HDL, Inc. has incorporated the Quantose™ metabolites seamlessly into DPMP, a 21-test panel available to physicians nationwide beginning this month. Terms of the deal were not disclosed.

“The ability to more accurately identify patients likely to progress to full-blown type 2 diabetes is a powerful tool to help manage the onset of a leading cause of heart disease,” said Tonya Mallory, HDL, Inc.’s President, CEO and Co-founder. “The Quantose markers help complete Health Diagnostic Laboratory’s DPMP and provide physicians with a more accurate, deeper look at the root causes of prediabetes and diabetes.”

Diabetes affects 25.8 million people in the U.S., or 8.3 percent of the population, according to the American Diabetes Association. Nearly one in three U.S. adults – almost 80 million people – meet the criteria for prediabetes.

The Quantose™ biomarkers are novel metabolites detected in blood that reflect insulin resistance and detect progression to prediabetes and diabetes earlier than traditional glycemic measures such as HbA1c. By considering insulin resistance, metabolites provide clinicians with a useful tool that goes beyond traditional measures to stratify patients based on their risk for developing diabetes. The Quantose™markers are particularly useful in identifying prediabetic patients at the greatest risk of disease progression where drug or other interventional therapy may be appropriate. Such a clinical value is well-aligned with American Diabetes Association guidelines, which recommend physicians consider pharmaceutical intervention in high-risk prediabetic patients.

”We are delighted to have an ideal partner in Health Diagnostic Laboratory to bring American clinicians a new tool for identifying and managing patients at risk for developing diabetes,” said John Ryals, CEO of Metabolon. “Our expertise in biochemical profiling is reflected in the discovery of the Quantose markers and represents the culmination of many years of research by our scientists. Importantly, if physicians are able to detect high-risk prediabetic patients earlier, it may allow them to initiate therapeutic interventions capable of preventing diabetes and related complications. The launch of Health Diagnostic Laboratory’s DPMP using the Quantose markers also represents a significant milestone in Metabolon’s evolution from providing biomarker analysis services to discovering cutting-edge metabolomic-based diagnostic markers.”

Source: PR Newswire

The Medicines Company and Alnylam Form Strategic Alliance to Develop and Commercialize RNAi Therapeutics Targeting PCSK9 for the Treatment of Hypercholesterolemia

The Medicines Company (Nasdaq: MDCO) and Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, recently announced that they have formed an exclusive global alliance for the development and commercialization of Alnylam’s ALN-PCS RNAi therapeutic program for the treatment of hypercholesterolemia.

“This new alliance unites two organizations with a shared culture and commitment to innovation. In my view and past experience, there could be no stronger partner for our ALN-PCS program than The Medicines Company, which has demonstrated industry-wide leadership in the advancement of cardiovascular medicines to patients and remarkable success in its strategy of in-licensing, developing, and commercializing breakthrough products,” said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. “For Alnylam, this new partnership enables the advancement of ALN-PCS, an important program within our ‘Alnylam 5×15’ product development and commercialization strategy focused on RNAi therapeutics directed toward genetically validated targets. We believe that the ALN-PCS program holds great promise for the development of a significant therapeutic option for patients with hypercholesterolemia, and that the unique mechanism of action for ALN-PCS could provide a differentiated and potentially best-in-class strategy for PCSK9 antagonism.”

“Our focus on acute and intensive care medicine has led us to a leadership position with Angiomax® (bivalirudin) and potentially with cangrelor in the management of patients in extreme risk as a consequence of the rupture of their vulnerable coronary artery plaque at and around the time of acute coronary syndromes. Meantime, we have made progress with MDCO-216 (ApoA-1 Milano), a turbocharged form of HDL-C (‘good cholesterol’) which has the potential to modify disease through reverse cholesterol transport,” said Clive Meanwell, M.D., Ph.D., Chairman and Chief Executive Officer of The Medicines Company. “Now, this exciting collaboration with Alnylam – leaders in their field of RNAi – adds a second potentially disease modifying approach and more cutting edge technology to our portfolio. We have seen that PCSK9 gene silencing can substantially reduce LDL-cholesterol in patients and has epidemiological and disease mechanisms studies suggest this can further reduce the risks of the world’s number one killer, coronary artery disease. Clearly we see the complementarity of approaches which increase ‘good cholesterol’ (HDL-C) and decrease ‘bad cholesterol’ (LDL-C). We look forward to working with our colleagues at Alnylam for whom we have the greatest respect and admiration based upon earlier collaborations particularly around Angiomax, which was invented by John Maraganore.”

PCSK9 (proprotein convertase subtilisin/kexin type 9) is a protein that regulates low-density lipoprotein (LDL) receptor levels on hepatocytes; gain-of-function human mutations in PCSK9 are associated with hypercholesterolemia while loss-of-function mutations are associated with lower levels of LDL cholesterol and a reduced risk of cardiovascular disease. ALN-PCS is a PCSK9 synthesis inhibitor that reduces intracellular and extracellular levels of PCSK9 resulting in lowered plasma levels of LDL-C. MDCO-216 is a naturally occurring variant of a protein found in high-density lipoprotein, or HDL. It is a reverse cholesterol transport agent designed to reduce atherosclerotic plaque burden development and thereby reduce the risk of adverse thrombotic events.

Under this alliance, The Medicines Company and Alnylam intend to collaborate on the advancement of the ALN-PCS program. Alnylam’s ALN-PCS program includes ALN-PCS02 – an intravenously administered RNAi therapeutic which has completed a Phase I trial, and ALN-PCSsc – a subcutaneously administered RNAi therapeutic currently in pre-clinical development. Alnylam will continue the program for an estimated one to two years to complete certain pre-clinical and Phase I clinical studies. The Medicines Company is responsible for leading and funding development from Phase II forward and commercializing the ALN-PCS program if successful. Under the terms of the agreement, The Medicines Company will make an upfront cash payment of $25 million to Alnylam. Alnylam may also receive potential development and commercial milestone payments of up to $180 million. Alnylam will be eligible to receive scaled double-digit royalties on global products sales of ALN-PCS products.

Alnylam has completed a Phase I trial of ALN-PCS02 in healthy volunteer subjects with elevated baseline LDL-C. Results showed that administration of a single intravenous dose of drug, in the absence of concomitant lipid-lowering agents such as statins, resulted in statistically significant and durable reductions of PCSK9 plasma levels of up to 84% and lowering of LDL-C of up to 50%. ALN-PCS02 was shown to be generally safe and well tolerated in this study and there were no serious adverse events related to study drug administration. Alnylam has also presented pre-clinical data from its ALN-PCSsc program demonstrating potent knockdown of the PCSK9 target gene with an ED50 of less than 0.3 mg/kg after a single subcutaneous dose.

“Cardiovascular disease remains the leading cause of mortality worldwide, with elevated LDL-C a major modifiable risk factor. New strategies are needed to dramatically and rapidly reduce LDL-C and prevent acute cardiovascular events that result from the rupture of cholesterol rich plaque when patients are at their most vulnerable,” said Daniel J. Rader, M.D., professor of Medicine and chief, Division of Translational Medicine and Human Genetics, at the Perelman School of Medicine at the University of Pennsylvania. “As a key regulator of the LDL receptor, liver-expressed PCSK9 is one of the most important and best validated new targets in molecular medicine for the treatment of hypercholesterolemia. The ALN-PCS data generated to date are very encouraging and I look forward to continued clinical studies that highlight the unique mechanistic approach of PCSK9 synthesis inhibitors.”

Dr. Rader serves as a member of Alnylam’s Scientific Advisory Board and as a consultant on Alnylam’s ALN-PCS program, and Alnylam and Dr. Rader collaborate on research for which Alnylam provides materials.

Source: The Medicines Company

Shiel Medical Laboratory’s Oxidized LDL Triple Marker Test Uncovers Symptoms of Latent Heart Disease Better than Standard Lipid Test

The primary clinical laboratory test used by physicians to identify patients with coronary artery disease (CAD) fails to measure oxidized low-density lipoprotein (LDL), the plaque-specific protein directly involved in the disease process. A key study demonstrated that nearly half the patients with documented coronary events had LDL cholesterol readings within healthy range, exposing a major weakness in the standard lipid panel and the need for measuring oxidized LDL levels.

Shiel Medical Laboratory’s Oxidized LDL Triple Marker Test is the only blood test that measures oxidized LDL, which reflects atherosclerotic disease activity in the arterial wall. As an identifier of clinical and subclinical CAD, the test is superior to any other laboratory test available to assess patient risk of cardiovascular disease, which kills 400,000 Americans annually and costs $110 billion in medical services and lost productivity.

“Research studies show measuring LDL cholesterol alone is insufficient to determine whether a patient is at risk for heart attack or stroke,” said Shiel Medical Laboratory Technical Services Director, Harold M. Bates, Ph.D., who was involved in the commercial development of the oxidized LDL test. “Oxidized LDL as a biomarker test could easily become the successor to the regular LDL test because of its greater clinical efficacy.”

Shiel’s Oxidized LDL Triple Marker Test overcomes the weaknesses of conventional lipid tests by measuring oxidized LDL, a plaque-specific protein. Oxidized LDL is the atherogenic form of LDL cholesterol linked to the deposition of plaque in the artery walls. The CAD disease process depends on the oxidation of LDL, making oxidized LDL the primary culprit molecule in cardiovascular disease.

In addition to oxidized LDL, the Oxidized LDL Triple Marker Test measures two additional biomarkers linked to CAD: HDL cholesterol, an anti-atherogenic substance that inhibits the disease-causing action of oxidized LDL; and high-sensitivity C-reactive protein (hs-CRP), an independent biomarker that at certain lower levels is associated with cardiovascular disease.

Like oxidized LDL, hs-CRP is not included in the standard lipid panel even though elevated oxidized LDL and chronically elevated hs-CRP may explain why half of all patients hospitalized with CAD have lipid readings that appear normal.(1)

In published medical studies assessing known and emerging lipid biomarkers, oxidized LDL measurements rendered the most accurate snapshot of CAD risk. A 2006 study of 921 subjects, including 490 CAD patients and 431 healthy individuals in the control group, compared the relative potency of oxidized LDL to LDL cholesterol in identifying patients with CAD.(2 )Oxidized LDL showed a six-fold ability over LDL cholesterol in indicating disease. Measuring the oxidized LDL/HDL ratio and adding hs-CRP levels to round out the Triple Marker profile produced a 16-fold ability over LDL cholesterol in identifying CAD disease.

“Every physician needs to know that standard lipid panels do not measure elevated oxidized LDL even in patients with low to moderate LDL. I’m certain more patients would request the Oxidized LDL test if they knew how much more effective it is in detecting CAD than the standard LDL test,” said Charles Mitgang, M.D., an internist in Rockville Centre, N.Y. “The test has become part of my routine in identifying, treating and monitoring patients who are at risk for CAD.”

Shiel Medical Laboratory is the first and only laboratory to develop the automated Oxidized LDL Test and establish reference ranges allowing physicians to better interpret results. Shiel introduced the test in 2006, following lab validation and approval by the New York State Department of Health. The laboratory exhibits annually at Scientific Sessions for the American Heart Association and the American College of Cardiology and researchers and clinicians have embraced this lipid biomarker test as a much-needed addition to the cardiac disease prevention arsenal.

Source: PR Newswire

Novel Apolipoprotein A-I Therapy, CSL112, May Represent New Option for Reducing Recurrent Heart Attack Risk, Early CSL Studies Show

Infusions of a novel formulation of apolipoprotein A-I (apoA-I) – the main component of high-density lipoprotein (HDL) – rapidly increased the presence of key biomarkers associated with reverse cholesterol transport, a process by which cholesterol is removed from arteries and transported to the liver for clearance, according to data from a Phase 1 study sponsored by CSL Limited. Rapid removal of cholesterol following a heart attack may play a role in stabilizing vulnerable plaque lesions and lowering the high risk of subsequent attacks.