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Isis licensee launches test for statin side effects


31st May 2012

A simple diagnostic test developed at Oxford University and launched today by Massachusetts-based Boston Heart Diagnostics, will identify those at increased risk of rare but serious side effects from taking cholesterol lowering statin drugs. The test is now available for license in non-US territories, including the UK.

Isis Innovation, the University’s technology commercialisation company, granted Boston Heart Diagnostics an exclusive US license to the test in 2011.

Researchers at Oxford University’s Clinical Trial Service Unit, led by Prof Rory Collins, identified the genetic biomarker SLCO1B1, which is an effective identifier of patients at increased risk of myopathy – the onset of muscle aches, pains and weakness associated with statin therapy. This condition can be extremely unpleasant and occasionally become very serious.

“Lowering cholesterol with statin therapy results in a substantial reduction in heart attacks, stroke and cardiovascular mortality and larger reductions in cholesterol produce larger benefits. In rare cases, myopathy occurs in association with statin therapy, especially when the statins are given at higher doses and with certain other medications. Knowledge of the SLCO1B1 marker may help to achieve the benefits of statin therapy more safely and effectively.” said Prof Collins.

Boston Heart Diagnostics has now launched the Statin Induced Myopathy (SLCO1B1) Genotype test. The test classifies individuals into high risk or low risk genotypes based on the presence or absence of the SLCO1B1 biomarker.

“Of course there are any number of reasons that people ignore their healthcare provider’s advice, but statin-induced myopathy can be extremely unpleasant and, for a small percentage, completely debilitating – leading many to forego taking the potentially life-saving drug,” said Boston Heart Diagnostics President and CEO Susan Hertzberg.

“We are delighted to assist in bringing this important new test to the US market through an exclusive arrangement with Boston Heart Diagnostics,” said Tom Hockaday, Managing Director of Isis Innovation. “The test has the potential to allow physicians worldwide to assist patients to choose the best and safest treatment option for their particular case.”

Boston Heart Diagnostics also announced that the US Patent & Trademark Office has approved the patent application for a Prioritized Prosecution on its fast-track patent examination process.

Isis has filed National Phase patents covering the test in other territories including Europe, China and Japan, and is seeking partners to develop the diagnostic method in countries.

For more information:
Renate Krelle
Business Relationship Manager, Isis Innovation
E: renate.krelle@isis.ox.ac.uk
T: +44 (0)1865 280850

A PDF version of this release is available here.

About Isis Innovation

Isis Innovation is the research and technology commercialisation company of the University of Oxford. The Technology Transfer and Oxford University Consulting divisions provide access to technological developments and expertise from University of Oxford researchers, through intellectual property licensing, spin-out company formation, material sales and consulting.

Isis is the highest University patent filer in the UK, has attracted investment into over 65 spin-out companies since 2000, and in the last financial year provided expertise to over 150 clients in 22 countries. Through the Isis Enterprise division, Isis offers innovation management to university, government and industrial clients around the world.
For updates on innovations from Oxford, follow Isis on LinkedIn and Twitter or subscribe at www.isis-innovation.com

About Boston Heart Diagnostics (BostonHeartDiagnostics.com)

Boston Heart Diagnostics focuses solely on cardiovascular disease – the number one cause of death in the United States. It offers clients an unparalleled combination of proprietary tests, actionable information, and dedicated service and support – partnering with healthcare providers so they can provide the best CVD patient care possible. There’s much more to cardiovascular disease than “good” (HDL) and “bad” (LDL) cholesterol. Studies show that traditional statin drug therapy to lower LDL cholesterol reduces the relative risk of heart attack by only 25%. Compelling new research suggests that other measurable proteins and sub-particles are critical to predicting whether a particular patient will have a heart attack or stroke. BHD, established in 2007, targets the 75% relative risk for a cardiovascular event that remains AFTER lowering LDL cholesterol. The company offers a compelling suite of proprietary diagnostics to assess the patient’s health as part of a comprehensive CVD risk profile. Its proprietary algorithm fully parses test results in light of relevant patient history and the latest peer-reviewed scientific data to produce a personalized treatment plan recommending specific therapeutic and lifestyle strategies tailored for each individual patient.
When it comes to CVD management, Boston Heart Diagnostics is leading the charge to turn the promise of personalized medicine into a reality.
http://www.bostonheartdiagnostics.com/science_portfolio_statin.php

The biomarker SLCO1B1 study

The link between the SNP and an increased risk of myopathy is based on a genome-wide association study of approximately 300,000 markers in 85 myopathy cases and matched controls from a trial of 12,000 participants. Replication was confirmed in a second trial of 20,000 participants: “SLCO1B1 Variants and Statin-Induced Myopathy — A Genomewide Study” The SEARCH Collaborative Group, N Engl J Med (2008); 359 : 789-799.
A list of participating UK hospitals can be found in the Supplementary Appendix to the study.


Publisher Contact Information:

Isis Innovation
+44 (0)1865 280850
renate.krelle@isis.ox.ac.uk

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