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Critical Diagnostics’ Biomarker ST2 Included in the 2013 ACC/AHA Guidelines for the Management of Heart Failure

Critical Diagnostics announced today that the American College of Cardiology Foundation/American Heart Association Task Force jointly released its expanded clinical practice guideline for the management of patients with heart failure and has identified ST2 “not only predictive of hospitalization and death in patients with HF [heart failure] but also additive to natriuretic peptide levels in [its] prognostic value.”

The American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) have jointly produced guidelines in the area of cardiovascular disease since 1980. The guidelines are designed to assist clinicians in selecting the best management strategy for heart failure patients, and have been adopted by most U.S. cardiologists and followed by many other countries in developing their practice guidelines.

“Having ST2 included in the 2013 ACC/AHA Guidelines is unprecedented,” notes David Geliebter, CEO of Critical Diagnostics. “We only received FDA clearance in December of 2011. No cardiac biomarker that we know of has ever achieved this acceptance so quickly.”

Source: Critical Diagnostics

Pathway Genomics to Launch Next-Generation Sequencing (NGS) Comprehensive Cancer Panel Including BRCA1 and BRCA2

Pathway Genomics, a genetic testing laboratory on the forefront of bringing physicians a broad genetic testing portfolio covering a wide range of diseases, announces the pending launch of its inherited cancer panel with BRCA1 and BRCA2.

Pathway Genomics’ Hereditary Cancer DNA Insight test utilizes next-generation sequencing (NGS) technology and will analyze genes related to a selection of hereditary cancers including breast, ovarian, colorectal and others. The company notes that it intends to introduce all their cancer panels in August 2013.

“I am delighted to see laboratories like Pathway offering genetic tests for inherited cancers,” said Linda Wasserman, M.D., Ph.D., former Director of the Clinical Cancer Genetics Care Unit at Moores UCSD Cancer Center. “Next-generation sequencing is a critical step in making actionable genetic information more accessible to the physician, ultimately benefitting the patient.”

Inherited BRCA gene mutations are responsible for approximately five percent of breast cancers and about 10-15% of ovarian cancers. Patients who have deleterious BRCA mutations may also have increased risk of other cancers.

Jim Plante, President and CEO of Pathway said, “Pathway is committed to innovation in health care and to improving the health of millions of patients with increased risk of developing cancer. We believe Pathway Genomics’ Hereditary Cancer DNA Insight is an important test in our genetic portfolio and it will enable the medical community to progress towards more personalized health care at an affordable price.”

Pathway Genomics’ genetic tests screen patient DNA using advanced technologies to provide scientifically-validated and actionable information for a wide range of genetic and inherited diseases including recessive diseases, traits that impact heart health, drug response and nutrition.

Source: Pathway Genomics

Saladax Receives CLIA Laboratory Certification and Approval to Begin Clinical Laboratory Operations in Support of MyCare Portfolio

Saladax Biomedical, Inc., a privately held company developing novel diagnostic tests that individually optimize a patient’s exposure to chemotherapy, today announced it has been certified as a registered CLIA Laboratory from the Office of Clinical Standards and Quality (OCSQ), a division of The Centers for Medicare & Medicaid Services (CMS) that regulates laboratory testing performed on humans. The CLIA certification and approval marks a significant milestone for Saladax, allowing the company to begin clinical laboratory operations for the MyCare™ portfolio of products at its facilities located in Bethlehem, PA.

Saladax Biomedical Laboratories (SBL), a division of Saladax Biomedical, Inc., will initially offer testing services for chemotherapy exposure optimization assays including My5-FU™, MyPaclitaxel™ and MyDocetaxel™ in the U.S. SBL’s menu of testing services will expand to include more than a dozen new exposure optimization tests that are currently in development.

“This is a significant milestone for SBL as our CLIA laboratory operations are at the heart of our U.S. commercialization plan that will include an expanding suite of MyCare exposure optimization tests that we believe give cancer patients the edge they need with their therapy,” said Mark Myslinski, SVP and Chief Commercial Officer at Saladax Biomedical, Inc. “The SBL team did an outstanding job preparing our company for this milestone and it is illustrative of their preparedness for the commercial launch of the MyCare portfolio to oncologists in the U.S.”

Beginning on July 1, 2013, SBL will offer testing services for their initial chemotherapy exposure test portfolio, MyPaclitaxelTM, MyDocetaxelTM and the My5-FUTM test (previously OnDose) that is being transitioned from Myriad Laboratories. The MyCare technology platform offers, rapid, robust and cost-effective blood tests for patient-specific chemotherapy dose optimization.

As a simple blood test, MyCare products will provide oncologists with vital information to determine the optimal chemotherapy dose required to maximize effectiveness and limit toxicity for their patients on an individual basis.

About Saladax Biomedical, Inc.
Saladax Biomedical develops novel diagnostic assays for the practical delivery of personalized medicine. The company’s proprietary line of MyCare™ assays improves the efficacy of existing drugs by optimizing the dose administered for each individual patient. The initial focus of Saladax is oncology, with a portfolio of 13 chemotherapy drug assays in various stages of development. The initial portfolio of three assays is currently offered to the oncology community in markets around the world.

The company’s MyCare technology platform is broad and flexible, enabling wide application in many therapeutic categories. This technology also enables Saladax to serve as a valuable partner to pharmaceutical and biotechnology companies in the development of companion diagnostics (CDx), addressing multiple risks and challenges encountered in drug development.

Headquartered in Bethlehem, Pennsylvania, Saladax was founded in 2004 and is ISO 13485:2003 certified.

Source: Saladax Biomedical

Two Biomarkers Predict Increased Risk for “Silent” Strokes

Two biomarkers widely being investigated as predictors of heart and vascular disease appear to indicate risk for “silent” strokes and other causes of mild brain damage that present no symptoms, report researchers from The Methodist Hospital and several other institutions in an upcoming issue of Stroke (now online).

The researchers found high blood levels of troponin T and NT-proBNP were associated with as much as 3 and 3.5 times the amount of damaged brain tissue, respectively. The findings are part of the large-scale Atherosclerosis Risk in Communities (ARIC) study, funded by the National Heart, Lung, and Blood Institute.

“The concept of prevention is expanding,” said principal investigator Christie Ballantyne, M.D., director of the Center for Cardiovascular Disease Prevention at The Methodist Hospital. “It’s not good enough to simply do a few tests and try to assess risk for heart attack. What we need to do is assess the risk for heart attack, stroke, heart failure and also asymptomatic disease so we can start preventive efforts earlier. Waiting to correct problems until after a symptomatic stroke may be too late.”

One possible outcome is that patients determined to be in high-risk groups could be started on anti-stroke medications sooner.

In another ARIC paper published two months ago in Stroke, Ballantyne and coauthors reported a strong association between blood levels of troponin T and NT-proBNP and more severe instances of stroke, called symptomatic stroke. The current study looked at the two biomarkers and “subclinical,” asymptomatic events in the brain that are usually caused by a lack of blood flow.

“Taken together, these two papers show the biomarkers are effective at identifying people who are likely to have mild brain disease and stroke well before damage is done,” said Ballantyne, who also is a Baylor College of Medicine professor. “This hopefully will give doctors more time to help patients take corrective steps to protect their brains.”

For the subclinical brain disease study, researchers gleaned data from about 1,100 patient volunteers who agreed to have blood drawn and two MRI scans eleven years apart to look for silent brain infarcts and also white matter lesions (WMLs) caused by chronic inflammation.

Statistical analysis showed a strong relationship between high NTproBNP and the likelihood of brain infarcts and WMLs. Study participants with the highest levels of NT-proBNP had as much as 3.5 times the number of brain infarcts as participants with low NT-proBNP levels, and more WMLs. Those with the highest levels of troponin T had as much as 3.0 times the number of brain infarcts and more WMLs.

The protein troponin T is part of the troponin complex and its presence is often used to diagnose recent heart attacks. NT-proBNP is an inactive peptide fragment left over from the production of brain natiuretic peptide (BNP), a small neuropeptide hormone that has been shown to have value in diagnosing recent and ongoing congestive heart failure.

“The highly sensitive troponin T test we used is not approved for general clinical use in the US yet, but the NT-proBNP test is just now starting to be used more widely beyond making a diagnosis for heart failure,” Ballantyne said.

The Center for Cardiovascular Disease Prevention is part of the Methodist DeBakey Heart & Vascular Center.

Also contributing to this study were Razvan Dadu, Salim Virani, Vijay Nambi, and Ron Hoogeveen (Baylor College of Medicine and Methodist Center for Cardiovascular Disease Prevention), Myriam Fornage and Eric Boerwinkle (University of Texas Health Sciences Center at Houston), Alvaro Alonso (University of Minnesota School of Public Health), Rebecca Gottesman (Johns Hopkins School of Medicine), and Thomas Mosley (University of Mississippi Medical Center). It was funded with grants from NHLBI and NIH, while Roche Applied Science helped fund the development of diagnostic technology.

Stroke is published by the American Heart Association and American Stroke Association.

Source: Cardiovascular Biomarkers and Subclinical Brain Disease in the Atherosclerosis Risk in Communities Study.

Source: Troponin T, N-terminal pro-B-type natriuretic peptide, and incidence of stroke: the atherosclerosis risk in communities study.

Source: The Methodist Hospital System

Decades of Improving Cholesterol Levels Abruptly Ended in 2008, PLOS ONE Study Finds

Decades of declines in LDL cholesterol blood levels, a key marker of death risk from heart disease, abruptly ended in 2008, and may have stalled since, according to a multi-year, national study published recently in PLOS ONE.

The study, by researchers at Quest Diagnostics (NYSE: DGX), examined low-density lipoprotein, or LDL, blood-serum cholesterol test results of nearly 105 million individual adult Americans of both genders in all 50 states and the District of Columbia from 2001-2011. The study is the largest of LDL cholesterol levels in an American population, and the first large-scale analysis to include data from recent years 2009-2011.

“Our study suggests that significant improvements in heart disease risk through declines in LDL cholesterol blood levels over the past several decades came to an unexpected and sudden end in 2008,” said investigator Robert Superko, M.D., medical director, cardiovascular disease, Quest Diagnostics. “The unprecedented scale of our data set should spur additional research to identify the cause or causes in order to prevent a possible reversal in years of gains in cardiovascular health in the U.S. population.”

The study found a net 13% decline in the annual mean LDL cholesterol level of the study population over the 11-year period. Between 2001 and 2008, the average age-adjusted mean LDL levels declined from about 120 mg/dL to 104.7 mg/dL, but plateaued at that level for the remainder of the study period. LDL levels of 100 mg/dL or lower are considered optimal by the American Heart Association. By 2011, about 46% of patients had achieved LDL levels lower than 100 mg/dL, while 6% of patients had LDL levels in the high-risk category of 160 mg/dL or higher.

Blood cholesterol levels are the primary biomarker for cardiovascular disease, which accounts for one in every three deaths in America. High levels of LDL (“bad”) cholesterol can cause arterial clogging, increasing the risk of stroke and heart disease. Treatments typically include lifestyle modification and therapy with lipid-lowering medications such as statins. Every 10 mg/dL decline in LDL is associated with an approximately 5-13% decline in major vascular disease events, such as strokes and mortality.

Prior research, including results of three National Health and Nutrition Examination Surveys (NHANES) of nearly 40,000 patients for the years 1988 to 2010, demonstrated that LDL levels have declined in the United States while the use of lipid-lowering medications has increased.

The Quest Diagnostics Health Trends study, “Blood Cholesterol Trends 2001-2011 in the United States: Analysis of 105 Million Patient Records,” was published online May 10, 2013 in the peer-reviewed, open-access journal PLOS ONE.

Theories for the LDL Plateau

The observational study in PLOS ONE did not identify a cause for the trends in LDL cholesterol blood levels, although investigators suggested several hypotheses.

“It is possible that the economic recession that began at about the same time LDL values plateaued in our study played a role. Patients dealing with financial constraints may have been less inclined to visit their physician or use their medications at full dose, limiting access to and effectiveness of treatment. Individuals may also have experienced changes in stress levels, diet, sleep and other behaviors, due to the poor economy, which in turn may have adversely impacted lipids,” said Harvey W. Kaufman, M.D., senior medical director, Quest Diagnostics.

The investigators also theorized that statins users in the study may have reached the maximum therapeutic-threshold level or that increases in obesity prevalence or other co-morbid factors during the 11 years of the study period contributed to the LDL plateau.

“These speculative, but plausible theories deserve additional research so the cause of the trend seen in our data can be addressed and hopefully reversed,” said Dr. Kaufman.

Gender Differences

The investigators also found differences in LDL cholesterol declines by gender. The decline in annual age-adjusted mean LDL cholesterol blood levels was slightly greater among men than women, with an average 13.4% decline for men compared to a decline of 12.5% for women.

“Though the differences are not statistically significant, they may reflect meaningful differences in the prescription rate and effectiveness of lipid-lowering interventions, including statins and lifestyles, between genders,” wrote investigators in the study. They also theorize that the differences may be due in part to “under-appreciation of heart disease risk in women,” given female-specific AHA guidelines and risk-classification algorithms for women were introduced only in 1999 and 2007, respectively.

Greater Vigilance Required

“Like other Quest Diagnostics Health Trends reports, our goal is to provide insights, based on diagnostic data, to enhance public health and patient management and, fundamentally, create a healthier world,” said Dr. Kaufman.

“We believe this new study will encourage additional population research to inform public health efforts. But we also believe the study should prompt individual patients to be vigilant about practicing healthy behaviors and lipid-lowering treatment plans. Our hope is physicians and patients will have more productive conversations about the importance of LDL control to cardiovascular health as a result of this study,” said Dr. Kaufman.

The study’s strengths include its size, national representation, longitudinal analysis and incorporation of data up through 2011. It also includes its separation of data into distinct years, as opposed to other large-scale studies, such as NHANES, which group findings into multiple years. The study represents patients under medical care and not the general American population and did not include results of clinical records, such as medical history and medications, to assess contributing factors to the results. The study examined test results of patients tested by Quest Diagnostics. Data was de-identified prior to analysis and the Western Institutional Review Board exempted the study from review.

Study: Blood Cholesterol Trends 2001–2011 in the United States: Analysis of 105 Million Patient Records

Source: Quest Diagnostics