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Thermo Fisher Scientific and Siemens Renew Partnership for Improved Detection of Sepsis Using B·R·A·H·M·S PCT Biomarker

Hospital laboratories outside the U.S. can benefit from a continued availability of the B·R·A·H·M·S PCT™ assay on ADVIA Centaur® systems, allowing them to diagnose sepsis early and safely.

Thermo Fisher and Siemens Healthcare Diagnostics renew their non-exclusive, long-term, royalty-bearing agreement for the use of Thermo Fisher’s Procalcitonin (B·R·A·H·M·S PCT™) technology, currently available as an automated immunoassay on the Siemens ADVIA Centaur® XP and CP systems in all countries outside the United States and China. The agreement extends a long-standing relationship between the companies.

ADVIA Centaur® B·R·A·H·M·S PCT™ immunoassay currently offers clinicians an integrated solution for accurately diagnosing sepsis and monitoring response to antibiotic therapy allowing for improved clinical decision making. The ADVIA Centaur® systems have a large global installed base in hospital clinical laboratories.

The PCT biomarker test is the gold standard for the early detection of sepsis in critically ill patients and is recommended to initiate, monitor and discontinue antibiotic treatment in the presence of relevant bacterial infections. Broader availability of PCT testing will lead to improved hospital management and care of patients with sepsis or at high risk of developing it.

“The continuation of our close collaboration with Siemens significantly increases the global reach of this critical biomarker, making it available to a broader patient population,” said Marc Tremblay, president of Thermo Fisher Scientific’s Clinical Diagnostics division. “The key for preventing sepsis is the early diagnosis of infections. Early diagnosis also reduces the health economic burden of sepsis therapy, a medical condition that is still very common today and accounts for hundreds of thousands of deaths each year. Therefore, PCT supports hospitals in optimizing their service levels and cost effectiveness in today’s challenging economic environment.”

The worldwide number of patients affected by sepsis is estimated to be 20 to 30 million annually and claims more lives than bowel and breast cancer combined. Despite advances in modern medicine, including antibiotics and vaccines, sepsis remains the primary cause of death from infection with hospital mortality rates between 30 to 60%1. Hospital costs to treat severe sepsis in the U.S. are estimated at $16 billion dollars annually. Much of this cost is attributed to misdiagnosis or delayed diagnosis, making rapid, more reliable detection a national, if not global, imperative. Research published in Critical Care Medicine showed that each hour of delay in therapy can decrease chances of patient survival by 7.6 percent.

Source: ThermoFisher Scientific

New Data Suggests Abbott’s High Sensitive Troponin Test May Help Doctors More Accurately Diagnose Heart Attacks in Women

Abbott recently announced promising preliminary results from a study presented at the ESC Congress 2013, suggesting that its high sensitive troponin test may help doctors improve the diagnosis and prognosis of patients presenting with symptoms of a heart attack. The test could be particularly beneficial for women, who may have different presenting symptoms and are often under-diagnosed. The study, which is being conducted by researchers at the University of Edinburgh, is evaluating Abbott’s ARCHITECT STAT High Sensitive Troponin-I (hsTnI) test, which received CE Mark in January 2013.

Cardiac troponin, a protein found in the heart muscle, is considered the preferred biomarker to identify suspected heart attacks, because it can detect injury to the heart.3 Abbott’s hsTnI test can measure very low levels of this protein, which is especially important for women, who often have lower levels of troponin than men.4

Researchers shared data from the first 1,126 patients of the study presenting with symptoms of a heart attack. Early findings demonstrate that women have lower peak levels of troponin than men, contributing to the under-diagnosis and therefore under-treatment of heart attacks for women.

“Whilst men and women are just as likely to present to the emergency department with chest pain, currently men are twice as likely to be diagnosed with a heart attack. By using the Abbott high sensitive troponin test and different diagnostic thresholds for men and women, the frequency of diagnosis of heart attacks in women increased and was comparable to men,” said Dr. Nicholas Mills, one of the key study authors and cardiologist, University of Edinburgh. “The findings of our study, when completed, could change the way we diagnose heart attacks in women, potentially reducing inequalities in the treatment and outcomes, and enabling everyone to receive the best care.”

When completed in 2016, this study will include more than 25,000 patients across 10 centers in Scotland, making it one of the largest studies to evaluate the impact of high sensitive troponin tests on patient care. The study was funded by a special project grant from the British Heart Foundation with Abbott providing the ARCHITECT STAT hsTnI assay.

“While Abbott’s high sensitive troponin test benefits both men and women with earlier detection of heart attacks, the potential to increase the diagnosis among women is especially important,” said John Frels, PhD, divisional vice president, Diagnostics Research, Abbott. “This is the first time we have seen a test that can provide this kind of detailed information to doctors and has the potential to aid doctors with improving the odds of survival for women with heart attacks.”

The ARCHITECT STAT hsTnI assay is commercially available in several countries in Europe, as well as Canada, Australia, New Zealand, and Brazil and runs on Abbott’s fully automated ARCHITECT family of analyzers. The test is currently for research-use only in the United States.

Source: Abbott Diagnostics

Researchers Develop Rapid, Cost-effective Early Detection Method for Organ Transplant Injury

A recently reported blood test for the early detection of organ transplant injury could enable more timely therapeutic intervention in transplant patients and thus help to avoid longer term damage. As described by scientists at the University Medical Center Göttingen and Chronix Biomedical, a molecular diagnostics company, the new method uses Bio-Rad Laboratories’ Droplet Digital PCR (ddPCR™) technology to overcome the obstacles of earlier tests, which were both time-consuming and costly. The method was presented at the American Association of Clinical Chemistry (AACC) 2013 annual meeting and has been accepted for publication in Clinical Chemistry.

Approximately 28,000 organ transplantations (known as grafts) are performed each year in the U.S., with another 100,000 patients on waiting lists. However, transplant patients are often subject to organ rejection: acute rejection of liver transplants within three years is nearly 22 percent, while heart and lung rejection is close to 50 percent. In addition, nearly half of all of kidney transplants fail within 10 years.

Graft-derived cell-free DNA (GcfDNA) in the circulation of transplant recipients is a potential rejection biomarker. But previous attempts to determine GcfDNA, which require parallel sequencing of donor and recipient DNA, are expensive and require a long turnaround and use of donor DNA. University Medical Center Göttingen and Chronix Biomedical researchers sought to develop a new method in an attempt to address these drawbacks.

Using ddPCR for Fast, Cost-Effective Test

The researchers applied Bio-Rad’s ddPCR technology to quantify graft-derived cfDNA in recent liver transplant patients and in stable patients who had undergone a transplant procedure more than six months earlier. ddPCR technology allowed them to develop a cost-effective and fast laboratory test that detects cfDNA being released into the blood stream by dying cells from the transplanted organ.

“GcfDNA from dying graft cells are the most direct and sensitive indicator of organ rejection and we needed an instrument that could measure it,” said Chronix Biomedical’s Chief Technology Officer and the study’s senior author, Ekkehard Schuetz, MD, PhD. “ddPCR added an additional level of reliability and precision to traditional PCR.”

Sequencing methods typically require batch sampling, but by using ddPCR, researchers are able to run single samples. Additionally, this method is reducing test time from three days or more to one day and costs by 90 percent. The study authors were able to address the need for donor DNA by preselecting SNPs that ensure enough heterogeneity between donor and recipient. The new blood test can also deliver results up to several days before the conventional aspartate aminotransferase (AST) and bilirubin tests for liver transplantation rejection, with the potential for an immediate positive impact on patient care.

“We will now be able to detect subclinical rejection and early intervention may allow us to avoid a full-blown rejection,” said Michael Oellerich, M.D., FACB, FRCPath and Lower Saxony Distinguished Professor of Clinical Chemistry at the University Medical Center Göttingen and study Principal Investigator. “This test may be useful to personalize immunosuppression and to improve long-term outcomes.”

“Detecting non-host cfDNA is the third example for the commercial potential of cfDNA diagnostics. Researchers will now be able to extend the applications from fetal cfDNA in maternal blood and personalized biomarkers for minimal residual disease in cancer to solid organ transplantation,” said Howard Urnovitz, PhD, Chronix Biomedical’s Chief Executive Officer.

“We are looking forward to the improvements in precision medicine we can offer with ddPCR and this example in transplantation highlights the diagnostic value for the technology,” said Paula Stonemetz, Director Diagnostic Business Development, Digital Biology Center, Bio-Rad Laboratories.

The researchers were awarded a National Academy of Clinical Biochemistry (NACB) Distinguished Abstract Award at the 2013 AACC annual conference. The results are part of a larger planned study to determine if cfDNA is the earliest indication of a transplant organ rejection.

Source: EurekAlert!

New Test for Cancer Researchers Targets Important Tumor-suppressor Protein

As researchers push to develop more customized diagnostics and therapies for solid tumor cancers, they demand increasingly sensitive tests that offer reliable, reproducible analysis. Spring Bioscience, Inc. (Spring) recently announced a new addition to its specialized portfolio of valuable antibodies for cancer research with the introduction of the Anti-PTEN (SP218) rabbit monoclonal immunohistochemistry (IHC) antibody.

PTEN is a common protein found in most tissues of the body. The protein acts as part of a critical cell signaling pathway that tells cells to stop dividing, helping to prevent uncontrolled cell growth that can lead to the formation of tumors. Mutations in the PTEN gene, together with other factors resulting in loss of PTEN protein, are a step in the development of many human cancers, including prostate and colon cancer. PTEN mutations are also believed to be the cause of a variety of inherited predispositions to cancer.

“With SP218, we’re seeking to set a new gold standard across the industry by offering an extremely sensitive, highly specific antibody optimized for IHC testing that will allow researchers and pathologists to interpret PTEN status with utmost confidence,” says Spring General Manager Michael Rivers. “For our customers, this means we’re continuing to offer unparalleled value through superior tests that lead the market in innovation, reliability and quality.”

Spring internal comparison studies demonstrated that SP218 provides more accurate, sensitive, and specific detection compared to similar research use only (RUO) tests on the market today.

Samples from more than 100 cases of primary prostate and colon cancer showed 100 percent concordance for PTEN loss among Spring’s SP218 and the leading commercially-available PTEN RUO tests; however, competitor tests exhibited some undesirable non-specific staining in IHC testing, while SP218 demonstrated highly specific staining in cells with and without PTEN expression.

“SP218’s robust and consistent performance with IHC analysis is particularly important given PTEN’s potential as a companion diagnostic biomarker,” adds Rivers. “Spring Bioscience is owned by Ventana Medical Systems, Inc., a member of the Roche group, and serves as an Antibody Center of Excellence for Roche’s companion diagnostics development to advance our goal for Personalized Healthcare.”

“Several pharma partners have embraced SP218 as their go-to antibody for PTEN IHC and are including it in their clinical trials as a potential companion diagnostic,” says Doug Ward, VP and Lifecycle Leader, Ventana Companion Diagnostics. “In addition, the Ventana Translational Diagnostics CAP/CLIA Laboratory is now using SP218 as their preferred RUO test for PTEN protein expression.”

Spring is known across the research industry for its quality development practices and for delivering a consistent supply of highly-specific antibodies. SP218 meets the company’s high standards as a valuable tool for assessing PTEN loss.

Source: Spring Bioscience

Abcodia Licenses the ‘Risk of Ovarian Cancer Algorithm’ (ROCA) Developed at Massachusetts General Hospital and Queen Mary, University of London

Abcodia, the biomarker validation company with a focus on screening for cancer, today announced that it has entered into an agreement for an exclusive world-wide commercial license to the Risk of Ovarian Cancer Algorithm (ROCA) developed at Massachusetts General Hospital (MGH) and Queen Mary, University of London.

ROCA has the potential to be a major breakthrough for the early diagnosis of ovarian cancer. The diagnosis of ovarian cancer is usually made when the disease has spread outside the ovaries and as a result the outcome is poor. In the 80% of cases of ovarian cancer in which diagnosis occurs in the later stages, the 5-year survival rate is less than 20%. If diagnosed early, 5-year survival exceeds 85%. Hence the need for early diagnosis, in the hope that current treatments will be more effective. Around the world, an estimated 200,000 new cases of ovarian cancer are diagnosed in women each year and there are over 125,000 deaths.

ROCA is a test being validated for the screening of ovarian cancer. It was invented by Professor Ian Jacobs, Dean & Head School of Medicine, Faculty of Medical & Human Sciences, University of Manchester, and formerly of Queen Mary, University of London, and Dr Steven Skates of the Biostatistics Center, MGH, who together studied longitudinal patterns of CA125 in multiple cohorts of post-menopausal women to develop a statistical algorithm efficiently combining information in age and serial CA125 levels. ROCA has since shown excellent specificity, Positive Predictive Value (PPV) and sensitivity in large studies including UKCTOCS (UK Collaborative Trial of Ovarian Cancer Screening) and UKFOCSS (UK Familial Ovarian Cancer Screening Study).

A recent study by the MD Anderson Cancer Center in normal risk postmenopausal women reported a specificity of 99.9% and a PPV of 40% for ROCA when ultrasound was used as a secondary test. This confirms, in a USA population, results previously reported by the larger UKCTOCS trial involving 202,000 normal risk postmenopausal women. The published results from UKCTOCS2 indicate that, as well as achieving high specificity and PPV, ROCA can achieve a sensitivity of 89% for screen detection of ovarian cancer. UKCTOCS is a randomised trial comparing screening with standard care, and in 2015 will provide results on the impact of screening with ROCA on mortality and survival from ovarian cancer. The final data from UKCTOCS will be of great importance in guiding future clinical use of the ROCA in clinical practice.

Commenting on the recent MD Anderson publication, Professor Ian Jacobs, also Director of the UKCTOCS trial, said: “I am delighted to see the outcome of the MD Anderson 11 year study. The results reassuringly confirm in a USA setting those reported from the UKCTOCS prevalence study published in 2009. We now await further data from UKCTOCS in 2015 to establish whether the encouraging specificity and sensitivity data translate into improvements in survival and mortality which through early detection can help women affected by ovarian cancer.”

Dr Julie Barnes, Abcodia’s CEO, said: “The licensing of ROCA is a significant opportunity for Abcodia and we now intend to work with the co-founders to actively plan a commercialisation path that will in due course enable ROCA to be made available to women in Europe, US and around the world. We are currently in active discussions with partners in different territories to support our mission. Based on the reports to date, and in particular the sensitivity, specificity and PPV data, we will begin to explore ways in which the ROCA could be implemented in clinical practice. The eventual clinical use will of course be informed and guided by the outcome of UKCTOCS and other clinical trials.”

Source: Abcodia