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Data Sharing Pivotal to Personalized Medicine

Challenges associated with sharing and synthesizing massive amounts healthcare data to improve patient outcomes emerged as a key theme in a   discussion last week on the future of personalized medicine.

The event at the Bipartisan Policy Center in Washington, D.C. urged doctors, policy experts and healthcare-technology leaders to explore ways to advance the field —informing those in attendance and online, as well as shaping a policy brief the center will issue this fall. Notable sound bites and other insights were shared in real-time on Twitter using #personalizedmedicine through a Dell initiative to expand the reach of the discussion to a worldwide virtual audience.

Better, cheaper healthcare

Significant advancements in personalized medicine, which includes genomics, is making it easier for practitioners to tailor medical treatments and preventive strategies to the characteristics of each patient — advancements that supporters say will improve care and reduce costs. Yet progress is being slowed by a number of factors, including the limited sharing of patient information.

Greater sharing would allow medical institutions that are creating patient databases — some with genomic information — to expand the size of the patient pool, thus making it more likely to identify and treat rare conditions, panelists said. It would also allow patients to personally store and share their data with different practitioners, increasing portability. The day that everyone will have every detail about their personal health on their smartphones didn’t sound that far off.

Mollie H. Ullman-Cullere, who structures genomic data in IT systems according to emerging standards, said the federal government is taking steps toward sharing more information with patients, but more effort is needed. She cited a rule change that will allow patients to obtain test results directly from labs.

“How government is addressing healthcare reform is through patient engagement and informing them as active consumers of healthcare,” she said. “Genetics has to be included in that.”

Big data for doctors

The other component of the data-accessibility issue is how medical researchers should go about building massive databases of patient records. The ultimate application is a big-data program that could analyze a patient’s data against similar patients and generate a course of action for the physician.

But with greater access comes privacy concerns, and a need to persuade policymakers and the public at large that the medical community can be trusted with storing and using patient data for the greater good, some panelists said. Data can help practitioners diagnose patients more accurately and quickly, and identify risk factors much earlier. Both capabilities would lower healthcare costs.

Edward Abrahams, president of the Personalized Medicine Coalition, said he’s noticed a vexing dichotomy that policymakers will need to address in order to boost the amount of information that patients share with medical databases.

“The tricky part is that the public wants control over information, but as patients they may think differently,” he said.

Source: Tech Page One

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 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

Harmony Prenatal Test Now Being Offered in Mexico for Safe and Timely Risk Assessment of Chromosome Conditions During Pregnancy

Ariosa Diagnostics announced the offering of its Harmony™ Prenatal Test in Mexico through a partnership with Advance Medical on August 22, making the Latin American nation with over 2 million live births one of 46 countries around the world where the Harmony Prenatal Test can be ordered by healthcare providers. The Harmony test enables clinicians throughout Mexico to offer a non-invasive, early, reliable blood test to pregnant women. The Harmony test is both safe and cost effective, providing a personalized risk assessment for chromosome conditions such as Down syndrome.

The Harmony test has an accuracy rate above 99% for evaluation of fetal trisomy 21 risk, and a false positive rate of 0.1%, which is 50 times lower than conventional serum screening, translating into fewer referrals to unnecessary invasive diagnostic procedures such as amniocentesis that carry the inherent risk of miscarriage.

According to Dr. Dora Gilda Mayen Molina, Medical Genetic Specialist at the Hospital Angeles Lomas and Hospital Angeles Mexico, “The Harmony Prenatal Test can be performed for women with pregnancies of at least 10 weeks gestational age, and it is available for any singleton or twin pregnancy, including all those conceived by IVF.”

A recent study published in the American Journal of Obstetrics and Gynecology provided new evidence that non-invasive prenatal testing, specifically the Harmony test, is effective for screening in the general population. In the study of more than 2,000 women undergoing routine screening for fetal trisomies, the Harmony Prenatal Test accurately assessed the risk of all cases of fetal trisomy 21 and 18, with a false positive rate of 0.1 percent.

According to Dr. Thomas Musci, vice president of clinical and medical affairs for Ariosa Diagnostics, this partnership will “allow us to bring the highest quality and most clinically validated prenatal test to patients in Mexico for the betterment of prenatal medicine. We are very pleased to have partnered with Advance Medical.”

Source: PR Newswire

Caris Life Sciences Expands Global Reach of its Tumour Profiling Service to Middle East and Africa

Caris Life Sciences™, a leading biosciences company focused on fulfilling the promise of personalized medicine in oncology, recently signed a distribution agreement with IPS Genomix to facilitate patient access to its tumour profiling service, Molecular Intelligence™, in select Middle Eastern and African markets. Given this region’s continued investment in healthcare, Caris is uniquely positioned to provide a growing community of oncologists the most relevant and actionable biomarker information to help individualise cancer care.

“The Middle Eastern and African markets represent key areas of unmet medical need and commercial opportunity for Caris Life Sciences, and demonstrate a significant leap forward for our international global expansion plans,” said Ian Walker, Vice President – International at Caris Life Sciences. “Partnering with IPS Genomix offers us a large, diverse and experienced team to help realize our goal to bring Caris Molecular Intelligence to patients and physicians across the globe.”

Caris Molecular Intelligence™ uses multiple evidence-guided profiling technologies — IHC, FISH/CISH, PCR and Next-Generation Sequencing – to provide oncologists with the most relevant, clinically actionable treatment information to help them personalise care for their patient. By identifying the biomarkers unique to a patient’s tumor, Caris can help the physician develop a treatment plan ranging from commercially available agents to active, openly enrolling clinical trials in the patient’s geography. Caris’ multi-technology approach assesses the molecular biology of a tumor in order to better understand the gene and protein alterations that may be driving its growth. Testing of multiple clinically relevant analytes in a tumor is typically most applicable for patients with aggressive, rare or refractory cancers where standard-of-care guidelines have been exhausted or are unclear, or where additional clinical trial options are desired.

“With more than 25 years of experience in the Middle Eastern and African healthcare markets and the dedicated diagnostics sales, marketing, customer service and medical expert teams needed to successfully interface with the local oncology community, IPS Genomix is an ideal partner to Caris as it strives to broaden the reach of its tumour profiling service,” said Ahmed Yacout, Chairman and CEO of IPS Group. “Our vision is to have a life-changing impact on our community by democratizing access to global health solutions.”

Source: Caris Life Sciences