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Proteome Sciences Announces $2.1m Contract with Thermo Fisher Scientific

Proteome Sciences recently announced its largest contract to date, a technology agreement with Thermo Fisher Scientific, valued at $2.1million by Proteome Sciences, to develop advanced methods to profile changes in key cancer pathways. Proteome Sciences will provide Thermo Fisher with access to its patents covering a three-stage mass spectrometry (MS3) fragmentation methodology to deliver significantly improved analysis and accuracy. Proteome Sciences will receive cash and Thermo Fisher will provide a no-cost lease for mass spectrometry equipment for Proteome Sciences to develop the pathway assays. In addition Proteome Sciences will continue to develop advanced 20 and 30-plex Tandem Mass Tags (TMT®) for Thermo Fisher for the next additions to the TMT® range of tags.

The new MS3 TMT® (three-stage MS Tandem Mass Tag) mass spectrometry technique is a breakthrough mass spectrometry based workflow, enabling mass spectrometers to determine relative quantitation of proteins in multiple samples simultaneously and with improved accuracy.
“We are at a critical juncture toward the development of personalised medicine which requires high-resolution maps of the protein networks regulating disease,” said Dr. Ian Pike, Chief Operating Officer at Proteome Sciences. “The combination of the highest sample multiplexing rates from TMT with the industry-leading Thermo Scientific Orbitrap mass spectrometer enables us to provide an unrivalled platform to investigate subtle but significant changes in the proteome.”
Proteome Sciences will leverage the combined power of TMT® and Orbitrap® technology to develop an expanded range of mass spectrometry assays for the pharmaceutical industry. Through its SysQuant® workflows, Proteome will profile the low-level changes in activity of key cancer signalling pathways to facilitate optimal drug selection across a range of solid tumours. This will enable clinicians to provide real-time patient management and the ability, for the first time, to deliver truly personalised medicine.

“Life sciences researchers today need to perform high-quality relative quantitation of many samples quickly,” said Ian Jardine, Chief Technology Officer, Chromatography and Mass Spectrometry, Thermo Fisher Scientific. “MS3 TMT® technology greatly improves quantitative accuracy and throughput, while Orbitrap® technology dramatically increases depth and quality of data. This agreement offers customers a new paradigm in proteomics research.”
“Our agreement with Thermo Fisher sets a new benchmark to establish and apply novel diagnostic and prognostic strategies in healthcare management,” said Christopher Pearce, Chief Executive of Proteome Sciences. “It has long been our goal to provide clinicians the tools they need to provide early diagnosis of disease and better match molecular targeting medicines to the most likely responders. The output from this agreement should have a profound positive impact on the lives of large numbers of patients suffering from chronic diseases and, at the same time, provide considerable economic benefits to the health care system.”

Source: Proteome Sciences

Abbott Announces New Test to Help Doctors Determine Personalized Treatment Path for Patients with Hepatitis C

Abbott recently announced that it has introduced the first FDA-approved hepatitis C virus (HCV) genotyping test for patients in the United States. Abbott’s fully automated RealTime HCV Genotype II test determines the specific type or strain (referred to as the genotype) of the HCV virus present in the blood of an HCV-infected individual. Genotyping the HCV virus provides physicians with important information they can use to create a personalized, targeted diagnosis and treatment path to improve clinical outcomes.

“Hepatitis C is known as the silent killer as many of the symptoms go unnoticed. When patients are identified, determining their specific genotype is important to ensuring they receive the treatment that will prove to be most effective. The introduction of this test for broad use in the U.S. is a significant advancement in helping to address an important public health issue,” said HIV and viral hepatitis expert, Carol Brosgart, M.D., Clinical Professor of Medicine, Division of Global Health, University of California San Francisco.

According to the Centers for Disease Control and Prevention (CDC), more than 75 percent of adults with hepatitis C are baby boomers — born between 1945 and 1965 — and most of them don’t know they are infected. In 2012, the CDC recommended that all baby boomers talk to their doctor and get a one-time test for HCV since this group is five times more likely to have the virus. Once a patient is diagnosed with HCV, a doctor would order a hepatitis C genotype test. The Abbott RealTime HCV Genotype II test is run on the fully automated m2000 platform, which provides laboratories substantial improvements in workflow efficiency to meet the increased demand.

“The Abbott RealTime HCV Genotype II test adds yet another test to the Abbott portfolio for a full spectrum of hepatitis C testing—from ensuring blood supply safety and providing initial screening to enabling targeted diagnoses, identification of the right treatments, and the monitoring of response to therapies,” said John Coulter, vice president, Molecular Diagnostics, Abbott. “Abbott continues to expand diagnostic testing options in the infectious disease area to benefit the healthcare system and enable doctors to improve patient care.”

Source: Abbott

Cambia Health Solutions and GNS Healthcare to Co-Develop Next Generation Medication Adherence Platform Using Big Data Analytics

Cambia Health Solutions and GNS Healthcare recently announced they are collaborating to build a platform for harnessing data-driven predictive models focused on medication adherence. The partnership will focus on predicting Meaningful Adherence™ – identifying where improving medication adherence can have the most meaningful impact on clinical and cost outcomes.

The Cambia family of companies includes leading health plans across the Northwest and Intermountain regions. The platform’s models will use real-world data provided by the health plans to determine the following:

  • Highly-individualized predictions of which specific medications, if not taken sufficiently, are most likely to cause adverse outcomes
  • What modifiable factors, if changed, could improve adherence the most
  • Which members are or will soon be most at risk

Poor medication adherence is defined as patients not taking their medications as prescribed or in some cases, not taking them at all. It has significant and wide- ranging cost impacts on the health care system. According to a meta-analysis published October 7, 2012 in The Annals of Internal Medicine poor medication adherence is estimated to be responsible for between $100-$289 billion in annual healthcare costs, 33% of medication-related hospital admissions, between 30-50% of treatment failures, and 125,000 deaths each year. Low medication adherence is especially a problem for those with chronic disease, and the problem will only get worse, as the number of people with at least one chronic condition is expected to grow to 157 million by 2020, according to the Centers for Disease Control.

“The burdens from poor medication adherence, both to individuals and to the healthcare system as a whole, are enormous, but addressing them is absolutely within our reach,” said Carol McCall, Chief Strategy Officer at GNS. “In fact, some organizations have called improving patient adherence ‘the next frontier in patient care.’ Our Meaningful Adherence™ platform is creating a unique set of capabilities that help make patient adherence a reality by making it possible to accelerate the development of highly individualized, data-driven and evidence-based innovations that improve adherence and create the most value.”

The Meaningful Adherence™ platform will harness GNS’s REFS™ modeling framework. Using REFS™ to learn models of the underlying relationships in the data, the platform can make individualized predictions of when higher adherence is vital.

“Cambia is committed to identifying innovations that support our vision for an economically sustainable health care system. We are excited to take this significant step forward by partnering with GNS to make this vision a reality,” said Richard Popiel, M.D., Executive Vice President of Health Care Services and Chief Medical Officer for Cambia Health Solutions. “For the first time, we’ll be able to directly pinpoint relationships between medication adherence and medical costs and create tailored clinical programs that will help improve members’ health and lower their overall health care costs.”

Source: GNS Healthcare

SAP and Technical University Munich Decode Human Proteome and Make Data Available for Biomedical Research

SAP AG (NYSE: SAP) and Technical University Munich (TUM) recently announced ProteomicsDB, a new offering based on the SAP HANA® platform that stores protein and peptide identifications from mass spectrometry-based experiments. The proteomic data assembled in the new offering resulted in the identification of proteins mapping to over 18,000 human genes. This represents 90 percent coverage of the human proteome. Data stored and analyzed within ProteomicsDB can be used in basic and biomedical research for discovering therapeutic targets and developing new drugs as well as enhanced diagnosis methods.

As personalized medicine is on the rise, the healthcare field is discovering the opportunities of big data analysis. The result of a joint project between the TUM Chair of Proteomics and Bioanalytics, SAP and the SAP Innovation Center, ProteomicsDB is a major step forward in human proteomics. It currently contains more than 11,000 datasets from human cancer cell lines, tissues and body fluids and enables real-time analysis of this highly dimensional data and creates instant value by allowing to test analytical hypothesis.

ProteomicsDB is based on the SAP HANA for rapid data mining and visualization. It has been built to enable public sharing of mass spectrometry-based proteomic datasets as well as to allow users to access and review data prior to publication. The database is backed with 50 TB of storage, 2 TB RAM and 160 processing units. A direct interface to the programming languages L, C++ and R allows more flexible calculations than are possible with standard SQL. The Web interface is built on a JavaScript framework for HTML5 and optimized for Google Chrome but also available under Internet Explorer and Mozilla Firefox. An easy-to-use and fast Web interface allows users to browse and upload data to the repository as well as browsing the human proteome, including protein level information such as protein function and expression.

ProteomicsDB will be available free of charge. The database will be a valuable asset for researchers in the field of life sciences as well as for the pharmaceutical and biotechnology industry. Insights from analyzing the inherent datasets can be used in biomedical research and for example in developing new drugs that operate in a more targeted way without adversely influencing other cellular processes, helping to reduce side effects.

“The vast amounts of molecular data generated in biomedical research increasingly challenge the ability of scientists to see ‘the forest for the trees,” said Prof. Dr. Bernhard Kuster of TUM. “ProteomicsDB is a significant step ahead in our research aiming at a better understanding of human disease and more informed future treatments. The software helps us and others to store, integrate and analyze experimental data in real time, allowing us to study more complex biological systems at greater depth than previously possible.”

Source: SAP

Vermillion’s OVA1 Receives New Statement by Society of Gynecologic Oncology

Vermillion, Inc.’s (NASDAQ: VRML), a multivariate diagnostics company focused on gynecologic cancers and women’s health, OVA1® has received a new statement on clinical validation and medical use issued by the Society of Gynecologic Oncology (SGO).

Citing peer-reviewed publications from two pivotal clinical studies of OVA1® versus standard of care, the statement also referred to OVA1 use within the context of the American Congress of Obstetricians and Gynecologists’ (ACOG) 2011 Committee Opinion, “The Role of the Obstetrician-Gynecologist in the Early Detection of Epithelial Ovarian Cancer.” This guideline, updated from a previous version issued in 2002, covers the management of adnexal masses, including serum markers for ovarian cancer detection.

SGO stated: “…The test may be useful in identifying women who should be referred to a gynecologic oncologist. Recent data have suggested that the OVA1 test along with physician clinical assessment may improve detection rates of malignancies among women with pelvic masses planning surgery.” The complete statement on OVA1 clinical validation and medical use is available on SGO’s website here.
This second SGO statement on OVA1 since its FDA clearance in 2009 represents another significant step toward acceptance of OVA1 as the standard of care for pre-surgically evaluating the risk of ovarian cancer in women with adnexal masses.

The new statement does two things:

  • Refers to publications of OVA1’s two pivotal clinical studies, comprised of the original FDA validation study published in June 2011 and the OVA500 “intended use” study published in 2013. Together, this offers an extensive, peer-reviewed proof source for physicians and payers to assess OVA1’s clinical performance and comparative medical benefits versus today’s standard of care.
  • Places OVA1 use in the context of current ACOG practice guidelines, where CA125 has been used off-label for many years to predict malignancy before surgery, although with inferior performance.

Two key developments in 2013 underlined the timeliness of this updated statement by SGO. The first was the publication of the company’s second pivotal clinical study, OVA500, in the February edition of Gynecologic Oncology. OVA500 was led by Dr. Robert E. Bristow, director of Gynecologic Oncology Services at UC Irvine Healthcare in Orange, California. The second development was a study in the June edition of the journal Obstetrics and Gynecology, which made the front page of the New York Times under the headline, “Widespread Flaws Found in Ovarian Cancer Treatment.” This study, also led by Dr. Bristow, reported that most women with ovarian cancer “are treated by doctors and hospitals that see few cases of the disease and lack expertise in the complex surgery and chemotherapy that can prolong life.” Dr. Bristow said, “If we could just make sure that women get to the people who are trained to take care of them, the impact would be much greater than that of any new chemotherapy drug or biological agent.”

After reviewing the SGO statement, Dr. Hector Chapa, MD, FACOG and medical director of the Women’s Specialty Center in Dallas observed: “This new statement by SGO affirms the important role which OVA1 should play in the workup of patients with an adnexal mass, and particularly before surgery is undertaken by a surgeon uncertified in the gynecologic oncology specialty. This is important because a large number of malignancies are discovered after a surgery where the mass was thought to be benign after negative CA125 or physical examination. Now, we await an updated guideline from ACOG, replacing CA125 with the greatly improved sensitivity and negative predictive value of OVA1. After all, ACOG first mentioned excitement about OVA1 in the Gynecology Practice bulletin of March 2011, prior to publication of the two clinical studies cited by SGO. I believe the new SGO statement is a very positive advance for patients, physicians and health insurance companies alike.”

Vermillion President and CEO Thomas McLain commented: “We highly value the support SGO has provided in two statements about the benefits of OVA1 testing. For patients with ovarian cancer, Vermillion understands that timely access to a trained gynecologic oncology specialist is critical. Optimal treatment, survival and post-surgical outcomes all depend upon improvements in the detection of ovarian malignancies of all types, and as early as possible. OVA1 directly addresses the difficult challenge of identifying the more than 22,000 ovarian malignancies that are associated with 300,000 gynecologic surgeries performed every year. We look forward to supporting ACOG’s review of this new clinical data and the SGO statement. We are committed to working to improve the standard of care for all gynecologic surgery patients at risk of ovarian cancer.”

Source: PR Newswire