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News Article | October 29, 2016

Vortex Biosciences, provider of circulating tumor cell (CTC) capture systems, is pleased to announce that Deborah J. Neff has accepted the role as Non-Executive Director. Deborah has served in a number of leadership positions in healthcare companies, including a 15-year career at Becton Dickinson & Co in executive management positions, making her ideally positioned to provide oversight to Vortex Biosciences as it approaches commercialization of its first product, the VTX-1 Liquid Biopsy System. During her time at Becton Dickinson & Co, she was the Worldwide President of BD Biosciences with global P&L responsibilities. Under her leadership, the BD Biosciences grew to be a ~$700M business. Most recently, Deborah was the Chief Operating Officer of Complete Genomics Inc., where she led strategy development, established and delivered financial and operational milestones, and was responsible for operations, commercial and product development. Prior to that she was the President and Chief Executive Officer at both Predicant Biosciences Inc, and at Pathwork Diagnostics Inc., where she led the raising of capital, hiring of the executive team, development of an FDA cleared product, and achieved multi-million dollar annual sales. She was a member of the Board of Directors at Advanced Medical Optics Inc. and ForteBio Corporation Inc. prior to their being acquired, and is currently a member of the Board of Directors at Bio-Rad Laboratories. Her experience in leading both large and small companies in the development and execution of a strategic vision will be a tremendous asset to Vortex. “Deborah will be a very strong addition to the team,” said Gene Walther, Chief Executive Officer of Vortex Biosciences. “Her extensive experience and strategic vision will be a significant contribution to the company.” “I am excited to be joining Vortex Biosciences at this time when the company is moving towards commercialization of their lead asset,” Deborah Neff commented. “I look forward to working with the team during this dynamic time.” The VTX-1 system, with a planned commercial launch in the first quarter of 2017, is a fully automated benchtop system for capturing intact circulating tumor cells (CTCs) directly from whole blood samples without any preprocessing steps. The proprietary Vortex technology uses microvortices to stably capture the larger, more deformable CTCs, while white and red blood cells flow past. Captured CTCs are then released in a 300 µL volume in a container of the user’s choice. Representative of cancer status in the patient, CTCs, shed by tumors, can potentially reveal disease recurrence or disease progression earlier than imaging and more reliably compared with standard biomarkers. About Vortex Biosciences Vortex Biosciences is a cancer research and diagnostics company that integrates cancer biology, microfluidic engineering and informatics to develop tools for isolating and characterizing circulating tumor cells. The Vortex VTX-1 instrument harvests intact circulating tumor cells from whole blood samples for use in downstream research and clinical applications such as patient stratification in clinical trials, monitoring disease progression and drug treatment effectiveness. With a mission to enable noninvasive diagnosis of cancer and real-time monitoring throughout a patient’s treatment, Vortex is at the forefront of accelerating cancer research and improving patient outcomes. Vortex is a core subsidiary of NetScientific plc, a transatlantic healthcare technology group with an investment strategy focused on sourcing, funding and commercializing technologies that significantly improve the health and well-being of people with chronic diseases. For more information, visit

Handorf C.R.,University of Memphis | Kulkarni A.,University of Memphis | Grenert J.P.,San Francisco General Hospital | Weiss L.M.,Clarient | And 8 more authors.
American Journal of Surgical Pathology | Year: 2013

Metastatic tumors with an uncertain primary site can be a difficult clinical problem. In tens of thousands of patients every year, no confident diagnosis is ever issued, making standard-of-care treatment impossible. Gene expression profiling (GEP) tests currently available to analyze these difficult-todiagnose tumors have never been directly compared with the diagnostic standard of care, immunochemistry (IHC). This prospectively conducted, blinded, multicenter study compares the diagnostic accuracy of GEP with IHC in identifying the primary site of 157 formalin-fixed paraffin-embedded specimens from metastatic tumors with known primaries, representing the 15 tissues on the GEP test panel. Four pathologists rendered diagnoses by selecting from 84 stains in 2 rounds. GEP was performed using the Pathwork Tissue of Origin Test. Overall, GEP accurately identified 89% of specimens, compared with 83% accuracy using IHC (P=0.013). In the subset of 33 poorly differentiated and undifferentiated carcinomas, GEP accuracy exceeded that of IHC (91% to 71%, P=0.023). In specimens for which pathologists rendered their final diagnosis with a single round of stains, both IHC and GEP exceeded 90% accuracy. However, when the diagnosis required a second round, IHC significantly underperformed GEP (67% to 83%, P>0.001). GEP has been validated as accurate in diagnosing the primary site in metastatic tumors. The Pathwork Tissue of Origin Test used in this study was significantly more accurate than IHC when used to identify the primary site, with the most pronounced superiority observed in specimens that required a second round of stains and in poorly differentiated and undifferentiated metastatic carcinomas. © 2013 Lippincott Williams and Wilkins.

Pillai R.,Pathwork Diagnostics | Deeter R.,Pathwork Diagnostics | Rigl C.T.,Pathwork Diagnostics | Nystrom J.S.,Tufts University | And 3 more authors.
Journal of Molecular Diagnostics | Year: 2011

Tumors whose primary site is challenging to diagnose represent a considerable proportion of new cancer cases. We present validation study results for a gene expression-based diagnostic test (the Pathwork Tissue of Origin Test) that aids in determining the tissue of origin using formalin-fixed, paraffin-embedded (FFPE) specimens. Microarray data files were generated for 462 metastatic, poorly differentiated, or undifferentiated FFPE tumor specimens, all of which had a reference diagnosis. The reference diagnoses were masked, and the microarray data files were analyzed using a 2000-gene classification model. The algorithm quantifies the similarity between RNA expression patterns of the study specimens and the 15 tissues on the test panel. Among the 462 specimens, overall agreement with the reference diagnosis was 89% (95% CI, 85% to 91%). In addition to the positive test results (ie, rule-ins), an average of 12 tissues for each specimen could be ruled out with >99% probability. The large size of this study increases confidence in the test results. A multisite reproducibility study showed 89.3% concordance between laboratories. The Tissue of Origin Test makes the benefits of microarray-based gene expression tests for tumor diagnosis available for use with the most common type of histology specimen (ie, FFPE). Copyright © 2011 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

Anderson G.G.,Pathwork Diagnostics | Weiss L.M.,City of Hope National Medical Center
Applied Immunohistochemistry and Molecular Morphology | Year: 2010

BACKGROUND: Pathologists use various panels of immunohistochemical (IHC) stains to identify the site of tissue of origin for metastatic tumors, particularly poorly or undifferentiated cancers of unknown or uncertain origin. Although clinicians believe that immunostains contribute greatly to determining the probable primary site among 3 or more possibilities, objective evidence has not been convincingly presented. This meta-analysis reviews the objective evidence supporting this practice and summarizes the performance reported in 5 studies published between 1993 and 2007. METHODS: A literature search was conducted to identify IHC performance studies published since 1990 that were masked, included more than 3 tissues types, and used more than 50 specimens. The 5 studies found in this search were separated into 2 subgroups for analysis: those, which included only metastatic tumors (n=368 specimens) and the blended studies, which combined primary tumors and metastases (n=289 specimens). RESULTS: The meta-analysis found that IHCs provided the correct tissue identification for 82.3% (95% confidence interval=77.4%-86.3%) of the blended primary and metastatic samples and 65.6% (95% confidence interval=60.1%-70.7%) of metastatic cancers. This difference is both clinically and statistically significant. CONCLUSIONS: This literature review confirms that there is still an unmet medical need in identification of the primary site of metastatic tumors. It establishes minimum performance requirements for any new diagnostic test intended to aid the pathologist and oncologist in tissue of origin determination. Copyright © 2009 by Lippincott Williams & Wilkins.

Monzon F.A.,University of Pittsburgh | Medeiros F.,Mayo Medical School | Lyons-Weiler M.,University of Pittsburgh | Henner W.D.,Pathwork Diagnostics
Diagnostic Pathology | Year: 2010

Background. Carcinomas of unknown primary (CUP) represent approximately 3%-5% of malignant neoplasms. Identifying the tissue of origin (TOO) in these tumors allows for more specific treatment and improves outcomes. However, primary classification remains a challenge in many cases. We evaluated the ability of a microarray-based gene expression test to identify the TOO in tumor specimens from 21 patients with a diagnosis of CUP. Methods. The Pathwork® TOO Test was used to measure gene expression patterns for 1550 genes; these were compared for similarity to patterns from 15 known tissue types. Results. The TOO Test yielded a clear single positive call for the primary site in 16 of 21 (76%) specimens and was indeterminate in 5 (24%). The positive results were consistent with clinicopathologic suggestions in 10 of the 16 cases (62%). In the remaining six cases the positive results were considered plausible based on clinical information. Positive calls included colorectal (5), breast (4), ovarian (3), lung (2), and pancreas (2). The TOO Test ruled out an average of 11 primary tissues in each CUP specimen. Conclusion. The Pathwork TOO Test reduced diagnostic uncertainty in all CUP cases and could be a valuable addition or alternative to current diagnostic methods for classifying uncertain primary cancers. © 2010 Monzon et al.

Pathwork Diagnostics | Date: 2012-06-27

A computer having a memory stores instructions for receiving data. The data comprises one or more characteristics for each cellular constituent in a plurality of cellular constituents that have been measured in a test organism of a species or a test biological specimen from an organism of the species. The memory further stores instructions for computing a model in a plurality of models, wherein the model is characterized by a model score that represents the likelihood of a biological feature in the test organism or the test biological specimen. Computation of the model comprises determining the model score using one or more characteristics for one or more cellular constituents in the plurality of cellular constituents. The memory also stores instructions for repeating the instructions for computing one or more times, thereby computing the plurality of models. The memory also stores instructions for communicating computed model scores.

News Article | May 20, 2010

As someone who has been covering cloud computing since the dawn of Amazon’s Elastic Compute Cloud (EC2) I’m constantly in education mode about what is and isn’t cloud computing. To borrow an analogy from my Forrester colleague Ted Schadler’s keynote at last year’s IT Forum, the challenge is a lot like helping blind men discern an elephant through just the parts of the animal they can reach. One feels the trunk and declares it a cylindrical, yet hairy and warm snake. The other calls it a strong, tough and deeply rooted tree upon feeling its hind leg. Each examiner brings their own experience and context to the challenge as well as their own judgments, then leaps to the conclusion that best fits their desires. Many IT ops pros see the cloud as competition and quickly race to its flaws, declaring it unsafe and immature while they scheme for how to duplicate its benefits – rapid provisioning, shared infrastructure – within their own data center. Others quickly conclude that it is nothing more than virtualization and thus relabel their VMware environment “private cloud.” Each vendor looks at cloud from within its own context declaring it either “something we’ve been offering to the market for years” or a natural outgrowth of their core value – even if the value of cloud is clearly tangential or even well beyond what they offer. The result: all are making dangerous leaps of logic that skip over the true change cloud computing represents and put all at risk of disruption. Cloud computing, especially in the form of Infrastructure as a Service (IaaS) and Platform as a Service (PaaS) are evolutionary steps in hosting that change both the deployment model and the business value of IT in profound ways. Those that acknowledge this and accept what truly is different about it stand to gain the most from it. But let’s be clear, cloud computing isn’t your future – it’s a new part of your overall IT portfolio. There are lots of definitions out there purporting the scope and architecture of cloud but what’s important is to focus on what makes cloud computing a new and unique value. Simply painting pre-existing services with a wash of cloud helps no one. The fundamentals of cloud computing are more important to understand than the basic words of a definition, as they are clearly open to interpretation in the same way the elephant becomes a snake or a tree. First off, let’s get one thing straight. Cloud might be another word for the Internet, but cloud computing isn’t another word for services delivered over the Internet. We already have plenty of words for those – Internet services and web services for starters. It’s combining cloud with computing that draws out the distinction, as cloud computing is about cloud-enabling your business services via abstracted components deployed at virtual scale. Read here how Pathwork Diagnostics is creating new market value via cloud computing. There are three core fundamentals to cloud computing which distinguish it from traditional IT and other Internet services that bring forth its different business value: I know a lot of you will argue with these fundamentals and I encourage that discussion here, via Twitter and through your own blogs. I will be defending these fundamentals in my keynote address at next week’s IT Forum by showing how your peers – enterprises, innovative startup companies and leading vendors – are leveraging cloud computing to differentiate themselves and maximize profitability. They aren’t cloudwashing, they’re cloud enabling their businesses. I’ll show you how you can follow in their footsteps. And on Friday during the Forum (and at our IT Forum EMEA in Lisbon in June), I’ll walk you through the ROI of cloud computing so you can sell the value up the chain. I’ll also help you understand how cloud isn’t the sole future of IT and why you shouldn’t try to move everything to the cloud. Or you can choose to ignore what’s different about true cloud computing. Keep your head in the sand, cloud wash your existing services and fight for relevancy. But know that doing so exposes you and your company to the risk of being passed by those who are truly harnessing this innovation. We hope to see you at Forrester’s IT Forum next week.

News Article | February 16, 2011

Forrester took over a thousand inquiries from clients on cloud computing in 2010 and one of the common themes that kept coming up was about which applications they should plan to migrate to Infrastructure as a Service (IaaS) cloud platforms. The answer: Wrong question. What enterprises should really be thinking about is how they can take advantage of the economic model presented by cloud platforms with new applications. In fact, the majority of applications we find running on the leading cloud platforms aren't ones that migrated from the data center but were built for the cloud. A lot of the interest in migrating applications to cloud platforms stems from the belief that clouds are cheaper and therefore moving services to them is a good cost savings tactic. And sure, public clouds bring economies of scale shared across multiple customers that are thus unachievable by nearly any enterprise. But those cost savings aren't simply passed down. Each public cloud is in the profit-making business and thus shares in the cost savings through margin capture. For enterprises to make the most of a public cloud platform they need to ensure their applications match the economic model presented by public clouds. Otherwise the cloud may actually cost you more. In our series of reports, "Justify Your Cloud Investment" we detail the sweet spot uses of public cloud platforms that fit these new economics and can help guide you towards these cost advantages. But job one when building a strategy for IaaS success needs to focus on new applications and services which can be built to take advantage of these economics best. We all know that clouds deliver agility, letting your developers gain access to resources and build new services faster and at lower cost. More abstracted services such as Platforms as a Service (PaaS) and discrete cloud services that can be integrated with custom code running on IaaS and PaaS can speed up time to market even more. But understanding the cost model and mapping that to the revenue model associated with the services you are building is key to making the most of these investments. This is how NetFlix, the Associated Press, Pathwork Diagnostics, NVoicePay and hundreds of other companies are improving their profitability by building anew for the cloud. They are taking payment before spending to fire up certain services; splitting services between pay-per-use and subscription platforms based on which give the right cost advantage to what parts of the application; and spinning up services on demand and rapidly turning them off when not needed. In many cases the new services being created in the cloud are directly tied to revenue generation - delivering value in new ways, accelerating business insight so costs can more quickly be identified and taken out, or finding vastly cheaper ways to do what has been done before. The reason the business (and not IT) does this is because it understands how revenue is generated and how the costs of the business impact the profitability of the company. We in IT often have no clue how the actions we take, the applications we build and how we operate them affect the profitability of our companies products and services or the business bottom line. Sure we may know what percent of company spend goes to IT but do we know the cost breakdown for our top 3 services or products and what we contribute to them? If the business came to us with an idea for a new service do we honestly believe we could advise them on how that service could be built most cost effectively? How many of you could propose a new service to the business and show the profit impact of that investment? Could you explain the profit impact of doing it in-house versus in the cloud? If you don't understand how the economics differ between public clouds and in-house deployment you cant have this conversation. And if you can't, you might just be asked to help far less in the future. At Forrester's Enterprise Architecture Forum in San Francisco this week, I'll be leading an interactive session on cloud economics where we will discuss the tools cloud platforms provide for affecting service profitability and how you can apply them to your business. If you are putting applications in the cloud, bring those stories so we can discuss them and make them better. I look forward to seeing you there.

News Article | October 6, 2010

Pathwork Diagnostics is applying new discoveries in genomics to unmet clinical needs in oncology. Using proprietary technologies, Pathwork Diagnostics plans to harness the power of genomics information to develop FDA-cleared microarray-based tests that provide physicians with clinically actionable information not available with current diagnostic methods.

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