Siemens Healthineers has recently been commissioned to take over the clinical laboratory service operations for two new hospitals in Turkey built and operated as Public Private Partnership (PPP) of DiA Holding and Turkish Ministry of Health. The five-year contract grants a minimum of close to 30 million Euros in revenues. The amount is based on a guaranteed annual test volume, and is expected to reach up to over 100 million Euros revenue based on the anticipated test volumes. Siemens Healthineers will assume the laboratory services for all medical laboratory disciplines (Biochemistry, Microbiology, Hematology, Immunology, Emergency, Genetics, Pathology and Point of Care testing) within these hospitals. Siemens Healthineers also will provide the design, medical and technical equipment, appliances, consumables, service and maintenance, in addition to laboratory technical staff. “This project combines our expertise in equipping laboratories with our service portfolio. It is a proof point for how we enable our customers to meet their current challenges and to excel in their respective environments. The new business model is designed to support our customers in increasing efficiency and containing costs right from the beginning,” said Bernd Montag, Chief Executive Officer, Siemens Healthineers. This order will strengthen our portfolio and is consistent with our strategy.”
Siemens Healthineers will operate the laboratories at the hospitals in Bilkent, Ankara, and in Mersin in partnership with lab doctors from Turkey’s Ministry of Health. Both hospitals are being built by DiA Construction, a subsidiary of DiA, for the Turkish Ministry of Health as a public-private partnership.  The new hospitals are intended to improve healthcare as part of a Turkish government programme to restructure the country’s healthcare system, which was initiated in 2003. It is expected that around 92 million patients will benefit from the partnership over the next five years”.
According to the Turkish government, the Bilkent health campus — with almost 3,800 beds and an affiliated hotel, congress centre and commercial area — is the largest project in the healthcare sector ever constructed from scratch in the country. Beginning in mid-2018, more than 10,000 medical staff will be responsible for nearly 25,000 patients there on a daily basis. The new hospital in Mersin will hold about 1,300 beds and has become operational at the end of January 2017.
www.siemens.com/healthineers

More than 3,000 medical laboratory industry professionals expected to attend the launch edition of MEDLAB Europe at the Fira Gran Via in Barcelona, Spain. 

After many years of operating successful MEDLAB events around Africa, Asia and the Middle East, Informa Life Sciences Exhibitions has announced that the MEDLAB Series will be expanding its presence into Europe. Taking place at the Fira Gran Via in Barcelona, Spain, from 13-15 September 2017, more than 3,000 industry professionals are expected to attend Europe’s leading event for laboratory management and diagnosis.
With the European medical laboratory market expected to reach USD 15.5 billion (€ 14.2 billion) by 2024[1], a platform such as MEDLAB presents a huge opportunity for global laboratory industry leaders, including manufacturers, dealers and distributors, to make inroads into the European market. Housing international exhibitors and covering 2,000 sqm of exhibition space, MEDLAB Europe will give visitors from across the world an opportunity to access cutting-edge laboratory products, next-generation technology, innovative services and world-class educational content. 
According to Tom Coleman, Group Exhibition Director, MEDLAB Series: “The launch of MEDLAB Europe is in line with our global expansion strategy for our MEDLAB series of events. The increasing prevalence of chronic diseases, rising geriatric population coupled with the rising awareness towards early diagnosis, has positioned the European medical laboratory market as a critical market for manufacturers, services providers, and dealers and distributors from across the globe. MEDLAB Europe will generate substantial value for our customers and partners by driving further product innovation and deeper engagement in these specific markets.”

Over the three-day event, MEDLAB Europe will also offer a multi-disciplinary congress tackling current challenges and developments key to the European market, and leveraging the true potential of laboratory testing to dramatically improve patient outcomes across the continent.

The conference programme covers five main tracks including Point of Care Testing (POCT), Histopathology, Lab Management, Microbiology and Hematology. From new methods of effective lab management to the development of techniques in detecting diseases, the conferences will also review the expanding role of the laboratory medicine and discuss partnership between a clinician and a lab professional in providing delivery of care to every patient.
“The scientific programme at MEDLAB has been carefully designed in collaboration with some of the brightest minds in the medical laboratory industry in order to have a real impact on improving the health and wellbeing of patients across the region,” said Coleman.

¹ http://www.grandviewresearch.com/press-release/europe-in-vitro-diagnostics-ivd-market-analysis

www.medlabeurope.com

Royal Philips and LabPON, the first clinical laboratory to transition to 100% histopathology digital diagnosis, recently announced its plans to create a digital database of massive aggregated sets of annotated pathology images and big data utilizing Philips IntelliSite Pathology Solution. The database will provide pathologists with a wealth of clinical information for the development of image analytics algorithms for computational pathology and pathology education, while promoting research and discovery to develop new insights for disease assessment, including cancer.
Deep learning algorithms have the potential to improve the objectivity and efficiency in tumour tissue diagnosis. In recent years, ‘deep learning’ techniques for image analysis have quickly become the state of the art in computer vision and has surpassed human performance in a number of tasks. The challenge for executing deep learning techniques is having access to a database with sufficient high volume and high quality data from which to develop the algorithms. As one of the largest pathology laboratories in the Netherlands, LabPON will contribute its repository of approximately 300,000 whole slide images (WSI) they prospectively create each year to the database. This will contain de-identified datasets of annotated cases that are manually commented by the pathologist, and will comprise of a wide variety of tissue and disease types, as well as other pertinent diagnostic information to facilitate deep learning.
“Deep learning focuses on the development of advanced computer programs that automatically understand and digitally map tissue images in considerable detail: The more data available, the more refined the computer analysis will be.” Said Peter Hamilton, Group Leader Image Analytics at Philips Digital Pathology Solutions. “Together, LabPON and Philips have the competence and skills to realize this.”
During a time where the pathologist shortage is mounting and cancer caseloads are increasing, the accurate diagnosis and grading of cancer has become increasingly complex, placing significant pressures on pathology services. Technologies such as computational pathology, could help pathologists with tools to work in the most efficient way possible.
“The role of the pathologist remains important by making the definitive diagnosis, which has a high impact on the patient’s treatment. Software tools could help to relieve part of the pathologists’ work such as identifying tumour cells, counting mitotic cells or identifying perineural and vaso-invasive growth, as well as carrying out measurements in a more accurate and precise way,” said Alexi Baidoshvili, pathologist at LabPON. “This ultimately could help to improve the quality of diagnosis and make it more objective.”
Next to the development of computational algorithms for diagnostic use, Philips intends to make available the database to research institutions and other partners through its translational research platform. This could enable selected parties to interrogate and combine massive datasets with the goal to discover new insights that ultimately could be translated into new personalized treatment options for patients.
www.philips.com/digitalpathology

EUROIMMUN and Roche announced early April 2017 that they have entered into an option agreement under which Roche gains access to intellectual property in the field of Zika virus immunodiagnostics assigned to EUROIMMUN.
In January 2016, EUROIMMUN became the first company in the world to launch antibody tests that are capable of indicating both an acute Zika virus infection (usually from the fifth day after the onset of symptoms) and previous episodes of the illness. The EUROIMMUN Anti-Zika Virus ELISA is also the first commercial serological Zika test to receive CE (Europe) and ANVISA (Brazil) Mark registrations.
Infectious diseases represent a major cause of death worldwide. Every year, 1.45 million people die of viral hepatitis and in 2014, 1.2 million died of AIDS-related causes. After the 2014 Ebola outbreak, Zika is the latest virus to create significant public health concern. There is growing body of evidence that links the Zika virus to birth defects in fetuses and newborns, and neurological complications in adults. Public health officials and experts in the field consider these associations valid based on a number of epidemiological studies, modelling, and use of predefined criteria. Concern among public health bodies is high since there are currently no effective interventions to control vector mosquitoes.
In order to prepare for the growing health emergency, EUROIMMUN launched the Anti-Zika Virus ELISA (IgM or IgG), a fully automated, highly specific test with reduced cross-reactivity to other flaviviruses. The Anti-Zika Virus ELISA (IgM or IgG) is based on a highly specific, recombinant non-structural viral protein (NS1), which avoids the cross reactivity typically associated with serological tests based on whole virus antigens. Data from panels of well-characterised sera have confirmed that there is no cross reactivity with flaviviruses including dengue, West Nile, yellow fever, tick-borne encephalitis and Japanese encephalitis viruses. In studies on clinically and serologically characterised samples the IgM and IgG ELISAs showed nearly 100% specificity. Furthermore, the combination of IgM and IgG ELISAs provides highest sensitivity of 97%. Serological testing provides a much longer window for diagnosis compared to direct detection methods. This type of testing helps assess a recent infection even when ribonucleic acid (RNA) is no longer detectable – if, for example, the infection is resolved or has moved into the chronic phase. It is therefore critical that any serology assay be extremely specific to Zika to reduce cross-reaction with these other viruses, thus avoiding a potential false positive that could lead to erroneous interpretation of a patient’s immune status.
“Until now it has been virtually impossible to distinguish a Zika virus infection by antibody testing from infections with other flaviviruses like dengue or West Nile virus,” said Dr. Wolfgang Schlumberger, Vice Chairman of the EUROIMMUN’s Board. “Our test may be used by travellers to areas with Zika virus outbreaks to assess any health risks and to take appropriate precautions upon return, and cooperating with Roche will help us make it available to the broadest possible spectrum of patients.”
Learn more about the Anti-Zika Virus ELISA.

As more biomarker-based studies open, such testing will increase opportunities to match patients with clinical trials.
Nearly three-quarters of patients with advanced cancer could be referred to a potential targeted treatment based on the results of a comprehensive analysis of their tumour’s genetic landscape, a new analysis finds.
The study suggests the value of so-called next generation sequencing, a sophisticated method of evaluating the DNA and RNA of a tumour to help direct treatment.
In a report on the first 500 patients with advanced solid tumours to go through the University of Michigan Comprehensive Cancer Center’s sequencing program, 72 percent qualified for a clinical trial based on a genetic marker in their tumour.
Although not all of those patients were able to enroll in a trial based on other eligibility factors and trial location, the number who did enroll doubled from about 5 percent of patients in 2012 to 11 percent in 2016. Increased trial enrollment occurred as several major national biomarker-based studies opened.
“Availability of biomarker trials is crucial for being able to act on these results. Over time, we became better at matching patients to clinical trials as more of these basket trials opened,” says Erin Cobain, M.D., clinical lecturer of haematology/oncology at the University of Michigan Medical School.
As part of the sequencing program, patients with stage 4 cancer undergo a biopsy and provide a blood sample to test their normal DNA. Patients also receive genetic counselling.
Results of the sequencing are discussed by a team of oncologists, genetics specialists, pathologists, bioinformatics specialists and genetic counsellors, among others, at a precision medicine tumour board. This group discusses all results and assesses the feasibility of pursuing treatment options based on the genomic findings.
Genetic sequencing involves looking at all of the DNA and RNA expressed within a tumor. Scientists comb through this enormous amount of data to identify anomalies that may prove to be targets for existing approved or experimental therapies.
In addition, the program sequences patients’ normal genome. This means it’s able to identify hereditary genetic variations, or those inherited from a mother or father and potentially passed down to children.
Researchers found these hereditary variations in 11 percent of patients, none of which had been previously identified through family history.
“That was a major surprise — that 11 percent of patients had a genetic change that increases cancer risk is much higher than we would expect. This has significant impact not only on the patients, but also on their families, who may carry a genetic susceptibility to cancer,” Cobain says.
MI-ONCOSEQ requires a fresh biopsy, whereas many commercial sequencing tools can use frozen tissue samples. This ensures the U-M researchers can perform a more comprehensive analysis. Commercial tests analyse only about 350 genes while MI-ONCOSEQ’s more thorough analysis of both DNA and RNA covers at least 1,700 genes.
This means many anomalies were identified that would not have been found on panel-based tests. Because MI-ONCOSEQ is run as a research study, patients do not pay for sequencing.
Cobain cites an example of a patient with cholangiocarcinoma, a cancer of the bile duct. Sequencing revealed a novel gene fusion that would not have been identified through panel-based tests. The patient was able to enroll on a clinical trial targeting the gene fusion and had an excellent response to that therapy.
“This would not have been found by a commercial assay,” Cobain says. “Sequencing is beginning to have a real impact on treatment recommendations. It’s important to consider this testing early in the patient’s clinical course in order to improve our ability to act on the results and impact the patient’s course.”

Michigan University
labblog.uofmhealth.org/rounds/genetic-sequencing-can-influence-treatment-for-advanced-cancer