Cause of resistance to breakthrough breast and ovarian cancer drug

Scientists have identified a mutation that gives cancer cells resistance to the breakthrough cancer treatment olaparib and other PARP inhibitors.
The study findings could help predict which patients will develop resistance to PARP inhibitors and allow doctors to alter treatment at the earliest possible opportunity.
A team at The Institute of Cancer Research, London, used gene editing to identify a specific mutation in the PARP1 protein that prevents PARP inhibitors from working.
Testing for this mutation could add another level of personalisation to an already targeted treatment – helping guide decisions about whether to use PARP inhibitors in the first place, and when to switch to other drugs, such as platinum-based therapies.
PARP1 is crucial for the repair of damaged DNA and is an important target for olaparib and other PARP inhibitors. These drugs are especially effective in patients who already have weaknesses in DNA repair because of inherited errors in the BRCA genes – a discovery that was made at the ICR.
The scientists used new ‘CRIPSR-Cas9’ gene editing technology to generate mutations in small, targeted sections of the PARP1 gene, and tagged the mutant protein with a fluorescent protein so their effects could be tracked.
This approach allowed the researchers to observe the effect of specific mutations on PARP1 and on the sensitivity of cancer cells to PARP inhibitors, such as olaparib and talazoparib.
Olaparib is available on the NHS for women with ovarian cancer who have inherited BRCA mutations, and is currently being evaluated for breast cancer. It was the first ever cancer drug to be approved that is targeted against an inherited genetic fault.
The study identified specific PARP1 mutations which disrupt the ability of the protein to bind to DNA, which means PARP inhibitors can no longer trap them at the site of DNA damage.
The researchers found that, contrary to their original predictions, cancer cells with certain mutations in the BRCA1 gene could survive this loss of PARP1’s DNA repair function – making them resistant to PARP inhibitors.
It is thought that in these cases the BRCA1 gene retains some function, providing some residual ability to repair DNA despite the loss of PARP1.
The scientists emphasised that further research needs to be carried out to examine more PARP1 mutations in patients as only one example in humans was found in this study.
The team is looking to apply this same gene editing approach to study how resistance arises to other drugs, and if it is possible to predict how quickly this resistance will progress.

Institute of Cancer Researchwww.icr.ac.uk/news-archive/scientists-identify-cause-of-resistance-to-breakthrough-breast-and-ovarian-cancer-drug

DIAsource Immunoassays to assume production and sales of ZenTech RIA product portfolio

ZenTech has signed a strategic agreement to transfer its portfolio of radioimmunoassays (RIA) to DIAsource ImmunoAssays, a BioVendor group company.
ZenTech, a Belgian biotech company specialized in the development, production and commercialization of solutions for clinical diagnostics of early life stage diseases and newborn screening, and DIAsource ImmunoAssays, a leading diagnostics company delivering manual RIA and ELISA kits and open automation solutions to international markets, today announced a strategic agreement, under which ZenTech will transfer its portfolio of RIA products to DIAsource, securing the continued production and sales of these products.

ZenTech has strategically reoriented itself to focus on newborn screening and early life stage diseases. DIAsource is the second largest supplier of radioimmunoassays in the world, committed to servicing customers worldwide that use manual ELISA and RIA assays and open automation to complement their portfolio on closed automated systems.

Both Belgian companies have long standing collaborations for more than 15 years, whereby DIAsource already managed part of the commercialization of the Zentech portfolio successfully. The current transfer of the RIA products from Zentech to DIAsource is a logical next step in line with the strategies of both companies. The portfolio to be transferred includes the complete line of specialty radioimmunoassays with thyroid markers and markers for fertility and salt balance.

In order to support a smooth transition with minimal disruption for customers, the companies have agreed to a transition period. Effective today 24th of July 2018 DIAsource Immunoassays assumes commercial ownership of the RIA product portfolio and will service clients from order to shipment, whereby ZenTech remains the manufacturer during the transition period in which the production will be transferred to DIAsource. The latter will be done in close collaboration and in phases and concluded by 30 September 2019.

Jean-Claude Havaux, Chaiman of the Board, ZenTech, said: “Historically, ZenTech had a background and expertise in radioimmunoassays. However, when ZenTech acquired the Belgian company Gamma in 2011, it got access to new technologies and entered the market of newborn screening and early life stage diseases. Today’s acquisition of the RIA products by ZenTech’s commercial partner DIAsource will guarantee RIA customers are offered long term service and excellence in logistics worldwide. This transaction will give ZenTech the opportunity to focus on new innovative product lines and other technologies such as molecular diagnostics and mass spectrometry. ZenTech strives to "make innovation affordable for most" within a worldwide strategy.”

Jef Vangenechten, CEO of DIAsource Immunoassays, said: "This acquisition is yet another step in our strategy to position DIAsource as a consolidator of manual specialty assays, after previous acquisitions of the Intertech RIA product line in 2012 and Viro-Immun ELISA and IFA product lines in 2017. DIAsource also acquired the RIA client businesses from distribution partners in France and Spain in 2015 and 2016. This fourth acquisition in the RIA space demonstrates our commitment to the long term future servicing and support of our large RIA customer base worldwide
We experience that RIA remains important as the gold standard for assays that are not available on automated systems or for parameters that require a higher analytical accuracy, whereby manual assays offer benefits in terms of quality and flexibility versus price.
DIAsource now has a unique position by combining the most complete offering of RIA specialty assays on the market with the ability to offer various RIA automation solutions. Furthermore our manual assays also allow customization for life science research and screening."

www.diasource-diagnostics.comwww.zentech.be

Top Trends Changing The Medical Laboratory Industry In Europe

The way healthcare is delivered around the globe is changing. Patients are now at the centre of how medical care is delivered and recent advances in medical technology have allowed medical laboratory testing to move in parallel with this course.
Keeping up-to-date with latest industry trends emerging from within the medical laboratory industry is critical to the lab professional, particularly in Europe, where the In-Vitro Diagnostics (IVD), clinical laboratory, molecular diagnostics and Point-of-Care Testing markets are some of the fastest growing in the world.
Regulations around medical and IVD devices in Europe are also evolving which involves important improvements to modernise the current system including risk-classification, improved transparency and new rules on clinical evidence. Under these new regulations, the classification of devices is based on risk and manufacturers need to demonstrate that their medical device meets the requirements by carrying out a conformity assessment.
Essentially, the European medical laboratory-testing ecosystem is becoming safer, faster and more efficient, and technology and regulations are evolving to put patient safety and care at the heart of healthcare delivery. Here are some of the top trends that are shaping the European medical laboratory industry in 2018:
Point-of-Care Testing (POC)
As the world becomes more connected, POC testing enters a rapid phase of development. Medical decisions can be made quickly as the disease can be diagnosed at an earlier stage. Next generation POC testing is entering the market with prospective label-free biosensors, such as electrochemical, surface plasmon resonance (SPR), white light reflectance spectroscopy (WLRS), etc., being used for improved devices. Also, a wide range of POC assays for the quantitative determination of biomarkers has been developed using portable and easy-to-use POC clinical and biochemical analysers. 3D printing also shows huge potential to improving the performance of POC devices.
The Internet of Things (IoT)
The IoT can help to reduce the rising costs in laboratory testing while also increasing access to patient care. According to a report by ABI Research, connectivity to lab equipment and the services enabled by that connectivity will increase total global laboratory test throughput to over 3.02 billion more diagnostic tests by 2020.
Laboratory Automation
Increasing the efficiency to maximise the productivity and manage costs has become critical for the long-term success of the clinical laboratory. Robotic automation is an area where patient-focused technology can make a real difference. The future lies in automated phlebotomy, transportation processes using drones and Artificial Intelligence (AI) with these advancements providing increased access to healthcare.
Next-generation DNA sequencing (NGS)
Since the introduction of many next-generation sequencing (NGS), the cost of DNA sequencing has significantly reduced and huge improvements have been made in the unraveling the complexities of sequencing data. In situ sequencing (ISS) offers incredible new opportunities for studying tissue heterogeneity, for example. NGS provides cheaper, friendlier, and more flexible high-throughput sequencing options with a quantum leap towards the generation of much more data on genomics, transcriptomics, and methylomics that translate more productively into proteomics, metabolomics, and systeomics.

www.medlabeurope.com

FDA grants Breakthrough Device Designation for Roche’s Elecsys cerebrospinal fluid (CSF) assays to support diagnosis of Alzheimer’s disease

Roche announced in July that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Elecsys® ß-Amyloid (1-42) CSF and Elecsys® Phospho-Tau (181P) CSF. These in vitro diagnostic immunoassays are for the measurement of the ß-Amyloid (1-42) and Phospho-Tau concentrations in cerebrospinal fluid (CSF) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) or other causes of dementia.
Currently, the diagnosis of AD is largely based on clinical symptoms, including cognitive testing, with a significant number of patients diagnosed when their disease has already advanced. A diagnosis of AD based on cognitive measures alone is only correct in 70 – 80 percent of cases. Measuring biomarkers with CSF immunoassays, associated with AD pathology, increases certainty of a diagnosis of AD and can help to evaluate the progression of the disease. The Breakthrough Device Designations are for indication of use with Elecsys β-Amyloid (1-42) CSF and Elecsys Phospho-Tau (181P) CSF in concordance with amyloid PET visual read result and risk of cognitive or functional decline. The Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. This program is designed to expedite the development and review of these medical devices.
“We are excited about FDA’s recognition of the potential clinical benefit the Elecsys CSF assays can bring to clinicians, laboratories and their patients in diagnosing AD at an early stage,” said Roland Diggelmann, CEO of Roche Diagnostics. “Roche was one of the first companies to use biomarkers in clinical trials and we will continue to explore high-performing diagnostic and disease-monitoring solutions.”

www.roche.com

QIAGEN’s careHPV™ Test wins WHO prequalification status for cervical cancer screening

QIAGEN announced on August 1st that its careHPV™ Test, one of the only molecular diagnostics for high-risk human papillomavirus (HPV) designed to screen women in low-resource settings, has been added to the World Health Organization (WHO) list of prequalified in vitro diagnostics (IVDs). HPV is the primary cause of cervical cancer, so screening women for the presence of the virus is a critical aspect for prevention and early treatment of the deadly cancer. The careHPV Test was launched globally in 2010 and through numerous pilot studies has demonstrated to be a more sensitive alternative to cytology and visual inspection based methods for the detection of pre-cancerous cell abnormalities. The WHO’s evidence-based listing is expected to expand the availability of this critical diagnostic tool in countries that rely on the global organization’s list in making purchasing decisions. The WHO Prequalification status will significantly broaden access to HPV DNA testing to areas of the world with a high burden of cervical cancer.
 
“The WHO prequalified IVD listing is a ‘stamp of approval’ for our innovative careHPV Test, and this will encourage authorities to adopt efficient, highly accurate HPV screening for prevention of cervical cancer in settings with limited healthcare infrastructure,” said Thierry Bernard, Senior Vice President, Molecular Diagnostics Business Area, for QIAGEN. “China routinely uses careHPV in rural or low-resource areas, and QIAGEN partners with non-governmental organizations and health ministries in developing countries. We expect the WHO listing to drive further dissemination of this important tool for women’s health.”
 
QIAGEN’s fast, portable and easy-to-use careHPV Test combines the power of advanced molecular technologies with innovative design features for areas lacking consistent electricity, water or a controlled laboratory environment. For example, the system has color-coded, easy-to-understand menus and self-contained reagents. The test tolerates temperature variations that occur in rural clinics lacking refrigeration due to limited electricity or water, and can provide results much faster than traditional laboratory based methodologies. The careHPV Test was developed with support from PATH, an international nonprofit organization, and is manufactured by QIAGEN in Shenzhen, China.
 
“High-quality molecular HPV tests that are easy to run are critical for expansion of cervical cancer prevention strategies in low-resource settings. WHO prequalification of careHPV is excellent news that will help countries to choose the best and most suitable technology for their programs. To achieve higher coverage of at-risk women and make an impact in cervical cancer prevention, we need to move to affordable and cost-effective strategies with HPV testing leveraging self-sampling potentially,” said Dr. Silvia de Sanjosé, Director of Scale-Up project at PATH, a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges.
 
The careHPV Test for low-resource settings is highly complementary with QIAGEN’s digene HC2 HPV Test, the world’s most validated and sensitive diagnostic test for detection of high-risk HPV. The digene HC2 HPV Test is recognized as the “gold standard” in HPV screening and is widely used in developed countries and in large cities in emerging markets.
 
Cervical cancer is the fourth most common cancer among women worldwide, with an estimated 528,000 new cases and 266,000 deaths in 2012, the most recent year for which WHO publishes statistics. An estimated 80% of new cases and deaths occur in developing countries, where awareness of the disease and access to preventive tests and medical treatment is low. In many low-resource areas, cervical cancer has eclipsed breast cancer as the primary cancer killer of women.

http://www.qiagen.com

New Clues about the Blood-Clotting Ability of Leeches

Leeches are blood-feeding organisms that have a suite of anticoagulant compounds they secrete from their salivary glands that prevent blood clotting. This allows them to maximize feeding time and blood volume. Leeches are still used in modern medicine, and knowledge about their anticoagulants is important in many ways, from rodent control to understanding host-parasite relationships. A recent study expands our knowledge about the diversity of anticoagulants in two families of leeches.
The authors of an article recently published in the Journal of Parasitology collected leeches from natural and aquarium settings in the United States and Canada. The researchers examined the physical characteristics of each leech to determine their species, dissected the leech salivary glands, extracted the RNA and sequenced the genomic material. Next, they identified the salivary gland components by comparing their sequences with those of other leeches and various animals.
The researchers identified the collected leeches as nine species from the Piscicolidae and Ozobranchidae families, which are composed of saltwater species that feed on fish and turtles, respectively. Despite the fact that these leeches have different host preferences, no differences were found in the diversity of anticoagulants. There was an average of 43 anticoagulants in each species, and the researchers identified several anticoagulants that didn’t match any sequences and others that had never before been linked to leeches. For example, they found sequences that matched ohanin, which is a protein found in king cobra venom. These results suggest that there is a possible connection between anticoagulants in leeches and snake venom and should be explored further.
Michael Tessler, one of the authors of this article, points out why this study is unique among the literature on anticoagulants: “What I believe makes this paper stand out is the broad scope. Our results highlight that looking at individual species is not a great proxy for family-level anticoagulant diversity and that studies need to take a broader look to fully understand what is going on.” Sampling many species and comparing sequences to a broad array of organisms, therefore, could help uncover new information.
The authors also constructed phylogenetic trees, diagrams that show evolutionary relationships, and concluded that leeches may have evolved to have anticoagulants that are beneficial to them. These new leech anticoagulant sequences not only aid in our understanding of the diversity of these compounds, but also provide clues about how leech evolution plays a role in the host-parasite relationship.
http://www.journalofparasitology.org/doi/full/10.1645/17-64

Shimadzu’s investments and commitment for developing new analytical and medical technologies for tomorrow

In the year of its 50th anniversary in Europe, Shimadzu has been awarded the NRW.INVEST Award 2018 for outstanding investments and commitment to the location. This prestigious award is presented by North Rhine-Westphalia (NRW), Germany’s industrial heartland and most populated federal state. Andreas Pinkwart, Minister of Economics and Digitalization, presented the award in Düsseldorf at the end of June. Founded in 1968 with five employees, Shimadzu today supervises more than 700 employees across Europe from its European headquarters in Duisburg. The city is also home to Shimadzu’s European Innovation Center, a think tank that combines academic and scientific know-how from universities with Shimadzu’s high-quality analytical technologies to design new solutions for tomorrow. "Merging analytical and medical technology methods breaks new grounds in diagnosis and treatment, especially of endocrine disorders, cancer and dementia," says Jürgen Kwass, Managing Director Shimadzu Europe. "These include, for example, chromatography/mass spectrometry combined with angiography or near-infrared photoimmunotherapy."

www.shimadzu.eu

UCI, Beckman Coulter Diagnostics announce strategic collaboration

Beckman Coulter Diagnostics has embarked on a strategic collaboration with the University of California, Irvine – one of the first targeted academic partnerships the company envisions around the globe.
Beckman Coulter Diagnostics will access UCI research in innovative diagnostic platforms, life sciences applications, devices, and data analytics to further its mission of advancing healthcare. UCI faculty, students and entrepreneurs will benefit from Beckman Coulter Diagnostics’ expertise in accelerating the commercialization of technology and other world-class UCI breakthroughs.
“We are honoured that Beckman Coulter Diagnostics has selected UCI as a strategic innovation partner,” said Richard Sudek, Ph.D., chief innovation officer and executive director at UCI Applied Innovation. “This is a new type of industry collaboration which aims to significantly change how industry and universities partner together. We look forward to teaming up with Beckman Coulter to increase the speed and quality of how UCI discoveries make it to market.”
“We are excited to tap into the broad expertise of UCI researchers as we focus on identifying innovative solutions to clinical unmet needs“ said Fiona Adair, Ph.D., vice president of strategy and innovation at Beckman Coulter Diagnostics. “We believe this type of academic-industry partnership can lead to development of innovative diagnostic technologies to improve healthcare. UCI Applied Innovation is a place where valuable new ideas are incubated. In turn, we can provide promising students, researchers, and entrepreneurs industry-specific feedback and mentorship opportunities. We will have a Beckman Coulter office at the Cove @ UCI Applied Innovation for seamless collaboration with academic units as well as to integrate into the innovation ecosystem.”
This level of collaboration is an industry model of synthesizing research, commercial expertise and clinical needs to produce beneficial results. As a first step, Beckman Coulter will fund Proof of Product grants to help UCI innovations bridge the gap between the lab and early commercialization. Through these grants, Beckman Coulter will determine a specific focus area for university entrepreneurial teams.  
Additionally, Beckman Coulter will also seek eligible UCI graduate students to enter its competitive talent onboarding program, in which they’ll get the opportunity to work across multiple divisions of the company.  
“The partnership with UCI represents a landmark in Beckman Coulter’s strategic initiatives to drive translational innovation and extend the company’s leadership in clinical diagnostics.” said John Blackwood, senior vice president and general manager of products and services at Beckman Coulter. “Beckman Coulter is engaging with academic partners that excel in applying the latest technology to develop superior solutions for better patient outcomes. UCI maintains an ecosystem of innovation that facilitates academic-industry partnerships and we are excited about the opportunity to leverage UCI’s research expertise for the benefit of patients around the world.”  

www.uci.edu   www.beckman.com

Diasource ImmunoAssays and Svar Life Science (formerly Euro Diagnostica) sign milestone agreement

In late July, Svar Life Science signed a strategic agreement to transfer the portfolio of radioimmunoassays (RIA) and the Chromogranin A Neolisa™ (ELISA) product to DIAsource ImmunoAssays, a BioVendor group company.
Svar Life Science AB (formerly Euro Diagnostica AB), a Swedish life science company that has been working across the clinical diagnostic value chain for over 30 years, and DIAsource ImmunoAssays, a leading diagnostics company delivering manual RIA and ELISA kits and open automation solutions to international markets, today announced a strategic agreement, under which Svar Life Science will transfer its portfolio of RIA products and the Neolisa™ CgA ELISA product to DIAsource, securing the continued production and sales of these products.
Svar Life Science will continue to invent, develop and apply the best analytical technologies, with a focus on helping deliver the answers needed in drug discovery and clinical diagnostics, and the impact this has on human lives.
This transaction strengthens DIAsource and BioVendor’s position as one of the top RIA and larger ELISA manufacturers, committed to servicing customers worldwide that use manual assays and open automation to complement their portfolio on closed automated systems.
The portfolio to be transferred includes the complete line of radioimmunoassays for the quantification of a number of peptide hormones involved in critical physiological processes. These endocrinological parameters are mainly used as tumour markers and for diabetology and salt balance analysis. The portfolio transfer also includes the ELISA Chromogranin A Neolisa™ product which complements the RIA Chromogranin A product.
In order to support a smooth transition with minimal disruption for customers, the companies have agreed to a transition period. Starting 1st of September 2018 DIAsource ImmunoAssays assumes sales of the RIA product portfolio. During the remainder of 2018 the RIA production will be transferred. Sales of the Neolisa™ CgA ELISA product will be assumed by DIAsource as of January 2019, with production transfer to follow during 2019.
Ron Long, CEO, Svar Life Science, said: “The agreement with DIAsource ImmunoAssays forms part of our strategy of focusing our product portfolio and core technologies to help deliver the answers needed in drug discovery and clinical diagnostics today. It also enables us to strengthen our support for life science customers providing high quality solutions, the best analytical technologies for drug development and clinical research.
DIAsource ImmunoAssays are committed to being a complete diagnostic provider and we’re confident that this agreement enables them to increase their support for customers in the field of radioimmunoassays.”  
Jef Vangenechten, CEO of DIAsource ImmunoAssays, said: “This acquisition is another step in our strategy to position DIAsource as a consolidator of manual specialty assays, after previous acquisitions of the Intertech RIA product line in 2012, Viro-Immun ELISA and IFA product lines in 2017, and more recently the RIA product line from ZenTech.”www.diasource-diagnostics.com

Genomic Medicine, Cambridge, 2018 (Meeting preview)

The 2018 Biotexcel conference ‘Genomic Medicine’ will take place at Murray Edwards College, Cambridge, UK, on 5–6 December 2018.

The running scientific theme for this meeting, like other Biotexcel genomic meetings, will cover the areas where Next Generation Sequencing is used in the analysis of human disease.  These topics will  include different disease areas where particularly promising genomic studies have been performed; large population studies; whole genome & whole exome studies; epigenomics and many other topics. In this meeting we will also hear from commercial genomic companies, whether those that currently have genomic solutions on the market as well as those that are spin-outs or are in the research/earlier phases.

Confirmed speakers include (among others):

  • Prof. Lucy Raymond, University of Cambridge
  • Dr Caroline Wright, University of Exeter Medical School
  • Dr Anna Middleton, Wellcome Sanger Institute
  • Dr Nitzan Rosenfeld, Cancer Research UK Cambridge Institute
  • Prof Ferenc Mueller, University of Birmingham
  • Prof Yanick Crow, MRC IGMM, University of Edinburgh
  • Prof Michael Parker, University of Oxford
  • Dr Athena Matakidou, Astra Zeneca.

Topics to be covered include:

  • Whole genome sequence analysis of critically ill children
  • Transforming drug discovery and development with an integrated genomics approach
  • Making new genetic diagnoses with old data
  • How is society responding to genomics?
  • Genomic analysis of cell-free DNA in plasma for non-invasive cancer diagnostics
  • Genomic imprinting: lessons on the 4D genome.

The meeting will also have presentations on a variety of the latest technology developments.

In addition to presentations, the meeting will also include a number of networking opportunities, such as an introductory networking session on Day 1, a panel debate on topical issues and bottlenecks, a poster session and a networking dinner at The Punter Pub.

This meeting is intended to be suitable for NGS users, researchers and students, bioinformaticians and those in the NHS and private labs, biotech companies, CROs and service providers.

Discounts are available for students, academics and hospital staff. https://biotexcel.com/event/genomic-medicine-2018-cambridge