EH 6/2014

AllimagescourtesyofHistoIndex KUGEL medical GmbH & Co. KG Hermann-Köhl-Straße 2a DE-93049 Regensburg · Germany Phone +49 (0) 9 41/20 86 48-0 Fax +49 (0) 9 41/20 86 48-29 E-Mail info@kugel-medical.de MADE IN GERMANY WE CREATE SOLUTIONS FOR HISTO-PATHOLOGY LABS www.KUGEL-medical.de Join us at the Arab Health 2015 Za´abeel Hall · Booth Z3F19 Azg_European_Hospital_Magazine_103x133.indd 1 24.11.14 12:19 EUROPEAN HOSPITAL Vol 23 Issue 6/14 12 LABORATORY Santa’sWe are seeing great priority shifts in China’s funding for R&D and manufacturing expansion. Even the agency responsible for select- ing the recipients has changed, Jie Ren reports from the Beijing- based market analysis consultancy Whitney Research Inc. Under which tree will Santa Claus leave a gift? To develop Chinese manu- facturing capabilities the Ministry of Science and Technologies, since the mid-80s, has awarded grants from the National ‘863’ programme. In the past decade medical devices, and particu- larly in vitro diagnostics (IVD), gained very large grants for R&D and to expand production. Initially, products were mostly cop- ies of multinational automated chem- istry analysers and immunoassay analysers, with perhaps hundreds of domestic companies introducing auto- mated chemistry analysers – although not too competitive in the high-end large city hospitals; mostly they com- peted with other Chinese firms in second tier cities and lower class hospitals with few patients and sam- ples. They could not replace imports – despite huge expenditure. Asked why it was suddenly intro- ducing automated chemistry analys- ers, one firm replied that the market was hot for them. ‘It must be,’ it explained, ‘look at all the companies getting into it.’ China’s scientific mar- ket research is still not very scientific. Into which Christmas stocking will molecular fit? Molecular is a newly focused phe- nomenon. In China, PCR (Polymerase chain reaction) was first clinically introduced in the ’90s, but a lack of skilled labour and lax regulations brought many false positive results – primarily from contamination. The Ministry of Health banned the clinical use of PCR and, in 2002, released strict clinical PCR lab regulations: clinical PCR labs and technicians were to be Ministry of Health certified. As of April 2014, about 1,800 certified clinical PCR labs nationwide have reported clinical results – from multinational and Chinese equipment and reagents – reaching reasonable standards. Despite heavy regulations, lag time for CFDA and for the Ministry to mod- ernise alongside newer technologies, the still comparatively small molecular diagnostic market has experienced rapid growth. We expect well over 20% in the next several years, driven by healthcare reform, an aging popu- lation and improved test payment capabilities. China’s 12th five-year plan lists molecular diagnostics and compan- ion diagnostics as significant devel- opment projects, and will establish 30-50 clinical translational medicine centres nationwide, and build 30-40 bio-pharmaceutical development and industrialisation bases for antibody, vaccine and diagnostic reagents devel- opment, as well as cultivate 10 leading enterprises. Today, PCR-based diagnostic prod- ucts still dominate China’s molecular market, of which infectious disease tests, particularly HBV and HPV are primary products. Most domestic man- ufacturers focus on PCR tests using established technologies. HIV and HBV molecular tests are now required for blood screening. ELISA, widely used for these, showed lower sensitivity. Promoting a nucleic acid test for blood screening, the National Health and Family Planning Commission aims to have 100% nucle- ic acid tests in Beijing and Shanghai, Introducing stain-free 3-D digital pathology Gideon Ho, CEO and co-founder of Singapore-based HistoIndex is con- fident: ‘After a biopsy a patient waits in a hospital bed, but now, instead of waiting a couple days until doctors know how to treat this patient, we can deliver results while the patient is still in the hospital.’ This is because the firm has developed a laser-based, mul- tiphoton imaging system for tissue diagnosis that eliminates the time- consuming process of sample stain- ing. ‘It’s phenomenal,’ he added, ‘a paradigm change that will disrupt many things.’ For pathologists who use tradi- tional light microscopes, staining tissue samples is essential because it provides a contrast that can spotlight cellular features, such as tumours. Eliminating time and costs for staining slide samples alone could revolutionise lab analytics. However, like a smart phone, the compact desktop Genesis200 instru- ment from HistoIndex is loaded with capabilities that accelerate the workflow, enhance diagnostic qual- ity, and ultimately benefit patients. After loading a biological speci- men on the Genesis instrument the operation is fully automated from scanning to image processing and even analysis. The technology at the heart of the Genesis platform is two-pho- ton excitation fluorescence (TPEM) using a femtosecond laser that results in the emission of a photon that passes through a crystal and then a prism to generate a second- harmonic wave. The non-linear, dual-channel imaging technique results in a high- resolution image that maps tissue samples and enables fine measure- ments in three dimensions. This 3-D visualisation of bulk samples represents another revolu- tion for tissue diagnosis enabling an examination of morphology to a depth of 300 micrometres, features that are usually lost when samples are thinly sliced for microscope slide preparation. The digital capture also enables computerised assistance for quanti- fication, eliminating inter- and intra- Full commercialisation of the technology will come in 2015 with a new instrument, the Laennec, com- bined with the FibroIndex software and connecting to the Liver Cloud. The Laennec analyser is currently in the regulatory approval process ‘everywhere,’ said Ho. Follow-on products for the Genesis platform will see the intro- duction of multi-modular, mul- ti-organ imaging capabilities to expand the HistoIndex footprint in the lab for tissue analysis. ‘Who can remember how we worked without smart phones? Digital pathology is going to bring the same revolution to clinical diag- nosis with smart instruments and we are at the centre of what is going to happen,’ Gideon Ho said, with confidence. Gideon Ho gained his Master Degree in Engineering (M.Eng.) at the School of Mechanical and Production Engineering, Nanyang Technological University, in 2000. He finished his Doctorate in Philosophy (Ph.D.) in the Bioengineering Unit of the University of Strathclyde, Glasgow in 2004. His research topic was low-level laser therapy on tissue-engineered skin substitutes. In August 2010 he co-founded HistoIndex Pte. Ltd, of which he is CEO. His job scope includes commercial strategy, development of the company and aligning all functions of the company to meet its strategic commercial objectives. He also has a Certificate in Strategic Leadership of Technology and Innovation from Stanford University Graduate School of Business. Biopsy results while you wait Rat model fibrosis study, with images taken from Carbon tetrachloride (CCl4) and Bile Duct Ligation (BDL) using Multiphoton Microscopy. A) and B) are images obtained from Two Photon Excited Fluorescence (TPEF) together with Second Harmonic Generation (SHG) from CCl4 and BDL, respectively. C) and D) are the corresponding 3-D projections of 50-um-thick tissue samples in the SHG channel only. We can clearly observe the differences between these two models. In the CCl4 model, collagen fibers (green) aggregated around vessel walls as liver fibrosis progressed, whereas fine collagen fibers distributed in sinusoidal areas disappeared. In the BDL model, collagen fibers aggregation took place around vessel walls, as well as in areas where bile ducts proliferated. Hepatocytes (red) are shown in the TPEF channel Visible morphological features of rat skin cross section. We can observe normal rat skin – with no disease and clearly distinguish dermis, adipose tissue, connective tissue, skeletal muscle, and follicles, together with the collagen content Effective application of Genesis200 Imaging system based on Two Photon Excited Fluorescence (TPEF) and Second Harmonic Generation (SHG) in the study of Cervical Intraepithelial Neoplasia (CIN) in mice. The two-layered structures of cervical tissue from the mice enable us to visualise the two-layered cervical microstructures, monitoring the metabolic activity and the density of epithelial cells as well as giving the ability to measure the epithelial cell nuclei size, together with the thickness of the epithelial layer and quantifying collagen in the stroma Grading of human breast cancer biopsy tissue samples based on Second Harmonic Generation (SHG) and Two Photon Excited Fluorescence (TPEF) with visible discrimination of the different collagen types (in blue & green) (Results obtained with a new Polarisation feature of Genesis200) CE Marked Genesis200 Imaging system from HistoIndex observer inconsistency. Uploading data sets to the cloud brings the full power of the digital revolution to tissue diagnostics cre- ating the possibility to share and compare results. ‘Everything goes up to the cloud and connecting, bringing us closer to integrated diagnostics, the poten- tial for combining test results for a fuller -omic view of the patient – using proteomics, in our case, with next-generation genomic sequenc- ing,’ said Ho. The Genesis200 is approved for commercialisation with a CE mark, though the strategic focus is on research centres rather than high- throughput labs. Images:HistoIndex Phone +49 (0) 941/208648-0 Fax +49 (0) 941/208648-29 Azg_European_Hospital_Magazine_103x133.indd 124.11.1412:19

EH 6/2014

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