Applied Spectral Imaging Receives South Korean Ministry of Food and Drug Safety (MFDS) Clearance for GenASIs™ HiPath IHC Family for HER2, ER, PR and Ki67

Thursday, April 16, 2015

Clearance enables offering ASI advanced image capture and analysis platform to the South Korean hospitals and laboratories.

Carlsbad, CA – April 16, 2015 – Applied Spectral Imaging (ASI) announced today that it has received clearance from the South Korean Ministry of Food and Drug Safety (MFDS) for its GenASIs HiPath image capture and analysis platform. The South Korean market is a key market for ASI’s computer-aided imaging solutions for pathology, which help improve patient care.

“We are looking forward to leveraging this important clearance to offer our advanced image capture and analysis platform to the Korean population”, said Limor Shiposh, ASI’s Chief Executive Officer.

ASI’s GenASIs HiPath IHC Family is an advanced image analysis platform for IHC samples that integrates with existing lab microscopes and workflows, providing labs with a cost-effective solution for digital pathology. The platform is intended for use as an aid to pathologists in the semi-quantitative analysis and scoring of HER2, and qualitative analysis and scoring of Estrogen Receptor (ER) (SP1), Progesterone Receptor (PR) and Ki67 (30-9) proteins in formalin-fixed, paraffin-embedded breast cancer tissue.

“The South Korean market is a rapidly-growing market, and with the GenASIs HiPath, pathologists in South Korean’s hospitals and laboratories will now be able to use their own microscope and capture the relevant tumor regions with just one click, receiving immediate scoring and statistical analysis of the selected region of interest,” said Limor Shiposh, ASI’s Chief Executive Officer. “This clearance is the result of months of work and it is a valuable addition to our worldwide clearances portfolio for computerized clinical diagnostic aids covering both brightfield IHC and FISH probes”, Mrs. Shiposh added.

“The GenASIs HiPath is a superior diagnostic tool which assists pathologists with their analysis”, said Mr. Moo Yeol Yoon, President of SeongKohn Traders’ Corp., ASI’s distributor for the GenASIs HiPath in South Korea. “We are confident that the Korean market will be eager to take advantage of this advanced imaging option and we are excited to facilitate that process. The ASI GenASIs HiPath provides an unprecedented diagnostic practice for the local pathologists, which will advance patient care and assist our customers in improving workflow and achieving more accurate clinical results, efficiently and cost effectively.”

About ASI

ASI is a global leader in the development of imaging solutions for pathology, cytogenetic, and life science research.

The GenASIs automated imaging platforms for pathology and genetic analysis provide advanced diagnostic aids for pathologists and cytogeneticists, with reproducible and reliable results. GenASIs platform can be used with any brand of brightfield or fluorescence microscope, and supports manual and automatic scanning for a wide range of workflows and applications, to best suit the needs, size and budget of any lab.

The GenASIs platform is FDA cleared for BandView Karyotyping, FISHView, SpotScan for CEP XY, UroVysion, ALK and HER2/neu FISH, and HiPath for IHC Family: HER2, ER, PR and Ki67.

ASI serves clinical laboratories, life science companies and research institutions in over 50 countries, through direct sales and service personnel and its extensive worldwide distribution partners.

 

About SeongKohn Traders’ Corp.

SKT is specialized in the import and distribution of Histo/Cytopathology lab instruments, reagents, and consumables representing global pathology companies.

During the last 27 years, the company has contributed to the automation of the sample preparation and the introduction of liquid-based cytology and the renovation of autopsy suites in the local market.

SKT is also contributing to the facilitation of digital pathology solutions in addition to the conventional diagnostic practice and provides ‘digital slide web hosting service’ for the regular proficiency tests and slide conferences for the Korean Society of Pathologists (KSP) and the Korean Society for Cytopatholgists (KSC) and their sub-study groups and regional meetings, as well as other toxicology, dental, veterinary organizations.  www.digitalpathology.co.kr

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For More Information Please Contact –

Applied Spectral Imaging 

Phone: +1(800) 611-3466

E-mail: Sales@spectral-imaging.com

www.spectral-imaging.com 

 

SeongKohn Traders’ Corp.

Tel:  +82 2 540 3311

Fax: +82 2 540 6333

E-mail: myyoon@seongkohn.co.kr

Website: www.seongkohn.co.kr

www.digitalpathology.co.kr 

Applied Spectral Imaging receives FDA Clearance for GenASIs™ HiPath IHC Family for HER2, ER, PR and Ki67

Valuable addition to extensive ASI portfolio of FDA-cleared clinical diagnostic aids for both brightfield IHC and FISH probes. 

Carlsbad, CA. – January 21, 2015 – Applied Spectral Imaging (ASI, www.spectral-imaging.com) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for its GenASIs HiPath image capture and analysis platform.

ASI’s GenASIs HiPath IHC Family is an advanced image analysis platform for IHC samples that integrates with existing lab microscopes and workflows, providing labs with a cost-effective solution for digital pathology. The platform is intended for use as an aid to pathologists in the quantitative analysis and scoring of HER2, Estrogen Receptor (ER) (SP1), Progesterone Receptor (PR) and Ki67 (30-9) proteins in formalin-fixed, paraffin-embedded breast cancer tissue.

“The FDA clearance represents ASI’s commitment in offering superior diagnostics tools to assist pathologists with their quantitative analysis. With the GenASIs HiPath, ASI is proud to offer pathologists an important, easy to use solution to improve workflow and obtain reliable clinical results. It is a valuable addition to our extensive portfolio of FDA-cleared computerized clinical diagnostic aids covering both brightfield IHC and FISH probes. Pathologists can now capture with one click the relevant tumor regions, using their own microscope and receive immediate scoring and statistical analysis of the selected region of interest,” said Limor Shiposh, CEO of ASI.

“Our GenASIs solutions and robust portfolio of FDA cleared applications assist our customers in improving workflow and achieving more accurate clinical results, more efficiently and cost effectively.”

About ASI

ASI is a global leader in the development of imaging solutions for pathology, cytogenetic, and life science research.

The GenASIs automated imaging platforms for pathology and genetic analysis provide advanced diagnostic aids for pathologists and cytogeneticists, with reproducible and reliable results. GenASIs platform can be used with any brand of brightfield or fluorescence microscope, and supports manual and automatic scanning for a wide range of workflows and applications, to best suit the needs, size and budget of any lab.

The GenASIs platform is FDA cleared for BandView Karyotyping, FISHView, SpotScan for CEP XY, UroVysion, ALK and HER2/neu FISH, and HiPath for IHC Family: HER2, ER, PR and Ki67.

ASI serves clinical laboratories, life science companies and research institutions in over 50 countries, through direct sales and service personnel and its extensive worldwide distribution partners.

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For More Information Please Contact –

Applied Spectral Imaging

Phone: +1(800) 611-3466

E-mail: Sales@spectral-imaging.com

www.spectral-imaging.com

Applied Spectral Imaging and Biocare Medical Partner to Deliver Comprehensive Solutions for Immunohistochemistry

A partnership making R2R workflow (“Reagent to Report”) a reality by combining Biocare’s automated IHC instrumentation and reagents with ASI’s computer-aided imaging and analysis 

Carlsbad, California and Concord, California, December 4, 2013 – Applied Spectral Imaging Inc. (ASI) and Biocare Medical, LLC (Biocare) announced today the signing of a strategic partnership agreement in which Biocare will distribute ASI’s IHC and CISH imaging and analysis solution, GenASIs Pathology, in the United States. The agreement brings to cytopathology and anatomic pathology laboratories a fully integrated solution that improves quality while providing compelling work-flow efficiencies.

Biocare Medical is an innovator in the growing field of automated instrumentation for IHC and ISH. ASI is a leader in multi-modality, microscopy imaging and analysis, offering a suite of automated and semi-automated computer-aided analysis and scoring aids for IHC, CISH, FISH and karyotyping. A combined, end-to-end, automated solution for IHC brings exceptional value, enhanced efficiency and superior clinical results to laboratories which are experiencing a surge in the number of IHC tests performed.

From slide preparation through analysis, all the way to result reporting, the combined solution enables faster turn-around time while providing accurate, reproducible and standardized results. Laboratories benefit from computer aided scoring, counting and ratio analysis, providing Allred, H-score and M-score analysis automation. The system provides standardized results for stains such as ER, PR and HER-2 (cErbB2). Analysis results and automatically generated reports are managed in the solution’s built-in information management system, which may be linked to a Laboratory Information System (LIS).

“Our team is very excited to partner with Biocare. Both companies have worked hard to ensure our customers benefit from unparalleled value in IHC automation, imaging and analysis. The unique value we offer together extends from sample preparation all the way to case sign-out.” said Limor Shiposh, CEO of Applied Spectral Imaging Inc. “Our offering enables pathologists to focus on clinical analysis and investigation, offering accurate, documented and relevant results. The agreement between our two companies provides pathology labs with a complete end-to-end automated and documentation solution.” added Ms. Shiposh.

“I’ve tested quite a few imaging systems for scoring slides and the GenASIs Pathology outperformed all the rest. The biggest benefit of the system is how user-friendly and intuitive the software is, with no extensive training needed. You can sit down and get right to work in minutes,” said Joe Vargas, Director of Research and Development at Biocare Medical.

ASI and Biocare have tested and confirmed the combined solution’s effectiveness in performing end-to-end IHC and CISH, imaging, analysis and reporting.

About Applied Spectral Imaging

Applied Spectral Imaging (ASI) makes patient care better through advanced biomedical imaging.

ASI has been one of the industry’s leading microscopy imaging solution providers since 1993, with over 30 registered patents in the US, Europe and Japan and over 2,500 systems deployed worldwide. With worldwide offices in the US, Europe and Asia, ASI has built a global network of over 50 distributors.

GenASIs Pathology (IHC and CISH imaging and analysis solution)  is not intended for diagnostic or therapeutic use, for research use only.

For more information, please visit www.spectral-imaging.com

About Biocare Medical

Biocare Medical LLC is an innovator in developing and supplying world class automated immunohistochemistry (IHC) instrumentation, and the full range of reagents for IHC lab testing. Biocare is the market leader in simultaneous Multiplex IHC and antibody development, which solves difficult clinical problems and accelerates turnaround time. The company’s customers include clinical histology laboratories, pharmaceutical companies, CROs, and biotechnology companies as well as academic, government, military, and other non-profit laboratories. Biocare Medical offers an expanding portfolio of integrated products to address the rapidly growing cancer and infectious disease diagnostic and research markets using tissue immunostaining and in situ hybridization methods. Biocare Medical is headquartered and has manufacturing facilities in Concord, California, and has a global distribution network.

For more information, please visit www.biocare.net.

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Applied Spectral Imaging Inc.

Mrs. Limor Shiposh, Chief Executive Officer

Phone: +1 (760) 929 2840

E-mail: limor@spectral-imaging.com

www.spectral-imaging.com 

Biocare Medical LLC

Rhonda Henshall-Powell, Ph.D., Director of Marketing and Education

Concord, CA 94520

Tel: +1-800-799-9499

Fax: +1-925-603-8080

E-mail: rhenshallpowell@biocare.net

Web: www.biocare.net

BioDot and Applied Spectral Imaging Cooperate to Deliver Automated Genetic Analysis Solution

Enabling end-to-end, automated workflow for FISH and Karyotyping, from slide production to sample analysis and result reporting

Carlsbad, California and Irvine, California , June 4, 2013 –Applied Spectral Imaging Inc. (ASI) and BioDot Inc. have entered into an agreement in which both companies will engage in combined sales and marketing of an integration product that will directly link the GenASIs imaging and analysis instrument by ASI and the CellWriter™ automated dispensing system for FISH and Karyotyping by BioDot. The combined solution enables an end-to-end, automated workflow for FISH and Karyotyping, from slide production to sample analysis and result reporting.

“Personalized medicine challenges laboratories to continuously expand their genetic analysis throughput rapidly and cost effectively.  The ASI and BioDot platforms provide an end-to-end environment for managing samples from slide preparation to the generation of the analysis report.”  said Limor Shiposh, CEO of Applied Spectral Imaging Inc. “Our combined offering for automated genetic analysis leverages the imaging and analysis accuracy, speed and quality results of ASI’s GenASIs platform with the flexibility, efficiency and simplicity of BioDot’s CellWriter™ automated dispensing system for FISH and Karyotyping”  added Mrs. Shiposh.

“We are excited to work with ASI on a combined automated workflow solution for FISH and Karyotyping. The cytogenetics workflow is highly complex and by integrating automated slide processing with automated microscopy, we can now deliver a data management product that greatly simplifies the scientist’s workday. BioDot’s CellWriter™ is able to automate cell dropping to deliver quality spread interphase and metaphase nuclei for analysis, bridging the automation gap between harvesting and automated microscopy, and bringing high throughput processing to this market. ” said Tom Tisone, CEO of BioDot Inc.

ASI and BioDot have confirmed the combined solution’s effectiveness in performing automated FISH and karyotyping. As a part of the new product offering, the two companies will offer a set of software connectors enabling bidirectional and seamless data integration between the two solutions.

About Applied Spectral Imaging

Applied Spectral Imaging (ASI) makes patient care better through advanced biomedical imaging.

GenASIs by ASI is FDA cleared for FISH clinical applications such as ALK, UroVysion, HER2/neu, CEP XY and Karyotyping. ASI complies with major regulatory requirements and international quality standards.

ASI has been one of the industry’s leading microscopy imaging solution providers since 1993, with over 30 registered patents in the US, Europe and Japan and over 2,500 systems deployed worldwide. With worldwide offices in the US, Europe and Asia, ASI has built a global network of over 50 distributors.

About BioDot

BioDot is the leading supplier of system tools for the research, development, and commercialization of diagnostic tests. Our mission is to enable, inspire and educate scientists to commercialize their R&D ideas through to manufactured product. Using our core competencies in low volume non-contact dispensing, BioDot has developed the FISHArrayTM technology and CellWriterTM workstation to streamline the cytogenetics workflow and deliver high throughput automation.

With a commitment to fully understanding our customer requirements, BioDot’s personnel have a genuine wish to help you develop your research ideas. Our sales teams are highly trained in providing expert advice in both process and material handling needs. They are backed by a strong support team of application scientists and service engineers.

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For More Information Contact –

Applied Spectral Imaging Inc.

Mrs. Limor Shiposh, Chief Executive Officer

Phone: +1 (760) 929 2840

E-mail: limor@spectral-imaging.com

www.spectral-imaging.com 

BioDot, Inc.

Brian Kirk, Product Manager – Molecular Diagnostics

Irvine, CA 92612

Tel: +1-949-440 3685

Fax: +1-949-440 3694

Email: brian.kirk@biodot.com

Web: www.biodot.com

Applied Spectral Imaging and WaveSense to Cooperate in Molecular Pathology and Cytogenetic FISH

Delivering a state-of-the-art integrated computerized analysis instrument and cell enrichment solution

Carlsbad, California and Irvine, California , April 22, 2013 –Applied Spectral Imaging Inc. (ASI) and WaveSense Inc. have entered into an agreement in which both companies will engage in combined sales and marketing of the GenASIs imaging and analysis instrument by ASI and the EpiSEP cell recovery and enrichment solution by WaveSense. The combined solution delivers an integrated cell capturing solution and computerized instrument to detect, image and analyze the captured cells.

“We are excited to be working with WaveSense to deliver combined state-of-the-art computerized imaging and analysis using ASI’s GenASIs platforms with WaveSense’s EpiSEP cell recovery and enrichment product. Our combined offering for molecular pathology and cytogenetics leverages the imaging and analysis accuracy, speed and quality results of GenASIs with the improved workflow, flexibility, efficiency and simplicity of EpiSEP and this, in turn, brings unparalleled value to our customers”  said Limor Shiposh CEO of ASI Inc.

“Personalized medicine challenges laboratories to continuously evolve and expand their molecular pathology applications rapidly and cost effectively.  WaveSense and ASI platforms provide a straightforward versatile environment for optimizing existing applications or implementing new applications.  The diagnostic specificity, diagnostic sensitivity, workflow efficiencies, and robustness that our combined platforms can assert on an application are tremendous. The GenASIs platform is very accessible and user friendly, it expertly complements the simplicity and ease of use of our EpiSEP platform. The new combined platform is ideally suited for containing, imaging and analyzing paramagnetic labeled target cells within the EpiSEP slide.” Said Chris Feistel CEO of WaveSense Inc.

ASI and WaveSense have confirmed the combined solution’s effectiveness in performing semi-automated FISH analysis of paramagnetic labeled target cells. Target cells may be retrieved, enriched, imaged and analyzed in urine, bone marrow, blood, needle aspiration, abdominal ascites, lymph node, culture and pleural effusion specimens.

About Applied Spectral Imaging

Applied Spectral Imaging (ASI) makes patient care better through advanced biomedical imaging.

GenASIs by ASI is FDA cleared for FISH clinical applications such as ALK, UroVysion, HER2/neu, CEP XY and Karyotyping. ASI complies with major regulatory requirements and international quality standards.

ASI has been one of the industry’s leading microscopy imaging solution providers since 1993, with over 30 registered patents in the US, Europe and Japan and over 2,500 systems deployed worldwide. With worldwide offices in the US, Europe and Asia, ASI has built a global network of over 50 distributors.

About WaveSense

WaveSense develops, manufactures, and markets award winning breakthrough analytical nanotechnologies for use in cellular and molecular assay markets. Some applications we actively engage in consist of drug discovery, companion diagnostic development, veterinary diagnostics, and rare cell detection in blood, urine, and bone marrow.

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For More Information Contact –

Applied Spectral Imaging Inc.

Mrs. Limor Shiposh, Chief Executive Officer

Phone: +1 (760) 929 2840

E-mail: limor@spectral-imaging.com

www.spectral-imaging.com 

 

WaveSense Inc.

15339 Barranca Parkway

Irvine, California, USA 92618

Tel: +1  (949) 341-1980

Web: www.wavesense.net

World’s First FDA Cleared ALK Automated Gene Scanner for Lung Cancer Therapy-Selection Available from ASI

Targeting the Right Treatment for the Right Patient in ALK Therapy Selection for Non-Small-Cell Lung Cancer

Carlsbad, CA. – Feb 13, 2013 – Applied Spectral Imaging (ASI, www.spectral-imaging.com) announced today that its GenASIs Scan & Analysis automated microscopy platform has received FDA clearance as an aid in ALK gene analysis for lung cancer therapy selection. The introduction of automation in ALK therapy selection represents a new era in personalized medicine for patients with NSCLC (Non-Small-Cell-Lung-Cancer).

About 85% of lung cancer patients have NSCLC and are commonly diagnosed at an advanced disease stage with very low survival rate. Lung cancer is the leading cause of cancer related death in the US with over 1.6 million new cases diagnosed annually.

GenASIs Scan & Analysis offers clinicians a way to automatically perform genetic analysis on tissue samples, stained with the Abbott ALK™ probe kit, and identify the ALK gene rearrangement.

Automated genetic analysis with GenASIs Scan & Analysis ensures quick, repeatable and documented results proving unparalleled clinical accuracy and time savings. GenASIs further adds the ability to perform “walk away” automated genetic tissue scanning for ALK using an 81 slide continues scanning robot.

The Abbott Vysis ALK Break Apart FISH Probe test is designed to identify ALK-positive NSCLC patients for Pfizer’s approved NSCLC therapy, XALKORI® (crizotinib), an oral first-in-class ALK inhibitor. The Vysis test uses in situ hybridization (FISH) technology to detect rearrangements of the ALK gene on the 2p23 chromosome. The diagnostic test offers clinicians a standardized, clinically validated method to identify patients more likely to benefit from XALKORI® (crizotinib) therapy.

“We are proud to be the first to offer an automated platform to aid in ALK therapy selection for Non-Small-Cell Lung Cancer patients. This significant achievement further affirms ASI’s commitment to offer new and innovative tools to make personalized medicine using companion diagnostics more available and more effective.” said Limor Shiposh, ASI’s Chief Executive Officer.

Limor further added, “ALK is an important addition to our suite of FDA cleared computerized clinical diagnostic aids. We plan to expand our portfolio of FDA cleared tools in our GenASIs platform to better serve our customers in achieving more accurate clinical results, quicker and more cost effectively.  I am confident that this addition will help further establish ASI as the world leader in automated and manual FISH imaging and analysis.”

About ASI

Applied Spectral Imaging (ASI) makes patient care better through advanced biomedical imaging.

GenASIs by ASI is FDA cleared for FISH clinical applications such as ALK, UroVysion, HER2/neu, CEP XY and Karyotyping. ASI complies with major regulatory requirements and international quality standards.

ASI has been one of the industry’s leading microscopy imaging solution provider since 1993, with over 30 registered patents in the US, Europe and Japan, and over 2,500 systems deployed worldwide. With worldwide offices in the US, Europe and Asia, ASI has built a global network of over 50 distributors.

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For More Information Please Contact –

For More Information Contact –

Mrs. Limor Shiposh, Chief Executive Officer

Phone: +1 760 929 2840

E-mail: limor@spectral-imaging.com

www.spectral-imaging.com 

Applied Spectral Imaging Launches Version 7.2 of GenASIs – A New Era in Pathology and Cytogenetic Imaging

GenASIs 7.2 – The Market’s most Comprehensive Computer Aided Cytogenetic and Pathology Imaging and Analysis Platform

Carlsbad, CA. – Dec. 18, 2012 – Applied Spectral Imaging (ASI, www.spectral-imaging.com) announced today the launch of Version 7.2 of GenASIs – a comprehensive cytogenetic and pathology imaging platform.

GenASIs Version 7.2 introduces major enhancements to ASI’s offering of existing imaging applications and positions ASI as a leader in both cytogenetic and pathology imaging and analysis. The new platform offering includes unparalleled accuracy and efficiency for automated and interactive imaging applications. In addition, GenASIs Version 7.2 includes advance imaging applications from fully automated to fully interactive workflows for tissue FISH and cytogenetic FISH, Immunohistochemistry (IHC) analysis, karyotyping (including automated metaphase finding).

“The introduction of GenASIs 7.2 is our first step in establishing ASI as a leader in automated and interactive pathology and cytogenetic imaging and analysis. We are excited to add Quantitative IHC pathology imaging and analysis, along with other important enhancements, to our flagship platform – GenASIs. This new offering is in line with our strategy to offer clinicians and researchers the most advanced, efficient and accurate instruments supporting advancements in computer-aided analysis for personalized medicine, companion diagnostics, cancer research, diagnostic and other pathology and cytogenetic applications.” said Limor Shiposh, CEO of Applied Spectral Imaging.

The launch of GenASIs Version 7.2 introduces both enhancements as well as new capabilities to the GenASIs imaging and analysis platform. These enhancements include the combining fluorescent and bright-field pathology analysis with both IHC and FISH imaging and analysis in a single platform. Moreover, GenASIs introduces new levels of automation and time-savings adding Microsoft Windows 7 64bit operating system support as well as optimized workflows for fully-interactive FISH spot-counting and enhanced analysis capabilities. Other enhancements include improved laboratory information system (LIS) integration and management tools including detailed audit-trail, backup, recovery and maintenance.

“We have learnt from our customers that combining cytogenetic and pathology analysis adds real value making patient care better and more affordable. Furthermore, our customers have asked for a flexible solution suite supporting fully-automated “walk-away” as well as fully interactive imaging and analysis. We have listened to our customers and are proud to introduce the GenASIs Version 7.2 platforms including our new Go-Path quantitative IHC analysis platform” said Yagil Tzur, Program Director at Applied Spectral Imaging.

About ASI

Applied Spectral Imaging (ASI) makes patient care better through advanced biomedical imaging.

GenASIs by ASI is FDA cleared for FISH clinical applications such as UroVysion, HER2/neu, CEP XY and Karyotyping. ASI complies with major regulatory requirements and international quality standards.

ASI has been one of the industry’s leading microscopy imaging solution provider since 1993, with over 30 registered patents in the US, Europe and Japan and over 2,500 systems deployed worldwide. With worldwide offices in the US, Europe and Asia, ASI has built a global network of over 50 distributors.

 

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For More Information Please Contact –

For More Information Contact –

Mrs. Limor Shiposh, Chief Executive Officer

Phone: +1 (760) 929 2840

E-mail: limor@spectral-imaging.com

www.spectral-imaging.com 

Olympus Europa and Applied Spectral Imaging Expand Cooperation by Establishing Sales and Marketing Framework Agreement

The agreement further outlines Olympus Europa’s and Applied Spectral Imaging’s commitment and intent to cooperate in the distribution of state-of-the-art pathology and cytogenetic microscopy imaging solutions in Europe

Hamburg, Germany and Carlsbad, Calif., May 29, 2012 – OLYMPUS Europa Holding GmbH and Applied Spectral Imaging (ASI) Ltd. today signed a European framework agreement outlining the terms for distribution by Olympus subsidiaries in Europe of the GenASIs automated imaging platforms for genetic and pathological analysis. This agreement underlines both companies’ intent to establish cooperation with individual Olympus distributors in Europe. These agreements will be based on the Framework Agreement to deliver integrated computer aided microscopy imaging and analysis for cytogenetics and pathology.

The GenASIs advanced cytogenetic and pathology platforms are the foundation of ASI’s offering. With its superior imaging and analysis capabilities, ASI provides state-of-the-art diagnostic aids, offering cytogeneticists and pathologists accurate biomedical analysis.

GenASIs enables automated pathology tissue analysis for primary diagnostics, creating reproducible and reliable results. The GenASIs platforms offer a comprehensive solution ensuring reliability and quality results every time, while allowing cytogeneticists, pathologists and technologists to focus on the clinical rather than the technical components.

GenASIs is FDA cleared for FISH clinical applications such as UroVysion, HER2/neu, CEP XY and Karyotyping.

ASI’s advanced solutions integrated with Olympus’ microscopy solutions accommodate the market demand for faster, more powerful imaging and analysis tools. This unparalleled synergy caters to the growing market need for high throughput solutions empowering laboratories to do more with less.

GenASIs will complement Olympus’ solutions by offering an integrated imaging, digital image capture and biomedical analysis platform.

“We are excited about our cooperation with Olympus. Cooperating with the world’s leader in microscopy will further enhance ASI’s position as the leaders in computer aided biomedical microscopy imaging and analysis” said Limor Shiposh, CEO of Applied Spectral Imaging.

With this co-operation agreement both companies show their commitment of working together in order to offer more competitive integrated solutions and to facilitate the daily work in medical applications.

About OLYMPUS Europa Holding GmbH

Since Olympus was founded in Japan in 1919, it has become a leading manufacturer of innovative optical and digital equipment for the healthcare and consumer electronics sectors. For over 90 years it has led the way in designing endoscopy and microscopy equipment for both medical and industrial use, and it is well known for its groundbreaking camera and voice recorder ranges.

The Olympus Europe Group posted a turnover of EUR 1,386 million in the financial year 2011-2012. Its European head office is located in Hamburg, Germany. The Olympus Europe Group employs some 4,700 people either at the European headquarters or at one of the 44 subsidiary companies.

About Applied Spectral Imaging

Applied Spectral Imaging (ASI) makes patient care better through advanced biomedical imaging.

GenASIs by ASI is FDA cleared for FISH clinical applications such as UroVysion, HER2/neu, CEP XY and Karyotyping. ASI complies with major regulatory requirements and international quality standards.

ASI has been one of the industry’s leading microscopy imaging solution provider since 1993, with over 30 registered patents in the US, Europe and Japan and over 2,500 systems deployed worldwide. With worldwide offices in the US, Europe and Asia, ASI has built a global network of over 50 distributors.

# # #

For More Information Contact –

Applied Spectral Imaging

Limor Shiposh, Chief Executive Officer

Tel: +1(800) 611-3466

E-mail: limor@spectral-imaging.com

Web: www.spectral-imaging.com 

 

On behalf of OLYMPUS EUROPA HOLDING GMBH

Paul Avery (PR Account Manager)

Alto Marketing,

Southampton, UK

Tel: +44 (0) 1489 557 672

Fax: +44 (0) 1489 559 246

E-mail: paulavery@alto-marketing.com

Web: www.microscopy.olympus.eu

FDA Clears ASI’s GenASIs Advanced Imaging for HER-2/neu Analysis

Monday, February 20, 2012

Targeting the Right Treatment for the Right Patient in Breast Cancer Diagnostics 

Carlsbad, Calif., February 20, 2012 – – Applied Spectral Imaging (ASI) announces that ASI’s GenASIs automated scanning and image analysis system for detection and quantification of chromosome 17 and the HER-2/neu gene has been cleared by the United States Food and Drug Administration (FDA) for marketing in the US.

Detection and analysis are concluded via Fluorescence In Situ Hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens.

GenASIs Scan and Analysis is intended for in-vitro diagnostic use as an adjunctive automated enumeration tool to assist cytogeneticists and pathologists in detecting amplifications of the HER-2/neu gene in human breast cancer specimens.

With the introduction of GenASIs 7, ASI has broadened its FDA cleared portfolio and now provides three major FDA cleared tests; HER2/neu FISH – an aiding tool in breast cancer , CEP XY – used for assessing the effectiveness of bone marrow transplantation in opposite-sex transplants and UroVysion – used for detecting cells in urine specimens from persons suspected of having bladder cancer.

ASI’s manual and automated scanning platform and image analysis systems enable laboratories to provide highly reliable Her2/neu FISH test results quickly and cost-effectively.

Limor Shiposh, ASI’s Chief Executive Officer said, “We are pleased to have received an additional and important FDA clearance. We plan to expand our portfolio of FDA cleared tools in our GenASIs platform to better serve our customers in achieving more accurate clinical results, quicker and more cost effectively.  I am confident that this addition will help further establish ASI as the world leaders in automated and manual FISH imaging and analysis.”

About ASI

Applied Spectral Imaging (ASI) makes patient care better through advanced biomedical imaging.

The GenASIs Automated Imaging Platforms for Genetic and Pathological Analysis are the foundation of ASI’s offering. With superior imaging and analysis capabilities, ASI provides state of the art diagnostic aids, offering cytogeneticists and pathologists accurate analysis. GenASIs enables automated tissue analysis for primary diagnostics, with reproducible and reliable results. GenASIs Hyperspectral with HiSKY® Probes adds a new dimension to biomedical image analysis.

GenASIs is FDA cleared for FISH clinical applications such as UroVysion, HER2/neu, CEP XY and Karyotyping. ASI complies with major regulatory requirements and international quality standards.

ASI is the industry’s leading microscopy imaging solution provider since 1993, with over 30 registered patents in the US, Europe and Japan and over 2,500 systems deployed worldwide. With worldwide offices in the US, Europe and Asia, ASI has built a global network of over 50 distributors.

 

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For More Information Contact –

Mrs. Limor Shiposh, Chief Executive Officer

Phone: +1760 929 2840

E-mail: limor@spectral-imaging.com

www.spectral-imaging.com 

FDA Clears ASI’s GenASIs Advanced Imaging for UroVysion Analysis

GenASIs Scan & Analysis cleared for FISH Detection and Analysis of chromosomal abnormalities in urine specimens 

Carlsbad, Calif., January 30, 2012 – Applied Spectral Imaging (ASI) announced today that ASI’s GenASIs Scan & Analysis, SpotScan used for the detection of chromosomal aberrations in bladder cancer has been cleared by the United States Food and Drug Administration (FDA) for marketing in the US.

GenASIs Scan and Analysis, SpotScan is intended for in-vitro diagnostic use as a diagnostic aid for automated and manual classification of bladder cancer cells. Cells of interest are targeted based on color size and their signals pattern assisting in the diagnosis of bladder carcinoma in patients with hematuria. GenASIs Scan & Analysis, SpotScan also assists in the subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

With the introduction of GenASIs 7, ASI has broadened its FDA cleared portfolio and now provides 3 major FDA cleared computerized diagnostic aids for: breast cancer – HER2/neu, CEP XY for counting and classifying fluorescent signals in interphase nuclei and the newly cleared UroVysion test for the detection of cells in urine specimens.

ASI’s manual and automated scanning platform and image analysis systems enable laboratories to provide highly reliable UroVysion test results quickly and cost-effectively.

Dr. Felipe Dominguez MD, President and CEO of Suncoast Pathology Associates said, “Using the GenASIs system from ASI is like having an efficient robotic assistant helping us perform fully automated UroVysion® Bladder Cancer scanning.” Dr. Dominguez further added that “The combined microscope and computer-aided image analysis capabilities of GenASIs help us give faster and more accurate clinical results. GenASIs takes automated UroVysion scanning and analysis to a new level.”

Limor Shiposh, ASI’s Chief Executive Officer said, “We are pleased to have received this important FDA clearance. We plan to expand our portfolio of FDA cleared tools in our GenASIs platform to better serve our customers in achieving more accurate clinical results, quicker and more cost effectively.  I am confident that this addition will help further establish ASI as the world leaders in automated and manual FISH imaging and analysis.”

UroVysion is used for the detection of cells in urine specimens, stained with fluorescence in situ hybridization (FISH) using Vysis UroVysion® Bladder Cancer Kit.

About ASI

Applied Spectral Imaging (ASI) makes patient care better through advanced biomedical imaging.

The GenASIs Automated Imaging Platforms for Genetic and Pathology Analysis are the foundation of ASI’s offering. With superior imaging and analysis capabilities, ASI provides state of the art diagnostic aids, offering cytogeneticists and pathologists accurate analysis. GenASIs enables automated tissue analysis for primary diagnostics, with reproducible and reliable results. GenASIs Spectral with HiSKY® adds a new dimension to biomedical image analysis.

GenASIs is FDA cleared for clinical applications such as UroVysion, HER2/neu FISH, CEP XY, Karyotyping and FISH. ASI complies with international quality standards including ISO, CE, CMDCAS and 21CFR part 820.

ASI is the industry’s leading microscopy imaging solution provider since 1993 with over 30 registered patents in the US, Europe, Japan and the rest of the world. With worldwide offices in the US, Europe and Asia, ASI has built a global network of over 50 distributors.

 

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For More Information Contact –

Mrs. Limor Shiposh, Chief Executive Officer

Phone: +1 760 929 2840

E-mail: limor@spectral-imaging.com

www.spectral-imaging.com