Applied Spectral Imaging (ASI) announced today that its GenASIs^TM applications comply with CE-IVD requirements under the European Directive on In Vitro Diagnostic Medical Devices, for automated analysis with the IQFISH lung cancer panel on Dako Omnis (comprising of ALK, ROS1, RET and MET IQFISH probes) of Agilent Technologies Inc. (NYSE: A).

This clearance delivers to pathology labs the best of both worlds – ASI’s unmatched workflow efficiencies and enhanced accuracy, with Agilent’s new high-quality IQFISH lung cancer panel. The result ensures optimal performance and standardization of FISH analysis, without compromising the laboratories’ certification standards.

“This latest CE-IVD conformity is evidence of our commitment to improve patient care. Laboratories can now have a fully optimized FISH workflow with greater image quality, that negates the time-consuming and costly need for internal validation,” said Limor Shiposh, chief executive officer of ASI. “Being recognized for our industry-leading FISH imaging platforms, ASI is proud to be the first to market imaging platforms that are CE-IVD conformed with Agilent’s new IQFISH lung cancer panel. We are certain that this solution will rapidly become the new gold standard for pathologists in Fluorescence-based molecular analysis”, Mrs. Shiposh added.

About ASI

ASI is a global leader in the development of imaging solutions, supporting fluorescent, brightfield and spectral image-acquisition, for various pathology tests, FISH and karyotyping.

The GenASIs™ automated imaging platforms for pathology and genetic analysis provide advanced diagnostic aids for pathologists and cytogeneticists, with reproducible and standardized results. GenASIs platforms support manual and automatic scanning for a wide range of workflows and applications, to best suit the needs, size and budget of any lab.

ASI’s GenASIs applications are FDA cleared for BandView, FISHView, CEP XY, UroVysion, ALK, HER2/neu FISH and IHC Family for: HER2, ER, PR and Ki67.

ASI serves clinical laboratories, life science companies and research institutions in over 50 countries.

For More Information Please Contact

Applied Spectral Imaging

Limor Gurevitch

Phone: +1 (760) 929-2840

E-mail: gurevitchl@spectral-imaging.com

www.spectral-imaging.com 

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 

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.

*****

For More Information Please Contact –

Applied Spectral Imaging

Phone: +1(800) 611-3466

E-mail: Sales@spectral-imaging.com

www.spectral-imaging.com

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

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

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

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