Olympus Soft Imaging Solutions GmbH (OSIS), a leading system solution provider in microscopy and PathXL Ltd., a company that specialises in developing web-based software for digital pathology, announced today a non-exclusive worldwide original equipment manufacturer (OEM) software distribution agreement for PathXL’s Digital Pathology Education Solutions.  Under the partnership, OSIS will market and sell PathXL’s solutions for training, development, education, testing and quality assessment purposes to the Digital Scientific Education market. 

OSIS, well-known in the scientific micro imaging field, will expand their offering to include digital pathology education applications; Olympus E-Learning Solution powered by PathXL will be showcased at the 11^th European Congress of Telepathology and 5^th International Congress on Virtual Microscopy in Venice, 6 - 9 June.

Olympus E-Learning Solution will enable users to effectively create and manage digital slides and other content, publish online, share and view from anywhere in the world. The solution provides on-line virtual microscopy teaching, educational, CPD and competency exam resources in minutes, significantly enhancing student, trainee and the professional experience.  The solution also incorporates a platform which supports early stage training for residents in pathology.  Trainees can work through real cases and assess how well they have performed.  The software will be available directly from OSIS worldwide.

Commenting on the agreement, Dr. Tobias Schilling, Section Manager of Olympus Soft Imaging Solutions, stated

“The OLYMPUS VS120 is an advanced digital slide scanning system for brightfield and fluorescence applications.  It offers a complete spectrum of functionality for Research, Training including Remote Conferencing and Consultations tools. With the integration of PathXL’s Digital Pathology Education Solutions we enlarge our solutions by a complete Digital Learning Environment.  Our customers will benefit from PathXL’s long-term experience in the field of digital pathology and a fully integrated solution offered by Olympus.”

Philip Murray, Executive Vice President of PathXL, stated

“We are delighted to enter this strategic partnership with Olympus Soft Imaging Solutions.  PathXL are specialists in delivering digital pathology education software applications.  The partnership enables the company to continue its rapid expansion throughout Europe, UK and beyond.  Olympus Soft Imaging Solutions and PathXL are well positioned to be the market leader within digital pathology medical education.”

About PathXL

PathXL specialises in web-based software and workflows for Digital Pathology.  Its PathXL™ Manager product provides a robust, secure and open web-based platform to enable digital pathology users across all fields to manage, view and collaborate around virtual slides easily and efficiently.  In addition, PathXL provides a range of applications and workflows on top of PathXL™ Manager to deliver specific solutions to pathologists, scientists and students in Education, Research, Clinical and Biobanking settings.  PathXL also provides a full range of supporting services, including scanning, hosting, image analysis and consultancy.  PathXL operates in the UK, Europe and North America.

PathXL is a privately owned company, headquartered in Belfast, Northern Ireland.  For more information please visit: http://www.pathxl.com

About Olympus Soft Imaging Solutions GmbH

Olympus Soft Imaging Solutions strives to develop and build effective hardware and software solutions for microscopic image processing and analysis.  Their team of engineers, scientists, and service specialists provide complete training and service to satisfied customers in sciences and industries.  Olympus Soft Imaging Solutions generates synergies, offering a unique opportunity for establishing a “Center of Competence and Excellence” for Olympus operations in the scientific micro imaging field.

For more information visit: http://www.olympus-sis.com/

The post below I wrote about three years ago and at that time did not mention that the caller was inquiring about my interest and ability to participate in the FDA panel looking at digital pathology back in the Fall of 2009.  That panel of course was put together which I have mentioned on prior occasion (see The FDA States, WSI Systems Are Not Class I Exempt (10/23/2009)).  

Nothing of significance happened until the FDA was invited to speak at Pathology Visions 2011 which I made a few notes about on a related story earlier this year (see Regulators regulating digital scanners).

Since that discussion there appears to be a standoff between manufacturers and the FDA.  

There does not appear to be any movement by either side short of the FDA opening up some positions for digital pathology specialists (more on this next week).

Manufacturers appear to be either (1) looking for opportunities overseas to sell products and services, (2) looking at leveraging cloud computing to facilitate consultations (from overseas or within the USA) or (3) waiting for each other to submit for the first intended use studies while the FDA waits for submissions after stating publicly that whole slide imaging devices would not be considered Class I devices (exempt) and cannot be treated as a laboratory developed test (LDT).  In the meantime, "Approved for Primary H&E Diagnosis" is not available in the US of A.

Based on the post below given my first interaction with FDA on this matter I cannot say that any of this is terribly surprising.  Neither side, particularly the FDA seems that intersted in putting the necessary resources behind this matter on behalf of the imaging or the laboratory community to facilitate necessary validation and clearances.  I can't blame the manufacturers here either.  It is going to take significant time and resources in a difficult business climate with slow adoption and use for what will have to be clearly defined intended uses and therefore limited use whether by tissue type, specimen source and/or defined or excluded histochemical/immunohistochemical/fluorescence stains.

When will the standoff end?

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Where's Mayo Clinic? Oh, Minnesota is in the middle (8/28/2009)

A couple of weeks ago - 6:30 AM phone call

This interaction actually happened and reminded me of this New Yorker cartoon about New York and “everything else”.

Caller: Dr. Kaplan, this is Mr. So and So from the [name of a government agency].  I am calling to inquire about your interest in reviewing grant submissions.  I hope you are not driving.

Me: No.  I was sleeping.

Caller: Good.  I hope I am not disturbing you but I need to know if you can come to [a city in the US] in January when we convene the review panel.

Me: What dates In January?

Caller: We do not know yet but I need to know right now if you can come.

Me: I suppose it depends a little bit on what I will be reviewing, if I have anything to offer and if I don't have a prior conflict.

Caller:  OK.  I will just need to collect some basic information such as your social security number, home address and place of employment. 

Me: Mayo Clinic.

Caller: Where is Mayo Clinic?

Me: Rochester, Minnesota.

Caller: Where is Minnesota?

At this point I start asking some questions about who this individual is, his civilian pay grade, where his office is located, how he knew where to contact me and check the caller ID for area code.

Me: Have you seen 'Taking Chance'?

Caller: No.

Me: 'Fargo'?

Caller: No.

Me: 'Grumpy Old Men'? 

Caller: No. What time zone are you in?

Me: Central.

Caller: Oh, Minnesota is in the middle.

Waterloo, ON- Huron Technologies announces the launch of the TISSUEscope™ 4000XT with Autoloader Module for high volume and high throughput scanning. The fully-integrated system offers imaging of small and large glass slides for both brightfield and confocal fluorescent imaging modes and is designed to be compatible with all versions of TISSUEscope™ scanners.

The TISSUEscope™ 4000XT is capable of scanning up to 300-1x3” (25x75mm) glass slides as well as other non-traditional slide sizes including: 150-2x3” (50x75mm), 100-3x4” (75x100mm) and 25-large glass slides sizes for 4x5” (100x125mm), 5x7” (125x175mm) and 6x8” (150x200mm).

With its automatic scanning capability, the TISSUEscope™ 4000XT facilitates extended and overnight operations for labs which provide highly-efficient processes allowing staff to complete other tasks simultaneously.  By significantly increasing the number of slides scanned at one time, labs can enjoy substantial time-savings by reducing set-up delays but also extensive cost-savings through a decrease in lab expenses and processing time. 

The TISSUEscope™ 4000XT is easily controlled by the TISSUEscope™ client software where both automatic or manual control modes are available to customers.

With this launch Huron Technologies becomes the first in the industry to offer high-throughput scanning of small and large specimen samples for both brightfield and confocal fluorescence imaging.

Westminster, CO -- Flagship Biosciences announces today the acquisition of IHCtech LLC at the Colorado Anschutz Medical Campus. Founded in 2002, IHCtech has developed a strong reputation for high-quality advanced immunohistochemistry procedures, meeting the IHC and histology needs of pharmaceutical and academic investigators.

“We have partnered with Flagship Biosciences on a number of new techniques and approaches for quantitation in immunohistochemistry,” said Patsy Ruegg, owner and founder of IHCtech. “Their approaches to whole slide analysis and commitment to quantitative pathology makes a perfect partner with IHCtech’s expertise in high quality histology and immunohistochemistry. We enthusiastically look to further innovation by evaluating all aspects of the tissue chain -- tissue procurement, fixation and processing, with the ability to measure with whole slide analysis how each of these steps contribute to variability in the overall process.”

“While Flagship Biosciences has established strong partnerships with a number of highly respected IHC laboratories, both within the United States and internationally, this acquisition gives us the opportunity to internally evaluate tissue staining and implement new processes that better equip immunohistochemistry operations for use in quantitative pathology with whole slide imaging analysis,” said Dr. David Young, President of Flagship Biosciences. “Patsy Ruegg’s leadership in the area of high-quality research immunohistochemistry has been clear for many years. She has been a consistent expert in new IHC techniques like dual staining as well as a longtime leader in training of histology personnel.”

Flagship Biosciences specializes in tissue-based companion diagnostics, IHC biomarker development and histopathology assessment of discovery, safety and toxicity using brightfield and fluorescent whole slide imaging. The company provides a full service of tissue analysis for drug and device development, including tissue procurement, tissue preparation and immunohistochemistry, whole slide quantitative computer-based evaluation, with all services overseen by veterinary and medical anatomic pathologists

IHCtech provides high-quality histology, immunohistochemistry, and immunofluorescence to academic and pharmaceutical clients. With over 350 optimized research IHC antibodies, IHCtech brings a wealth of knowledge and expertise to the tissue analysis process.