DMETRIX S (FUTURE) PERSPECTIVES ON DIGITAL IMAGING & DIGITAL PATHOLOGY SYSTEMS

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Michael R. Descour, Ph.D., DMetrix, Inc., & University of Arizona Lloyd J. LaComb, Jr., Ph.D., DMetrix, Inc. DMETRIX S (FUTURE) PERSPECTIVES ON DIGITAL IMAGING & DIGITAL PATHOLOGY SYSTEMS Outline of presentation Thanks to Robert Michel and his excellent staff for putting on these outstanding meetings Thanks to distinguished audience for staying the extra day Digital pathology market and trends DMetrix background Digital imaging background and the paradigm of parallel imaging Laboratory workflow and implications for imaging instruments Data storage considerations Concluding remarks

Digital pathology market Same trend as transformed radiology over last 2 decades Divided into research and clinical market sectors Adoption most advanced in research market This market sector is very receptive to digital imaging already Estimated 600-800+ systems installed world-wide Clinical market emergent Estimated by GE Healthcare to eventually reach $2B High throughput is essential Adoption lagging research market Fundamental enabling technology: convert glass slides to digital images, a.k.a., slide scanning Adoption of digital pathology Billing with 88305 and 88361, to estimate adoption of digital pathology among independent labs, hospitals, and pathology groups: Adoption at ~2-3%. Average global reimbursement is $62 vs. $91 per claim. Estimated Estimated growth growth rate: 15% rate: 15% Important developments: FDA clearances but very piecemeal Receptor/antibody specific, reagent specific, instrument specific Need more clearances with a broader scope Integration with information technology (LIS, PACS): In progress Data sources: CMS, Laboratory Economics.

A few words about DMetrix Company spun out from worldrenowned College of Optical Sciences and Telemedicine programs at University of Arizona Company founded by pathologists and engineers seven (7) years ago Continued advanced-microscopy work funded by the National Institutes of Health (5 funded SBIR grants) Multiple awards for innovation: 2 R&D 100 Awards, Wall Street Journal Runner Up, University of Arizona and AZ Governor s Awards Focus on innovation: 18 issued US patents, 14 patents pending, 2 licensed patents Point of reference: What we are trying to accomplish How to think about the number of pixels in one glass-slide image? Even though a slide is small imaging of biological specimens requires 100 s of millions of pixels.

Conventional whole slide scanning technologies Step-and-repeat approach ( image tiles ) Typical size of a tile is 0.75 millimeters on a side Pushbroom scanning with a linear detector array Typical swath width is 1 millimeter Image capture through a straw How to escape an uncomfortable trade off? Microscopy: Trade off between image detail and field of view Every microscope objective obeys this trade-off Solution: Keep adding objectives Move along top row PARALLEL IMAGING What does an array microscope actually look like?

DMetrix s parallel imaging: the array microscope Parallel-imaging concept, exists now as a product in context of digital pathology (histology & cytology) DX-40, EX-40, and multispectral imaging models 80 microscopes in one instrument Highest-throughput scanner on the market for the last 5 years Glass slide Benefits of DMetrix systems Rapid image acquisition High throughput, AND/OR Increased information content at pace of others Multiple colors; AND/OR Multiple z-planes Fast and safe slide handling Air-flow to move slides without touching Gauntlet of sensors monitors slide positions High sustained and unsupervised throughput Images output to various formats JPEG, BigTIFF, DICOM*, custom formats Compatible with 3 rd -party image analysis & image management software, including LIS software

Why is high throughput important? Observation: When our customers speak of digital pathology, they speak of using digital images, not taking them. The creation of digital images opens the gates to all sorts of valueadding processes. Examples include: sharing of digital data among professionals (2 nd opinion), automated image analysis (objective, quantitative, and reproducible), and workflow-efficiency improvements. To get there, glass slides have to be converted into digital files: No reason to delay that conversion. We think that high throughput is essential. We feel that it is the key factor needed to bring digital pathology to clinical practice. Not time per slides but instead slides/unit time. Work flow example Large batch process (650 slides) What are implications for an imaging instrument s throughput? 80 r 40 r 20 r Data from P. Chang s APIII 2008 presentation.

Saying Sayonara in many forms There is now a solution for every need Single slide scanners 5, 6, 7, 40, 80, 120, 300 slide capacity Throughput: 1, 10, up to 40 our Increasing throughput Workflow at the pathologist s s desk Key requirement: Ultrafast image viewing/navigation Standard: viewing a glass slide moved by hand To meet the standard, viewing may require a specialized workstation Software to aid pathologist in organizing/performing work Rapid access to other information about case Sort cases according to level of difficulty, per individual pathologist s preferences Computer aided review DMetrix s Focus software

Data storage costs Since 1990, the price per gigabyte has decreased an average 47% per year In October 2008, it reached $0.10, i.e., the cost of a slide + coverslip Today: $0.08/GB Circa 2011: Total cost of storing slide images expected to be dominated by capital costs (e.g., scanners, maintenance costs), not storage media 60 slides/ hour Conclusions Market adoption in the single percents, significant opportunity remains Challenging existing standard to match in terms of productivity To address this challenge in two fundamental ways, DMetrix has: Developed parallel imaging to accelerate image capture in digital pathology Highest throughput scanner product for the past five (5) years Up to 40 our Developed ultrafast image viewing to approximate microscope viewing Paradigm shift: Parallel imaging is a prerequisite for wide scale adoption of digital imaging and digital pathology Future: Opportunities for business models founded on image data But this requires that imaging can affordably provide a data pipeline

Acknowledgments Thanks go out to: DMetrix staff Our customers Dr. Ron Weinstein for his continuing inspiration You can reach me at: descour@dmetrix.com (520) 722 9510