New York State Department of Health Approves PathoZoom Rapid On Site Evaluation in Fine Needle Aspirates Specimens LDT

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The New York State Department of Health has approved Cayuga Health System to use a Smart In Media PathoZoom LiveView laboratory developed test (LDT) image-based method for digital slide sharing - Rapid On Site Evaluation (ROSE) in fine needle aspirates specimens, the company said on Tuesday.

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Business Wire, Inc.Business Wire, Inc.
Retrieved on: 
Thursday, May 4, 2023
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Health Technology, Health Insurance, Data Management, Other Health, Technology, Healthcare Reform, General Health, Medical Devices, Infectious Diseases, Public Policy, Government, Clinical Trials, Other Technology, Science, Research, Health, Medical Supplies, Cloud, LiveView, Laboratory, LDT, Travel, Workflow, Marie Cassidy, CLEP, NYSDOH, ROSE, New York State Department of Health, Medical director, Scan, Television, Medical device
Geotags: 
NORTH CAROLINA, NEW YORK, UNITED STATES, NORTH AMERICA, USA
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SMART IN MEDIA, SMART IN MEDIA, INC.
Summary
Key Points: 
  • The New York State Department of Health has approved Cayuga Health System to use a Smart In Media PathoZoom LiveView laboratory developed test (LDT) image-based method for digital slide sharing - Rapid On Site Evaluation (ROSE) in fine needle aspirates specimens, the company said on Tuesday.
  • With the approval, Cayuga can begin testing patient samples using its PathoZoom system in the state of New York through its CLIA-certified laboratory.
  • The Clinical Laboratory Evaluation Program (CLEP) used to validate the assay is among the most important and rigorous levels of validation for LDTs, Smart In Media noted.
  • Each LDT submitted to the NYSDOH must undergo review for analytical and clinical performance, as well as reproducibility.


The New York State Department of Health has approved Cayuga Health System to use a Smart In Media PathoZoom LiveView laboratory developed test (LDT) image-based method for digital slide sharing - Rapid On Site Evaluation (ROSE) in fine needle aspirates specimens, the company said on Tuesday.

With the approval, Cayuga can begin testing patient samples using its PathoZoom system in the state of New York through its CLIA-certified laboratory.

The Clinical Laboratory Evaluation Program (CLEP) used to validate the assay is among the most important and rigorous levels of validation for LDTs, Smart In Media noted. Each LDT submitted to the NYSDOH must undergo review for analytical and clinical performance, as well as reproducibility.

“This technology extends pathologist reach, both temporally and geographically. It is critical to our workflow, which requires the most efficient use of the scarce pathologist resource,” said Elizabeth Plocharczyk MD, CEO of Excelsior Pathology and Medical Director of the Laboratories of Cayuga Health System. Dr. Plocharczyk oversaw the LDT application.

"This approval marks a significant regulatory milestone for Smart In Media in the USA and is a key step to our broader market acceptance and use," said Don Van Dyke, VP and General Manager of Smart In Media, Inc. "And this approval of PathoZoom Scan and LiveView includes our Slide Cloud storage component. Labs can now multiply pathologists' availability at remote sites, reduce travel and increase flexibility."

About Smart In Media, Inc.

As a solution partner and leader in digital pathology, Smart In Media moves pathologists quickly forward in diagnostics and teaching.

For information visit https://www.smartinmedia.com/usa/.

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