Prostate Biopsy Processing: An Innovative Model for Reducing Cost, Test Time and Improving Diagnostic Material
Dip Shukla¹, Jennifer Morocho2, Deanne Smith¹, Drew Sciacca¹, Meghan Pickard¹, Michelle Wahlsten2, Ashley Gunderson2, Andy Thompson¹, Badrinath Konety1, Christopher Warlick¹, Paari Murugan¹
1University of Minnesota and 2Fairview Laboratories, Minneapolis, MN
107th Annual Meeting of the United States and Canadian Academy of Pathology, March 17-23, 2018, Vancouver, BC, Canada
Disclosure
Background
www.aviva.co.uk
Biopsy Gun
Rep image of TRUS prostate biopsy;
However, there are several concerns that exist with this procedure.
Prostate Needle Biopsy Concerns
http://www.prostrcision.com
These include process waste and tissue fragmentation.
These concerns are Unique to the prostate, as it is the Only organ that is subject to multiple and repeated systematic biopsies due to the multifocal nature of the disease.
The conventional protocol…
The other concern is fragmentation.…compromises BOTH cancer quantitation and diagnostic accuracy
Process Waste
To elaborate on process waste, here we can see the large amount of materials consumed for each biopsy case.
This leads to Redundancy of non-automated processes: like grossing, embedding, and sectioning
And excessive slides for path..
And 3 or 4 cases can easily add up to this stack that most of you are familiar with
The cost of IHC and storage space also increases -Antithesis of LEAN lab practice
Tissue Fragmentation
Tissue fragmentation is also of great concern. It is seen at various steps of processing, where the specimen is handled by forceps. Specifically during specimen procurement (where to-and-fro movement is used to dislodge the sample from the biopsy gun). Fragmentation is also seen in grossing and embedding.
The delicate needle cores, especially when they contain cancer, fragment due to the high gland to stromal ratio, typical of high grade cancer.
Price of Fragmentation
With fragmentation, Two types of diagnostic errors lead to inappropriate patient management.
Artificially elevate cancer quantitation.
Both of these errors could potentially lead to a difference in management.
Baseline Data
Linear fragments
Non-linear fragment
Baseline data was obtained to characterize the issue. At the UMN we process about 500 cases annually and these were used to inform our initial understanding of the issue.
We evaluated 3 main metrics, the first …
We also evaluated the time and fragmentation rate in 48 test cases:
The time metric focused on…
While the last and most important metric characterized the fragmentation.
Linear fragmentation is defined as in-line separation of the core.
Non-linear fragmentation was defined as fragmentation that is out of plane from the core, creating uncertainty about which core it originated from.
Design
A study design was crafted to… utilize new technology to improve biopsy processing. Metrics targeted focused on cost, processing, slide evaluation, and diagnostic material quality/integrity.
Proposed Solution with New Technology
Biopsy Chip
BxChipTM Leavitt Medical Inc.
The proposed intervention was the use of a proprietary biomimetic matrix chip that can be…
Protocol
6 pairs only instead of 12 due to logistic issues
STANDARD
NEW
The first set of bx samples were transferred to 6 filter papers, then 6 formalin containers, as per the standard method. And the second set was inserted into 1 biopsy chip and then only 1 container for fixation.
STANDARD
NEW
Processing continued with embedding and sectioning. Standard processing included embedding 6 times, and sectioning 6 times. While the new method, involved embedding once and sectioning once.
STANDARD
NEW
And ultimately, the standard processing produced at least 18 slides in a typical case, with potential fragmentation. And the experimental method produced 3 slides, AND you can see intact cores separated by colored ridges on a single slide.
Balancing Measures
While conducting this study, there were several balancing measures taken into consideration. …For example, here you can see a smudging of the biomimetic matrix., which was not see in newer versions of the product.
Project Results (n = 48)
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An evaluation of outcomes strongly favored the new method. For the cost metric, our results showed a sig. decrease in cost in terms of materials, tech time, and IHC estimate, off setting the cost of the biopsy chip.
Project Results (n = 48)
1)For the Processing time metric, we saw a significant dec. across all parameters, including…
2)Finally, even though the linear fragmentation rate was the roughly the same, the chip processing method resulted in complete absence of non-linear fragmentation (the key parameter that leads to diagnostic errors) . We also saw a sig. inc. in tissue length.
IHC estimate: Cases with IHC on 2 or more blocks
Project Results
1)To summarize project outcomes, we reduced cost and processing time By processing 6 biopsies as 1 sample, which resulted in a >3 fold reduction in processing time.
2)The degree of fragmentation was reduced by eliminating specimen handling at collection, dissection, and embedding. Increasing the accuracy in determining %cancer involvement.
3)Additional benefits included an inc. in tissue length and decreased storage space.
Thank You