415
Views
22
CrossRef citations to date
0
Altmetric
Articles

An update on the validation of whole slide imaging systems following FDA approval of a system for a routine pathology diagnostic service in the United States

Pages 381-389 | Accepted 11 Jul 2017, Published online: 24 Aug 2017

References

  • Aeffner F, Wilson K, Bolon B, Kanaly S, Mahrt CR, Rudmann D, Charles E, Young GD (2016) Commentary: roles for pathologists in a high-throughput image analysis team. Toxicol. Pathol. 44: 825–834.
  • Al-Janabi S, Huisman A, Nap M, Clarijs R, van Diest PJ (2012) Whole slide images as a platform for initial diagnostics in histopathology in a medium-sized routine laboratory. J. Clin. Pathol. 65: 1107–1111.
  • Bansal GJ (2006) Digital radiography. A comparison with modern conventional imaging. Postgrad. Med. J. 82: 425–428.
  • Bauer TW, Slaw RJ (2014) Validating whole-slide imaging for consultation diagnoses in surgical pathology. Arch. Pathol. Lab. Med. 138: 1459–1465.
  • Bauer TW, Schoenfield L, Slaw RJ, Yerian L, Sun Z, Henricks WH (2013) Validation of whole slide imaging for primary diagnosis in surgical pathology. Arch. Pathol. Lab. Med. 137: 518–524.
  • Bernard C, Chandrakanth SA, Cornell IS, Dalton J, Evans A, Garcia BM, Godin C, Godlewski M, Jansen GH, Kabani A, Louahlia S, Manning L, Maung R, Moore L, Philley J, Slatnik J, Srigley J, Thibault A, Picard DD, Cracower H, Tetu B (2014) Guidelines from the Canadian Association of Pathologists for establishing a telepathology service for anatomic pathology using whole-slide imaging. J. Pathol. Inform. 5: 15.
  • Bloom K, Harrington D (2004) Enhanced accuracy and reliability of HER-2/neu immunohistochemical scoring using digital microscopy. Am. J. Clin. Pathol. 121: 620–630.
  • Boyce BF (2015) Whole slide imaging: uses and limitations for surgical pathology and teaching. Biotech. & Histochem. 90: 321–330.
  • Brick KE, Sluzevich JC, Cappel MA, DiCaudo DJ, Comfere NI, Wieland CN (2013) Comparison of virtual microscopy and glass slide microscopy among dermatology residents during a simulated in-training examination. J. Cutan. Pathol. 40: 807–811.
  • Bruch LA, De Young BR, Kreiter CD, Haugen TH, Leaven TC, Dee FR (2009) Competency assessment of residents in surgical pathology using virtual microscopy. Hum. Pathol. 40: 1122–1128.
  • Campbell WS, Talmon GA, Foster KW, Baker JJ, Smith LM, Hinrichs SH (2015) Visual memory effects on intraoperator study design: determining a minimum time gap between case reviews to reduce recall bias. Am. J. Clin. Pathol. 143: 412–418.
  • Chetty R (2005) Statistics from Altmetric.com. J. Clin. Pathol. 58: 785.
  • Cornish TC, Swapp RE, Kaplan KJ (2012) Whole-slide imaging: routine pathologic diagnosis. Adv. Anat. Pathol. 19: 152–159.
  • Dee FR, Meyerholz DK (2007) Teaching medical pathology in the twenty-first century: virtual microscopy applications. J. Vet. Med. Educ. 34: 431–436.
  • Dennis J, Parsa R, Chau D, Koduru P, Peng Y, Fang Y, Sarode VR (2015) Quantification of human epidermal growth factor receptor 2 immunohistochemistry using the Ventana Image Analysis System: correlation with gene amplification by fluorescence in situ hybridization: the importance of instrument validation for achieving high (> 95%) concordance rate. Am. J. Surg. Pathol. 39: 624–631.
  • Elmore JG, Longton GM, Carney PA, Geller BM, Onega T, Tosteson AN, Nelson HD, Pepe MS, Allison KH, Schnitt SJ, O’Malley FP, Weaver DL (2015) Diagnostic concordance among pathologists interpreting breast biopsy specimens. J. Am. Med. Assoc. 313: 1122–1132.
  • Evans AJ, Chetty R, Clarke BA, Croul S, Ghazarian DM, Kiehl TR, Perez Ordonez B, Ilaalagan S, Asa SL (2009) Primary frozen section diagnosis by robotic microscopy and virtual slide telepathology: the University Health Network experience. Hum. Pathol. 40: 1070–1081.
  • Evans AJ, Kiehl TR, Croul S (2010) Frequently asked questions concerning the use of whole-slide imaging telepathology for neuropathology frozen sections. Semin. Diagn. Pathol. 27: 160–166.
  • Fallon MA, Wilbur DC, Prasad M (2010) Ovarian frozen section diagnosis: use of whole-slide imaging shows excellent correlation between virtual slide and original interpretations in a large series of cases. Arch. Pathol. Lab. Med. 134: 1020–1023.
  • FDA News Release (2017) FDA allows marketing of first whole slide imaging system for digital pathology; https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm552742.htm
  • Fine JL, Grzybicki DM, Silowash R, Ho J, Gilbertson JR, Anthony L, Wilson R, Parwani AV, Bastacky SI, Epstein JI, Jukic DM (2008) Evaluation of whole slide image immunohistochemistry interpretation in challenging prostate needle biopsies. Hum. Pathol. 39: 564–572.
  • Ford JC, Pinder KE, Ovalle WK, Li CH (2008) Pathology education in a multisite urban/rural distributed curriculum. Hum. Pathol. 39: 811–816.
  • Frierson HF Jr, Galgano MT (2007) Frozen-section diagnosis by wireless telepathology and ultra portable computer: use in pathology resident/faculty consultation. Hum. Pathol. 38: 1330–1334.
  • Gilbertson JR, Ho J, Anthony L, Jukic DM, Yagi Y, Parwani AV (2006) Primary histologic diagnosis using automated whole slide imaging: a validation study. BMC Clin. Pathol. 6: 4.
  • Goacher E, Randell R, Williams B, Treanor D (2017) The diagnostic concordance of whole slide imaging and light microscopy: a systematic review. Arch. Pathol. Lab. Med. 141: 151–161.
  • Grady D (2015) Breast biopsies leave room for doubt, study finds. New York Times, 03/17/2015, https://www.nytimes.com/2015/03/18/health/breast-biopsies-dcis-atypia-diagnosis-leave-room-for-doubt.html?
  • Graham AR, Bhattacharyya AK, Scott KM, Lian F, Grasso LL, Richter LC, Carpenter JB, Chiang S, Henderson JT, Lopez AM, Barker GP, Weinstein RS (2009) Virtual slide telepathology for an academic teaching hospital surgical pathology quality assurance program. Hum. Pathol. 40: 1129–1136.
  • Griffin J, Treanor D (2017) Digital pathology in clinical use: where are we now and what is holding us back? Histopathology 70: 134–145.
  • Hamilton PW, Wang Y, Boyd C, James JA, Loughrey MB, Hougton JP, Boyle DP, Kelly P, Maxwell P, McCleary D, Diamond J, McArt DG, Tunstall J, Bankhead P, Salto-Tellez M (2015) Automated tumor analysis for molecular profiling in lung cancer. Oncotarget 6: 27938–27952.
  • Hitchcock CL (2011) The future of telepathology for the developing world. Arch. Pathol. Lab. Med. 135: 211–214.
  • Ho J, Ahlers SM, Stratman C, Aridor O, Pantanowitz L, Fine JL, Kuzmishin JA, Montalto MC, Parwani AV (2014) Can digital pathology result in cost savings? A financial projection for digital pathology implementation at a large integrated health care organization. J. Pathol. Inform. 5: 33.
  • Horn AJ, Czarnecki D, Lele SM (2012) Interactive case vignettes utilizing simulated pathologist-clinician encounters with whole slide imaging and video tutorials of whole slide scans improves student understanding of disease processes. J. Pathol. Inform. 3: 34.
  • Isaacs M, Lennerz JK, Yates S, Clermont W, Rossi J, Pfeifer JD (2011) Implementation of whole slide imaging in surgical pathology: a value added approach. J. Pathol. Inform. 2: 39.
  • Jara-Lazaro AR, Thamboo TP, Teh M, Tan PH (2010) Digital pathology: exploring its applications in diagnostic surgical pathology practice. Pathology 42: 512–518.
  • Jones NC, Nazarian RM, Duncan LM, Kamionek M, Lauwers GY, Tambouret RH, Wu CL, Nielsen GP, Brachtel EF, Mark EJ, Sadow PM, Grabbe JP, Wilbur DC (2015) Interinstitutional whole slide imaging teleconsultation service development: assessment using internal training and clinical consultation cases. Arch. Pathol. Lab. Med. 139: 627–635.
  • Kumar RK, Velan GM, Korell SO, Kandara M, Dee FR, Wakefield D (2004) Virtual microscopy for learning and assessment in pathology. J. Pathol. 204: 613–618.
  • Laurinavicius A, Laurinaviciene A, Dasevicius D, Elie N, Plancoulaine B, Bor C, Herlin P (2012) Digital image analysis in pathology: benefits and obligation. Anal. Cell. Pathol. (Amst.) 35: 75–78.
  • Mackinnon AD, Billington RA, Adam EJ, Dundas DD, Patel U (2008) Picture archiving and communication systems lead to sustained improvements in reporting times and productivity: results of a 5-year audit. Clin. Radiol. 63: 796–804.
  • Marsch AF, Espiritu B, Groth J, Hutchens KA (2014) The effectiveness of annotated (vs. non-annotated) digital pathology slides as a teaching tool during dermatology and pathology residencies. J. Cutan. Pathol. 41: 513–518.
  • Nitrosi A, Borasi G, Nicoli F, Modigliani G, Botti A, Bertolini M, Notari P (2007) A filmless radiology department in a full digital regional hospital: quantitative evaluation of the increased quality and efficiency. J. Digit. Imaging 20: 140–148.
  • Pantanowitz L, Valenstein PN, Evans AJ, Kaplan KJ, Pfeifer JD, Wilbur DC, Collins LC, Colgan TJ (2011) Review of the current state of whole slide imaging in pathology. J. Pathol. Inform. 2: 36.
  • Pantanowitz L, Wiley CA, Demetris A, Lesniak A, Ahmed I, Cable W, Contis L, Parwani AV (2012) Experience with multimodality telepathology at the University of Pittsburgh Medical Center. J. Pathol. Inform. 3: 45.
  • Pantanowitz L, Sinard JH, Henricks WH, Fatheree LA, Carter AB, Contis L, Beckwith BA, Evans AJ, Lal A, Parwani AV (2013) Validating whole slide imaging for diagnostic purposes in pathology: guideline from the College of American Pathologists Pathology and Laboratory Quality Center. Arch. Pathol. Lab. Med. 137: 1710–1722.
  • Port E (2015) Rita Wilson’s “excellent” advice on breast cancer, second opinions. CBS News.com, 04/15/2015, Available from: http://www.cbsnews.com/news/rita-wilson-cancer-diagnosis-importance-second-opinion.
  • Raab SS, Grzybicki DM, Mahood LK, Parwani AV, Kuan SF, Rao UN (2008) Effectiveness of random and focused review in detecting surgical pathology error. Am. J. Clin. Pathol. 130: 905–912.
  • Randell R, Ruddle RA, Mello-Thoms C, Thomas RG, Quirke P, Treanor D (2013) Virtual reality microscope versus conventional microscope regarding time to diagnosis: an experimental study. Histopathology 62: 351–358.
  • Rice S (2016) Put it on the Board. FDA open to whole-slide imaging as Class II device. CAP Today 86.
  • Robboy SJ, Weintraub S, Horvath AE, Jensen BW, Alexander CB, Fody EP, Crawford JM, Clark JR, Cantor-Weinberg J, Joshi MG, Cohen MB, Prystowsky MB, Bean SM, Gupta S, Powell SZ, Speights VO Jr, Gross DJ, Black-Schaffer WS (2013) Pathologist workforce in the United States. I. development of a predictive model to examine factors influencing supply. Arch. Pathol. Lab. Med. 137: 1723–1732.
  • Romero Lauro G, Cable W, Lesniak A, Tseytlin E, McHugh J, Parwani A, Pantanowitz L (2013) Digital pathology consultations-a new era in digital imaging, challenges and practical applications. J. Digit. Imag. 26: 668–677.
  • Smits AJ, Kummer JA, de Bruin PC, Bol M, van den Tweel JG, Seldenrijk KA, Willems SM, Offerhaus GJ, de Weger RA, van Diest PJ, Vink A (2014) The estimation of tumor cell percentage for molecular testing by pathologists is not accurate. Mod. Pathol. 27: 168–174.
  • Snead DR, Tsang YW, Meskiri A, Kimani PK, Crossman R, Rajpoot NM, Blessing E, Chen K, Gopalakrishnan K, Matthews P, Momtahan N, Read-Jones S, Sah S, Simmons E, Sinha B, Suortamo S, Yeo Y, El Daly H, Cree IA (2016) Validation of digital pathology imaging for primary histopathological diagnosis. Histopathology 68: 1063–1072.
  • Stalhammar G, Fuentes Martinez N, Lippert M, Tobin NP, Molholm I, Kis L, Rosin G, Rantalainen M, Pedersen L, Bergh J, Grunkin M, Hartman J (2016) Digital image analysis outperforms manual biomarker assessment in breast cancer. Mod. Pathol. 29: 318–329.
  • Stathonikos N, Veta M, Huisman A, van Diest PJ (2013) Going fully digital: perspective of a Dutch academic pathology lab. J. Pathol. Inform. 4: 15.
  • Thorstenson S, Molin J, Lundstrom C (2014) Implementation of large-scale routine diagnostics using whole slide imaging in Sweden: digital pathology experiences 2006–2013. J. Pathol. Inform. 5: 14.
  • Treanor D (2009) Virtual slides: an introduction. Diagn. Histopathol. 15: 99–103.
  • Wack K, Drogowski L, Treloar M, Evans A, Ho J, Parwani A, Montalto MC (2016) A multisite validation of whole slide imaging for primary diagnosis using standardized data collection and analysis. J. Pathol. Inform. 7: 49.
  • Ward MFC (2016) DPA recommends whole slide imaging manufacturers submit de novo applications to the FDA for primary diagnosis in the United States. Available at: http://www.prweb.com/releases/2016/01/prweb13163307.htm.
  • Webster JD, Dunstan RW (2014) Whole-slide imaging and automated image analysis: considerations and opportunities in the practice of pathology. Vet. Pathol. 51: 211–223.
  • Wilbur DC, Madi K, Colvin RB, Duncan LM, Faquin WC, Ferry JA, Frosch MP, Houser SL, Kradin RL, Lauwers GY, Louis DN, Mark EJ, Mino-Kenudson M, Misdraji J, Nielsen GP, Pitman MB, Rosenberg AE, Smith RN, Sohani AR, Stone JR, Tambouret RH, Wu CL, Young RH, Zembowicz A, Klietmann W (2009) Whole-slide imaging digital pathology as a platform for teleconsultation: a pilot study using paired subspecialist correlations. Arch. Pathol. Lab. Med. 133: 1949–1953.
  • Wiley CA, Murdoch G, Parwani A, Cudahy T, Wilson D, Payner T, Springer K, Lewis T (2011) Interinstitutional and interstate teleneuropathology. J. Pathol. Inform. 2: 21.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.