Clinical Studies
OralCDx: Oral dysplasia and carcinoma
Improving Detection of Precancerous and Cancerous Oral Lesions: Computer-Assisted Analysis of the Oral Brush Biopsy
JADA, Vol. 130, October 1999 1445-1457.
James J. Sciubba, DMD, Ph. D., Johns Hopkins University, for the U.S. Collaborative OralCDx Study Group
Background: A study group composed of researchers from across the United States undertook a study to evaluate the sensitivity and specificity of OralCDx (OralScan Laboratories Inc.), a computer-assisted method of analysis of the oral brush biopsy, in the detection of precancerous and cancerous lesions of the oral mucosa.
Methods: The study group conducted a multicenter double-blind study comparing results of OralCDx analysis with those of scalpel biopsy of suspicious oral lesions, as well as using OralCDx on oral lesions that appeared benign clinically.
Results: In 945 patients, OralCDx independently detected every case of histologically confirmed oral dysplasia and carcinoma (sensitivity= 100 percent, false-negative rate = 0 percent).Every OralCDx “positive” result was subsequently confirmed by histology as dysplasia or carcinoma. The specificity for the OralCDx “positive” result was 100 percent, while the specificity for the OralCDx “atypical” result was 92.9 percent. In 4.5 percent of clinically benign-appearing lesions that would not have received additional testing or attention other than clinical follow-up, OralCDx uncovered dysplasia or carcinoma (statistical sensitivity > 96 percent, P < .05, n = 131; statistical specificity for the OralCDx “positive” result > 97 percent and for the “atypical” result > 90 percent, P < .05, n = 196).
Conclusions: The authors propose that this multicenter trial demonstrates that OralCDx is a highly accurate method of detecting oral precancerous and cancerous lesions. OralCDx can aid in confirming the nature of apparently benign oral lesions and, more significantly, revealing those that are precancerous and cancerous when they are not clinically suspected of being so. All OralCDx “atypical” and “positive” results should be referred for scalpel biopsy and histology to completely characterize the lesion.
List and Summary of OralCDx Publications
Read List and Summary of OralCDx Publications >
An overview of clinical studies for OralCDx and CDx Technology in the oral cavity.
EndoCDx- Barrett’s Esophagus and Dysplasia
Computer-Assisted Brush-Biopsy Analysis for the Detection of Dysplasia in a High-Risk Barrett’s Esophagus Surveillance Population
Anandasabapathy S, Sontag S, Graham DY, Frist S, Bratton J, Harpaz N, Waye JD. Computer-Assisted Brush-Biopsy Analysis for the Detection of Dysplasia in a High-Risk Barrett's Esophagus Surveillance Population. Dig Dis Sci. 2011 Mar;56(3):761-6. Epub 2010 Oct 27.
Background: Background Barrett’s epithelial dysplasia, the direct precursor to esophageal adenocarcinoma, is often unapparent and frequently missed during surveillance of Barrett’s esophagus with four-quadrant forceps biopsy protocol. Aim To determine whether the detection of dysplasia is improved by adding computer-assisted brush biopsy (EndoCDx®) to four-quadrant biopsy protocol.
Methods: Patients with a history of Barrett’s esophagus with dysplasia scheduled for endoscopic surveillance were recruited from four academic medical centers. Patients underwent brush biopsy followed by four-quadrant biopsy every 1–2 cm. The results from brush and forceps biopsy were reviewed independently by pathologists blinded to the other’s results.
Results: Among 151 patients enrolled (124 men, 27 women; mean age: 65), 117 (77.5%) had forceps and brush-biopsy specimens adequate for interpretation. The mean number of forceps biopsies was 11.9 (median 10, range 2–40) and brush biopsies was 2.0 (median 2, range 1–4). The overall yield of forceps alone was 25.2% (n = 38). Brush biopsy added an additional 16 positive cases increasing the yield of dysplasia detection by 42% (95% CI: 20.7–72.7). The number needed to test (NNT) to detect one additional case of dysplasia was 9.4 (95% CI: 6.4–17.7). There were no significant differences in results among different centers, between standard versus jumbo forceps, or between forceps biopsies taken every 1 cm versus every 2 cm.
Conclusions: These data suggest that computer-assisted brush biopsy is a useful adjunct to standard endoscopic surveillance regimens for the identification of dysplasia in Barrett’s esophagus.
Computer-Assisted Analysis of Abrasive Transepithelial Brush Biopsies Increases the Effectiveness of Esophageal Screening:A Multicenter Prospective Clinical Trial by the EndoCDx Collaborative Group
Johanson JF, Frakes J, Eisen D; EndoCDx Collaborative Group. Computer-Assisted Analysis of Abrasive Transepithelial Brush Biopsies Increases the Effectiveness of Esophageal Screening: A Multicenter Prospective Clinical Trial by the EndoCDx Collaborative Group. Dig Dis Sci. 2011 Mar;56(3):767-72. Epub 2010 Dec 4.
Abstract: Background The sensitivity of screening for Barrett’s esophagus (BE) and esophageal dysplasia (ED) is hampered by the limited amount of tissue that can be sampled by forceps biopsy (FB).
Aim: The aim of this study was to evaluate computer assisted analysis of an abrasive, transepithelail brush biopsy as an adjunct to FB to increase detection of BE and ED. Methods This was a multicenter prospective trial of patients being screened for BE and ED. Each patient had two brush biopsies (BB) and then random four-quadrant FB every 1–2 cm of the esophagus. All BB were examined with computer assistance by pathologists at CDx Laboratories (Suffern, NY), and all FB were examined by the investigators’ local pathologists.
Results: Of 1,266 patients enrolled, 363 were diagnosed with BE by FB alone and 146 additional cases of BE were identified by adding BB. The addition of BB to FB increased the overall detection of BE by 39.8% (95% CI 32–48%). This added detection of BE in 11.5% of all patients tested with the BB (146/1266) resulted in a number of patients needed to test (NNT) to obtain each additional positive finding of Barrett’s esophagus of 8.7. Among a subset of 848 patients with gastroesophageal reflux disease and no prior history of BE, the addition of BB to FB identified an additional 105 patients with BE increasing the overall detection of BE by 70.5% (95% CI 54–90%). Dysplasia was diagnosed in 16 patients by FB alone, with an additional 14 cases detected by adding BB. The addition of BB to FB thus increased the detection of ED by 87.5%.
Conclusion: These results suggest that adjunctive computer-assisted analysis of an abrasive brush biopsy has the potential to substantially improve the detection of Barrett’s esophagus and dysplasia in screening populations.
EndoCDx: laryngeal dysplasia and carcinoma
Office-Based Laryngeal Procedures
Otolaryngol Clin N Am, 39 (2006) 111-133
Peak Woo, MD, FACS, Department of Otolaryngology, Mount Sinai School of Medicine, The Grabscheid Voice Center
Abstract: In a series of 24 patients, the author performed both brush biopsy and standard biopsies of the larynx in unsedated patients under local anesthesia with either flexible or rigid instrumentation. There were no complications such as hemoptysis, pneumonia or laryngospasm. All the samples were adequate in sampling of the basal layer of the epithelium. As there were no failures from the fiberoptic or the rigid brush techniques, the two different techniques done to perform the brush biopsy were equal in terms of sampling adequacy.
The positive predictive value of a ‘positive’ or ‘atypical’ brush biopsy for neoplasia or dysplasia was 84.2% in this series. The positive predictive value of a negative brush biopsy for benign conditions of the larynx was 87.5%.
It should be noted that brush biopsy is different than brush cytology in the larynx. Prior experience in using office brush cytology in the larynx was not successful due to: a) the failure to get adequate depth of tissue sampling of the basal layer, and b) inadequate sampling by the surgeon or cytologist in preparation and interpretation of the cytological sample. The EndoCDx brush biopsy system is different in that the brush has a sharp edge designed to sample the basal layer and the brush biopsy specimen is analyzed with the aid of a computer to assess all the cells collected.
The EndoCDx brush biopsy was easier to perform than a standard cup force biopsy of the larynx.
© 2011 CDx Diagnostics D/B/A Oral Cancer Prevention International, Inc.