by Thomas Dworetzky
, Contributing Reporter | February 10, 2016
At present in the U.S., if it looks like a patient may have basal-cell skin cancer, a biopsy is the standard procedure — but that may change soon.
Clinical trials in the U.S. have now shown that multi-beam Optical Coherence Tomography (‘OCT’) technology, may make diagnosis cut-free and immediate, according to English medical device company Michelson Diagnostics. In a multi-center study, its VivoSight OCT scanner, has been shown to significantly improve diagnosis of basal-cell carcinoma at an earlier stage and cut biopsies by 36 percent. The paper about this study appeared in the Journal of Clinical and Aesthetic Dermatology
“The data showed that VivoSight OCT improved diagnostic certainty for BCC by a factor of four over clinical examination alone, and improved diagnostic accuracy by 50 percent,” Dr. Orit Markowitz, Assistant Professor of Dermatology at the Icahn School of Medicine at Mount Sinai Hospital noted in a statement.
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“We also found that the addition of OCT to other standard assessments can improve the false-positive rate and give a high degree of certainty for ruling in a positive diagnosis for BCC. By sending these patients straight to surgery, we saw a 36 percent reduction in overall biopsies," he said.
OCT also showed better sensitivity and specificity than other standard approaches: it correctly diagnosed the cancer in 87.8 percent of cases vs. 57.4 percent for clinical and 69.6 percent for dermoscopy.
“This publication builds on existing excellent data showing that VivoSight scanning is emerging as a vital tool for the non-invasive diagnosis and monitoring of BCC and other non-melanoma skin cancers,” Michelson CEO Andy Hill noted.
The device is already for sale in Europe and has CE/TGA regulatory-clearance and FDA 510(k) clearance in the U.S.
Markowitz told NY1
that the device offers a distinct advantage over biopsy. "When we cut the skin out we only look at one tiny section. With this device it’s like we have 160 sections so it’s like a flipbook animation of sections. So we’re able to also see things that we wouldn’t even be able to see in pathology," he said.
Her team also uncovered 48 percent more basal cell carcinomas than with regular clinical exam. "In addition to preventing unnecessary cutting in cosmetically challenging areas, it’s also able to diagnose things substantially earlier in cosmetically challenging areas," she told the station.
According to Michelson, "given the unprecedented image resolution and image quality, VivoSight OCT has many potential clinical applications beyond the initial focus in dermatology."
Basal-cell skin cancer is most frequently diagnosed type of cancer, with 2.8 million cases in the U.S. in 2010, and its numbers continue to climb.