Ikonisys Expects to Submit 4th FDA Clearance Application
Cancer Screening Device Described at ASCO
Indicates Breadth Of Medical Robotics Industry
By John J. Otrompke, JD
A medical robot manufactured by Ikonisys was described at this year’s annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
Ikonisys is expected to submit its 4th application for a clearance by the Food and Drug Administration (FDA) later this year.
The poster, and abstract 11084, was presented on June 1. While it was apparently the only research presented at ASCO concerning medical robotics, it illustrated the breadth and applicability of the robotics industry in medicine.
“Our developing system uses a robotic approach for magnifying slides with an efficiency and frequency sufficient to allow the detection of cancer cells with a frequency of as little as one in a million,” said Nicholas Romas, founder of Ikonisys, who presented the poster.
The robot works by using a process known as automated fluorescence microscopy, thereby avoiding complex purification procedures which risk cell loss and can create unresolved clusters of normal and cancer cells, according to the abstract, ‘Analysis of circulating tumor cells in prostate, colorectal and ovarian cancer using microscopy.’
In the study, blood samples were collected from seven prostate, ten colorectal and four ovarian cancer patients, as well as 11 healthy controls.
The device found the cells in all of the colorectal and ovarian patients, and five out of seven prostate cancer patients. There were no false positives, the abstract reported.
Since 2002, the Ikonisys system has received FDA approval for use of the device in detecting bladder cancer, as well as prenatal diagnosis of birth defects. The company also has submitted an application for breast cancer clearance, and expects to submit one for cervical cancer by the fall of this year.
Ikonisys currently has systems in place in Belgium and Switzerland, and Great Britain. The largest private lab in Italy, Centro Diagnostico Italiano, in Milan, also uses the Ikonisys system, said Romas, adding that more than 20 devices have been sold since the company began community placements less than a year ago.
The list price in the U.S. is $200,000, he added.
Indicates Breadth Of Medical Robotics Industry
By John J. Otrompke, JD
A medical robot manufactured by Ikonisys was described at this year’s annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
Ikonisys is expected to submit its 4th application for a clearance by the Food and Drug Administration (FDA) later this year.
The poster, and abstract 11084, was presented on June 1. While it was apparently the only research presented at ASCO concerning medical robotics, it illustrated the breadth and applicability of the robotics industry in medicine.
“Our developing system uses a robotic approach for magnifying slides with an efficiency and frequency sufficient to allow the detection of cancer cells with a frequency of as little as one in a million,” said Nicholas Romas, founder of Ikonisys, who presented the poster.
The robot works by using a process known as automated fluorescence microscopy, thereby avoiding complex purification procedures which risk cell loss and can create unresolved clusters of normal and cancer cells, according to the abstract, ‘Analysis of circulating tumor cells in prostate, colorectal and ovarian cancer using microscopy.’
In the study, blood samples were collected from seven prostate, ten colorectal and four ovarian cancer patients, as well as 11 healthy controls.
The device found the cells in all of the colorectal and ovarian patients, and five out of seven prostate cancer patients. There were no false positives, the abstract reported.
Since 2002, the Ikonisys system has received FDA approval for use of the device in detecting bladder cancer, as well as prenatal diagnosis of birth defects. The company also has submitted an application for breast cancer clearance, and expects to submit one for cervical cancer by the fall of this year.
Ikonisys currently has systems in place in Belgium and Switzerland, and Great Britain. The largest private lab in Italy, Centro Diagnostico Italiano, in Milan, also uses the Ikonisys system, said Romas, adding that more than 20 devices have been sold since the company began community placements less than a year ago.
The list price in the U.S. is $200,000, he added.
posted by John J. Otrompke | 12:53 PM
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