As you know, lung cancer is the most deadly cancer in the world, killing more than breast, prostate and colon cancers combined. However, if caught in pre-symptomatic Stage I, the prognosis is significantly more encouraging. Our mission at VisionGate is to have a positive impact and save lives using our LuCED® lung test to help find lung cancer at an early stage – when treatment options are more effective.
VisionGate will soon offer the LuCED test, which is being deployed as a Laboratory Developed Test (LDT) through our CLIA laboratory to aid physicians in early detection of lung cancer. The LuCED lung test requires a sputum sample that can be collected from spontaneous coughs over a three-day period using a take-home kit that the patient receives from your office.
LuCED test kits are shipped to the VisionGate Biosignature Laboratories (VBL) where samples are processed on our proprietary Cell-CT™ technology, a component of the LuCED test. The Cell-CT system is the world’s first automated 3D cell imaging platform that computes high-resolution biosignatures from intact cells. The LuCED test classifies the cells as normal or abnormal. Our licensed cytologists then screen the images followed by a review by our pathologist and a sign out of the case as normal or abnormal. Those results are sent to the ordering physician within two to four weeks.
VisionGate was founded by Dr. Alan Nelson, a physicist, bioengineer and entrepreneur who previously developed the world’s first automated screening test to detect cervical cancer, marketed today as the FocalPoint system by Becton Dickinson.
The LuCED lung test is not yet available to the public, but please enter your name and email in the form to the right and we’ll notify you as soon as it is! Or, please call 602.354.8862 to request a presentation on out LuCED test.
Below are some Frequently Asked Questions:
Who is at the highest risk for lung cancer?
What is the LuCED® lung test? What will the results mean?
The LuCED® lung test is a non-invasive test to aid physicians in the early detection of lung cancer. The VBL will generate a “normal” or “abnormal” report to you as the physician, which could help determine the next steps in the diagnosis of lung cancer.
Does the LuCED lung test subject patients to radiation?
No, absolutely no radiation is used in the LuCED test. The sputum sample can be collected at home and shipped to the VBL in Phoenix, Arizona.
What is the sputum collection process like for my patients?
The LuCED lung test requires a sputum sample that can be collected over three days using VisionGate’s take-home test kit that the patient receives from your office.
How long will it take to receive patient test results?
Once the patient’s sample arrives at VBL, please allow approximately 2 to 4 weeks for processing.
To whom will the results be reported?
VisionGate will send test results directly to the ordering physician. It is then the physician’s responsibility to discuss these results with the patient and determine next steps.
How do I obtain the test for my patients?
Do third-party payers cover the test?
LuCED is a new innovative test using proprietary technology. While there is a current CPT code for sputum cytology, many insurance companies have not yet established a formal coverage policy for LuCED. Any costs not covered by insurance will be the responsibility of the patient.
Is it a regulated test?
LuCED is a Laboratory Developed Test (LDT) that will be offered through the VBL, a CLIA laboratory. The Clinical Laboratory Improvement Amendments of 1998 (CLIA)
include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. CDC, in partnership with CMS and FDA, supports the CLIA program and clinical laboratory quality.
How do I request a presentation on the LuCED® test or ask additional questions not currently available on this website?
Please contact the VisionGate Biosignature Laboratories, open Monday through Friday, 8 a.m. to 5 p.m. at 602.354.8862.