According to the American Cancer Society, symptoms of lung cancer usually do not appear until the disease is already advanced to late Stage III and IV, where treatments are less effective. Unfortunately, the lung cancer five-year survival rates (16.6%) are lower than many other cancers, such as colon (64.2%), breast (89.2%) and prostate (99.2%), because the early Stage that is more responsive to treatments goes undetected. The good news is that if caught in pre-symptomatic Stage I, the prognosis is significantly more encouraging.
Our LuCED® lung test is a non-invasive, take-home test prescribed by a physician to aid in the early detection of lung cancer. It requires a sputum sample (phlegm) from a deep cough three mornings in a row, using a simple test kit that we provide. The sputum sample is shipped to our CLIA laboratory, the VisionGate Biosignature Laboratories (VBL), and then processed on our proprietary Cell-CT™ system, a component of the LuCED test. This technology essentially allows your individual cells to be analyzed in high-resolution digital 3D for careful measurement of critical diagnostic features. The LuCED test classifies your cells as normal or abnormal. Our licensed cytologist screens the images and then our pathologist reviews the images and signs out the case as normal or abnormal. Those results are sent to the ordering physician in two to four weeks.
The LuCED test is not yet available to the public. It is a Laboratory Developed Test (LDT) that will be performed in our CLIA laboratory. In the meantime, please enter your name and email the form to the right so we can notify you as soon as it is launched through VBL.
Below are some Frequently Asked Questions:
What is the LuCED® lung test? What will my results mean?
The LuCED test is non-invasive test to aid physicians in the early detection of lung cancer. The test is based on sputum (phlegm from a deep cough). The test provides a “normal” or “abnormal” report to your physician. LuCED test results help physicians determine the next steps in the diagnosis and management of lung cancer.
Does the LuCED® test subject me to radiation?
No, absolutely no radiation is used in the LuCED test. Specimen collection can be performed at home and shipped in a pre-paid envelope to the VBL.
Will the test be covered by my health insurance?
LuCED is a new innovative test using proprietary technology. While there is a current insurance billing code to cover 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.
How will I collect the sputum sample at home?
Physicians can prescribe a sputum collection kit, which is taken home to collect samples over a three-day period. During these three days, you would produce a deep cough each morning in order to get contents from deep within your lungs (phlegm) instead of saliva from the oral cavity. Each sputum collection kit comes with collection and shipping instructions.
How long will it take to receive my test results?
Once your samples arrive at our lab, please allow 2 to 4 weeks for processing.
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 and where will I ship the sample?
A FedEx envelope and specific shipping instructions are included in each sputum collection kit. Once complete, you will ship your sample in a prepaid envelope to VisionGate Biosignature Laboratories, 275 N. GateWay Drive, Phoenix, AZ 85034.
What if there is not enough sputum collected?
We ask for three daily collections so you can produce an adequate sample. We require a thorough sample in order to run the test and encourage you to try to collect as much sputum as you can over the course of three mornings. If there are not enough cells to process, we will suggest alternatives for collection.
What if my physician is not familiar with the LuCED® test?
LuCED must be ordered through a physician. If your physician is not already familiar with LuCED, we are happy to provide materials to your physician and/or schedule an educational call or meeting with him or her.
Who can I contact for questions?
Please contact the VBL, open Monday through Friday, 8 a.m. to 5 p.m. at 602.354.8862.