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What is LungSign™? What does it indicate?
What is the sputum collection procedure?
Who should take the test?
How does the patient prepare for the test?
How much does the test cost?
What if there is not enough sputum collected?
Where is the lab located?
How long will it take to get the results?
To whom will the result be reported?
Where has the test been approved?
What does the test measure?
How do I procure this test for my patients?
What if I still have questions after reviewing this website?
Questions and Answers
What is LungSign™? What does it indicate?
LungSign™ is a non-invasive lung cancer detection test that indicates
the likelihood of lung cancer in high risk individuals. It can detect
early-stage, pre-symptomatic lung cancer before it is discernable by
standard x-ray imaging.
LungSign™ is not meant to be used as a stand alone test for lung
cancer. It should be interpreted in conjunction with recognized diagnostic
procedures for the management of patients at risk of lung cancer or undergoing
post-surgical follow-up. Patients with lung malignancies may have low
scores. If a patient has relevant symptoms, further investigation is suggested.
What is the sputum collection procedure?
LungSign™ begins with the collection of sputum from the patient's
lungs and airways. This is accomplished by having the patient exhale
through a mucus clearance device which vibrates the airways with
low frequency sound waves, causing lung secretions to be expelled.
The specimen is sent to our laboratory where it is analyzed by the
LungSign™ automated image cytometer. The result is a single
lung cancer likelihood score derived from the measurements of thousands
of cell nuclei.
The unique strength of the LungSign™ Test is that it does not
rely strictly on the presence of cancerous cells to determine whether
or not a patient harbors lung cancer. The LungSign™ Sputum Test
primarily measures alterations to normal cells that occur in the presence of
a malignancy, a well-documented phenomenon known as Malignancy Associated
Changes ("MAC"). This approach overcomes the problem that cancer cells are
seldom present in sputum. Consequently, LungSign™ can assess the
likelihood of the presence of cancer from specimens which would not normally
yield useful results via other assays such as conventional cytology or
molecular marker based tests.
Who should take the test?
The test is for patients who are at high risk for developing lung cancer:
- Over 50 years old
- Significant exposure to cigarette smoke (one pack a day for 20
years or to industrial carcinogens
- Symptomology or clinical suspicion of lung cancer
The LungSign™ test has been developed primarily for people with a
higher propensity for developing lung cancer. This demographic consists
of people over the age of 50 with a significant history of smoking (i.e.
< 20 pack years), or significant industrial carcinogen exposure. This
however does not preclude people with a suspicious radiography, or with
symptoms such as persistent cough or shortness of breath, as potential
candidates for LungSign™.
Very few people find the induction of sputum from the lungs and airways
to be difficult, although there are some instances in which complications
can arise. Caution should be taken in situations where patients have severe
cardiovascular trouble, or a condition which may increase the likelihood
of bronchoconstriction (e.g., severe asthma).
The following patients should not take the test:
- those who have thoracic or cardiac surgery within the last 6 months.
- those with asthma or COPD (chronic obstructive lung disease)
exacerbation in the last five days
- those with flu-like symptoms such as fever or chills
How does the patient prepare for the test?
LungSign™ is a non-invasive and convenient test. All we request
is that patients refrain from eating for two hours, and if possible brush
their teeth prior to giving a sputum sample. .
How much does the test cost?
The LungSign™ test cost is CAD$175.00. The test is not currently
reimbursed by medical services plans in Canada and the EU.
What if there is not enough sputum collected?
Upon arrival at our laboratory each and every sputum sample is analyzed
for the presence of histiocytes, a cell type indicative of sputum produced
from deep within the lungs. Samples that do not contain histiocytes are not
analyzed, and an "insufficient sample" report will be sent to the patient's
physician. The mucus clearance device used in conjunction with the
LungSign™ test has been shown to provide adequate specimens when its
directions of use are followed correctly. It is the responsibility of the
patient to ensure that these directions are followed to ensure an adequate
sample. No refunds or retesting will be provided to those clients with an
"insufficient sample" result.
Where is the lab located?
All LungSign™ results are processed at our laboratory located in
Vancouver, Canada. At the present time, the laboratory has a provisional
accreditation from the Diagnostic Accreditation Program (DAP) of British
Columbia. The laboratory further intends to apply for accreditation with
the College of American Pathologist Laboratory Accreditation Program
(CAPLAP).
How long will it take to get the results?
It will take approximately two weeks for the sample to reach our lab,
be processed, and the result to be sent to the patient's physician.
To whom will the result be reported?
LungSign™ results are sent to the patient's doctor. The test
provides important information about the patient's risk of lung cancer.
This information needs to be interpreted in the context of their
medical history and their pretest risk for lung cancer. The patient's
physician is most capable of this interpretation, thus LungSign™
test results are sent directly to their doctor. This ensures that
the patient is properly counselled on the results of the test and
appropriate follow-up.
Where has the test been approved?
The LungSign™ test utilizes technology developed by Perceptronix
Medical Inc. in collaboration with the British Columbia Cancer Agency.
This technology has both a European CE Mark and Health Canada Approval.
At present, all tests originating from within North America are processed
at our Vancouver, Canada laboratory. In the future, LungSign™ tests
will be offered throughout the European Union through additional
laboratories established in member countries.
What does the test measure?
LungSign™ measures properties of the cell nuclei such as DNA
content, conformation and texture. Available nuclear information is
combined into a report for the specimen.
How do I procure this test for my patients?
LungSign™ tests can be purchased via the web at www.LungSign.com
under the tab "Order LungSign™ Now", or by phoning (888)-629-8779
and speaking with one of our customer service representatives.
What if I still have questions after reviewing this website?
All questions surrounding the LungSign™ test, including the
interpretation of results, should be placed to a customer service
representative at (888)-629-8779. The customer service representative
will put you in touch with the LungSign™ specialist that can
best answer your specific inquiry.
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