Lung Cancer
Lung cancer is the leading cause of cancer deaths in women and men both in the United States and throughout the world. Lung cancer has surpassed breast cancer as the leading cause of cancer deaths in women. In the United States alone over 159,000 people are projected to die from lung cancer in 2010, which is more than the number of deaths from colon and rectal, breast and prostate cancer combined.
According to the National Cancer Institute, 86% of all people diagnosed with lung cancer die within 5 years with only about 2% surviving if diagnosed with lung cancer that has spread to other areas of the body.
However, the survival rates for lung cancers diagnosed at the earliest stage are higher with 49% surviving for five years or longer. Early detection is the key to survivability for most cancers but even more so for lung cancer due to the large number of individuals and families impacted by this devastating disease.
Provista has developed a simple blood test for the early detection of lung cancer called the "LC Sentinel™ Test. LC Sentinel™ clinical demonstrated a sensitivity of 87%, specificity of 95% and an ROC accuracy of 0.97 for the detection of lung cancer in a combined study of men and women.
This test will be released to the general public in the next few months as a CLIA Laboratory Developed Test (LDT). For individuals and practitioners interested in finding out more details about LC Sentinel™ and its date of availability, please contact Provista's Customer Service Department.
LC Sentinel™
Lung Cancer accounts for more deaths than any other cancer in both men and women. According to the National Cancer Institute (NCI), approximately 157,300 deaths occur each year and lung cancer accounts for about 28% of all cancer deaths. More women die of lung cancer than breast cancer.
The NCI also states that the risk factors for developing lung cancer include cigarette smoking, and occupational exposure to chemicals, mining of coal and asbestos, environmental exposure to radon, particulates, secondhand smoke, metals like arsenic, cadmium and chromium and general air pollution. About 90% of all lung cancer cases are related to current or former tobacco smokers. Lung Cancer can occur at any age, but, in general, the incidence rate increases with age.
According to the Surveillance Epidemiology and End Results Study, the overall 5-year relative survival rate for lung cancer is 15.8%. This long-term study is an ongoing joint effort of the NCI and the American College of Radiology. However, this overall rate is skewed by the survival rate for early stage detected lung cancers with a 52.9% 5-year survival rate. The table below from SEER shows that impact.
As can easily be seen from the data above the 5-year survival rate drops dramatically from detection at an early stage (localized) to the regional stage and onto the distant stage when most lung cancers (56%) are currently diagnosed.
According to the American Cancer Society, screening for lung cancer with current methods has not yet proven to reduce mortality. Detection by chest x-ray, analysis of cells in sputum and even fiber optic examination of the bronchial passages has shown limited effectiveness in reducing lung cancer deaths. Newer tests, such as low dose spiral computed tomography (CT) scans and molecular markers in blood and sputum have produced promising results in detecting lung cancer at earlier stages when it is more operable. However, CT scans are quite expensive and do not make practical screening methods.
A typical screening chest x-ray uses 2 views of the lungs -- a frontal view and a side view. The average cost of this x-ray screening procedure using just a single frontal view is $80 at an Urgent Care facility and $274 at a hospital as an outpatient. The single frontal view has been shown to detect 52% to 69% of the lung cancers with a lesion ranging from 6.8 mm to 50.7 mm. This would be in the “regional” stage where the survival rate is 24%. The addition of a follow-up CT scan does not significantly improve earlier detection even at the expense of a high false-positive rate. CT Scans were shown to be strongly observer dependent.
Given that cigarette smoking is the cause of 90% of all lung cancers, the population at risk is every smoker or every former smoker over 40 years of age. By age group, the prevalence of smoking was lowest among those aged 65 years or older (8.3%), compared with those aged under 65 years (persons aged 18--24 years [22.2%], aged 25--44 years [22.8%], and aged 45--64 years [21.0%]).
At $150 per LC Sentinel™ Test that represents a total market for the laboratory of nearly $1.5 billion per year for the U.S. alone. Earlier detection will save thousands of lives each year and reduce the cost for treatment of lung cancer by billions of dollars.
Clinical Study
 Provista's study completed the requisite analyses and data evaluation needed to validate the LC Sentinel™ Test, which successfully detects lung cancer with a high degree of accuracy. The study included men and women between 20-76 years of age. The data generated in this final study proved consistent with previous findings and produced positive clinical performance marks of 87% sensitivity; 95% specificity; and an ROC Accuracy of 97%. By industry standards the study proved very successful and will serve as the cornerstone to Provista’s efforts to introduce the new lung cancer diagnostic to market. Provista intends to introduce LC Sentinel™ as a CLIA Laboratory Developed Test (LDT) for use in high-risk lung cancer patient populations in the U.S. during the third quarter 2011 through its standard clinical channels that include physicians, medical clinics and hospitals.
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