What is PAULA’s Test?
PAULA’s Test is a blood test for lung cancer that measures cancer biomarkers which may be present in persons with lung cancer. Developed and run only by Genesys Biolabs, a “PAULA’s Test Score” indicates your risk for lung cancer at the time of testing.
Who are the candidates for this test?
National guidelines define exactly who is at high risk for getting lung cancer. PAULA’s Test follows the NCCN’s (National Comprehensive Cancer Network) definition of high risk, to help identify which persons should consider getting tested. High risk is defined by the following factors:
- Smokers and ex-smokers with 20 years of smoking an average of one pack of cigarettes per day or more
- 50+ years of age
- No current symptoms of lung cancer
- Not currently undergoing yearly CT scans for lung cancer
*Patients with a previous diagnosed cancer may have an elevated score despite the current absence of cancer.
HOW DOES PAULA’s TEST COMPARE WITH GETTING SCREENED WITH A CT SCAN?
Should I get a PAULA’s Test instead of getting a screening CT scan?
We do not recommend using PAULA’s Test if you qualify to receive free low dose CT scans. CT screening became a covered (free) service in 2015 for persons with high risk factors who met certain criteria. You should talk with your own doctor to see if screening with CT scans is an appropriate option for you. If you do not qualify for receiving a free screening CT scan, using PAULA’s Test may be an alternative option for you.
Why hasn’t my doctor heard about PAULA’s Test?
A number of reasons may contribute to why your doctor may not be aware of PAULA’s Test. In 2012, Genesys Biolabs began commercial testing after many years in development. As a small specialty testing lab that only runs one test, we do not employ a network of medical sales representatives as do larger pharmaceutical companies who call on doctors every day. If a national salesforce were used to market PAULA’s Test, the cost would be much higher and would likely be too expensive to be affordable as a elective test which is paid out-of-pocket.
New innovative diagnostic tests are become available every year. Your doctor may not be aware of PAULA’s Test since the use of biomarkers for detection of cancer only recently started to become common.
Is PAULA’s Test reimbursed by Insurance?
No, but Genesys Biolabs has made ordering PAULA’s Test as affordable as possible. National guidelines for testing and diagnosis of lung cancer do not yet recognize the use of tumor biomarkers as part of the standard screening regimen. Therefore, the use of such tests is not covered under insurance coverage policies. PAULA’s Test is an affordable elective test for persons who want to know their lung cancer risk. Elective tests require patients to pay out-of-pocket. Doctors may be hesitant to recommended non-covered elective tests for their patients which are not covered by insurance.
Should never-smokers get tested?
Persons who never smoked or who smoked for less than 20 years are not recommended to get tested. National guidelines which document lung cancer risk do not recommend persons who were exposed to secondhand smoke for screening. We therefore do not recommend PAULA’s Test for those who do not meet the criteria for high risk of developing lung cancer.
Why is it called “PAULA’s Test”?
“PAULA” is an acronym for “Protein Assay Using Lung cancer Analytes”. The test was named in memory of Paula Shore, the wife of Dr. Ron Shore, who succumbed to lung cancer in 2005. Paula Shore was a smoker early in her life but had quit smoking 20 years before she was diagnosed with lung cancer.
* American Cancer Society. Cancer Facts & Figures 2011. Atlanta: American Cancer Society; 2011