How does PAULA’s Test complement CT scans?

While chest CT is a highly sensitive test for lung cancer, it also has a very high false positive rate (96% from the National Lung Cancer Screening Trial) and exposes patients to a significant amount of radiation. PAULA’s Test is intended to aid risk assessment and early detection of lung cancer,  identifying patients who are at the highest risk among the high-risk patients to have a CT scan which will significantly reduce the number of false positive CT scans.

When should I use CT and when should I use PAULA’s Test?

Patients who are suspected of having lung cancer (i.e. symptomatic) should not have PAULA’s Test; rather, they should go directly to CT scan. PAULA’s Test is for the asymptomatic high-risk smoking population, who are not currently screened by LCDT. PAULA’s Test does not rule out the use of CT scan, but rather rules in its use for those patients with a test score indicating a high risk.

Why not use PAULA’s Test for all my patients?

PAULA’s Test has been developed and validated using samples from patients who are high-risk smokers (50 years or older, at least 20 pack-year smoking, and ex-smokers who quit no more than 15 years ago). Lung cancer has a low prevalence in the high-risk population (about 2%). While we do not have data on patients who are younger, who have smoked less, or who have been exposed only to second-hand smoke, we would expect an even lower prevalence of cancer and the risk score from PAULA’s Test would therefore not be applicable.

How do I interpret the PAULA’s Test score?

PAULA’s Test score corresponds to the risk of lung cancer in patients at the time of the test.

Is PAULA’s Test diagnostic for lung cancer?

PAULA’s Test is NOT a definitive diagnostic test for Lung Cancer. PAULA’s Test will aid risk assessment and early detection of lung cancer. It only indicates which patients should have a CT scan. A definitive diagnosis of lung cancer can only be made histologically or cytologically.

Is PAULA’s Test reimbursed by Medicare and private insurance?

Genesys Biolabs works with referring physicians to ensure full Medicare compliance and will file insurance claims on behalf of the patient. Individual payment plans are available.

Is PAULA’s Test available to be ordered through regional and national clinical reference labs like Labcorp or Quest?

Not at this time.  Tests should be sent directly to Genesys Biolabs.  An account can be set up with our lab at no cost to the practice.  We will send you supplies and requisition forms before you submit any tests.

How can I get set up to submit my patients’ samples?

Account setup instructions can be found here.

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