lung-cancer1

 

HOW TO ORDER PAULA’S TEST FOR MY PATIENTS

You must set up an account prior to submitting test samples. There is no fee to set up an account. Account setup instructions can be found here.

Account Setup

We provide requisition forms, collection kits (Styrofoam cooler, ice packs and test tubes) and prepaid shipping labels.

A standard venous blood sample must be collected from the patient.  A single SST (serum separator tube, “tiger top”) is collected and spun.

A requisition form must be filled out for the patient and signed by the ordering physician (see a sample requisition form).

The sample can be sent via FedEx. Offices in the greater Washington DC metropolitan area can also call for a local courier pickup.

Shipping costs are paid by Genesys Biolabs.

HOW RESULTS ARE REPORTED

The test score will help determine the risk that a patient currently has lung cancer. Patients can then be directed to the appropriate diagnostic follow up. Yearly serial testing for lung cancer gives the physician the best chance of detecting lung cancer early in at-risk patients. With regular testing physicians can triage high-risk patients to CT before symptoms present. When used in conjunction with PAULA’s Test, these imaging tests will generate fewer false positives. See a blank sample report.

INTERPRETING RESULTS

A low risk score on PAULA’s test is a strong indicator that the patient does not have cancer (99.3 percent of patients with a score 6.4 or below do not have cancer). Based on the prevalence of lung cancer (2%) in the high risk population, approximately 20 at-risk patients would be found to have lung cancer among a population of 1000 individuals. If all of these individuals receive PAULA’s test, about 215 will score in high risk category. If all of them are referred to low-dose CT, one can expect 15 out of 20 cancers to be detected.

It is important to note that we do not report a “positive” or “negative” for lung cancer but instead categorize patients based on their likelihood of having lung cancer at the time of the test.  That way physicians that see many current or ex-smokers can make sure that at least patients identified as having an elevated risk are followed up with radiographic screening.

The sensitivity of PAULA’s test is 74% when the specificity is set at 80%. For example, in a group of 1000 asymptomatic high-risk patients, about 2% (20) will have lung cancer. Of that group, about 15 will test positive for PAULA’s Test and about 200 of the patients without lung cancer will also test positive.

Evidence Supporting the Accuracy and Validity of PAULA’s Test

PAULA’s Test has been developed and tested using blood samples from over 1,800 different patients including:

  • Patients from 6 different regions of the US.
  • Age-matched control patients (heavy smokers, individuals with other non-cancerous lung disorders, and other types of cancers)
  • Analyzed by an independent group of biostatisticians
  • Each biomarker in our panel has been independently reported in numerous peer reviewed publications to be associated with lung cancer; several groupings of these biomarkers have also been independently studied and reported in the literature
  • Elevated test scores correlate with the presence of disease.

PAULA’s Test is a laboratory developed test that is performed in a certified laboratory in accordance with the Clinical Laboratory Improvement Act (CLIA) of 1988.

For more details download technical paper.