Diagnostic Tests

What Physicians Need to Know

PAULA's Test for Lung Cancer Screening

 

Am Fam Physician. 2020 Jul 1;102(1):53-54.

PAULA's test (Protein Assays Utilizing Lung Cancer Analytes) is a blood test for early detection of lung cancer in high-risk adults.1 Eligible patients are 50 years or older, current or former smokers with more than a 20-pack-year history and less than 15 years of smoking cessation, asymptomatic, and not being treated for lung cancer.2,3 The test is composed of a panel of three tumor markers (carcinoembryonic antigen, cancer antigen 125, and CYFRA 21-1 [a fragment of cytokeratin 19]) and one autoantibody marker (New York esophageal squamous cell carcinoma 1 [NY-ESO-1]).

 Enlarge     Print

TestIndicationPopulation, age range, and frequencyCost*

PAULA's test

Lung cancer screening

Adult patients at high risk of lung cancer†; testing frequency not yet established

$150 (plus shipping and any venipuncture fees charged by the medical office)


PAULA = Protein Assays Utilizing Lung Cancer Analytes.

*—Payment rate according to Genesys Biolabs.

†—Eligible patients are 50 years or older, current or former smokers with more than a 20-pack-year history and less than 15 years of smoking cessation, asymptomatic, and not being treated for lung cancer.2,3

TestIndicationPopulation, age range, and frequencyCost*

PAULA's test

Lung cancer screening

Adult patients at high risk of lung cancer†; testing frequency not yet established

$150 (plus shipping and any venipuncture fees charged by the medical office)


PAULA = Protein Assays Utilizing Lung Cancer Analytes.

*—Payment rate according to Genesys Biolabs.

†—Eligible patients are 50 years or older, current or former smokers with more than a 20-pack-year history and less than 15 years of smoking cessation, asymptomatic, and not being treated for lung cancer.2,3

Accuracy

A 2015 retrospective study used a training set of 115 patients with confirmed non–small cell lung carcinoma and 115 patients (matched in age and smoking history) in a control group to evaluate the predictive model used in PAULA's test.3 It was then validated in an independent set of 150 matched patients. This study found that the panel of four biomarkers was 77% sensitive and 80% specific for the detection of lung cancer in the validation group (positive likelihood ratio = 3.8; negative likelihood ratio = 0.29).3 Given a 1% likelihood of lung cancer in the target screening population, the positive predictive

Address correspondence to Karl T. Clebak, MD, FAAFP, at kclebak@pennstatehealth.psu.edu. Reprints are not available from the authors.

Author disclosure: No relevant financial affiliations.

References

show all references

1. PAULAs Test|2020 Gene Systems. Accessed May 21, 2020. https://2020gene.com/#PRODUCTS...

2. Genesys Biolabs. PAULA's test: is lung cancer screening right for you? Accessed May 2, 2019. https://bloodtestforlungcancer.com/wp-content/uploads/2017/09/Physician-Conversation-Guide-2017.pdf

3. Doseeva V, Colpitts T, Gao G, et al. Performance of a multiplexed dual analyte immunoassay for the early detection of non-small cell lung cancer. J Transl Med. 2015;13:55.

4. Mazzone PJ, Wang XF, Han X, et al. Evaluation of a serum lung cancer biomarker panel. Biomark Insights. 2018;13:1177271917751608.

5. U.S. Preventive Services Task Force. Final recommendation statement. Lung cancer: screening. September 25, 2014. Accessed May 5, 2019. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/lung-cancer-screening

6. Church TR, Black WC, Aberle DR, et al.; National Lung Screening Trial Research Team. Results of initial low-dose computed tomographic screening for lung cancer. N Engl J Med. 2013;368(21):1980–1991.

7. Healthcare Bluebook. Chest CT (no contrast). Accessed June 2, 2020 (zip code 66202). https://www.healthcarebluebook.com/ui/proceduredetails/138

This series is coordinated by Kenny Lin, MD, MPH, deputy editor.

A collection of Diagnostic Tests published in AFP is available at https://www.aafp.org/afp/diagnostic.

 

 

Copyright © 2020 by the American Academy of Family Physicians.
This content is owned by the AAFP. A person viewing it online may make one printout of the material and may use that printout only for his or her personal, non-commercial reference. This material may not otherwise be downloaded, copied, printed, stored, transmitted or reproduced in any medium, whether now known or later invented, except as authorized in writing by the AAFP. Contact afpserv@aafp.org for copyright questions and/or permission requests.

Want to use this article elsewhere? Get Permissions

CME Quiz

More in AFP

More in Pubmed

MOST RECENT ISSUE


Aug 1, 2020

Access the latest issue of American Family Physician

Read the Issue


Email Alerts

Don't miss a single issue. Sign up for the free AFP email table of contents.

Sign Up Now

Navigate this Article