Before you purchase your test, there is some important information you  need to know.

Consent & Disclaimer for Consumers ordering PAULAs Test

You should carefully review all of the information provided by the laboratory offering the test (electronic or printed materials) including information about test intended use, performance, and limitations. Laboratory results from PAULAs test™ are for informational purposes only and are not a substitute for medical advice, diagnosis or treatment.   

GENERAL INFORMATION AND INTENDED USE

I understand the PAULAs test has not been approved by the U.S. Food & Drug Administration nor is it recommended as part of any screening guidelines by major medical organizations or authorities.

I understand that I am expected to pay laboratory in full at the time of test order.  Regardless of having Medicare or private health insurance,  I am aware that my insurance does not cover this service and I am fully responsible for payment at this time.

I understand that PAULAs Test is for persons with elevated risk factors for lung cancer and not intended for testing in the general population.

I understand that PAULAs test is NOT intended for persons currently exhibiting symptoms associated with lung cancer,  and should NOT be used to rule out lung cancer in persons with symptoms.    

I understand that PAULAs Test is not intended to discourage or replace current recommendations for lung cancer screening  by the US government (USPSTF) and as endorsed by organizations such as the American Lung Association and the American Cancer Society.

I acknowledge that I understand that lung cancer screening services may be available at no cost and that I may qualify under the eligibility rules as follows:

• in adults aged 55 to 80 years, and
• have a 30 pack-year smoking history, and
• either currently smoke or have quit within the past 15 years.

LIMITATIONS REGARDING ACCURACY

I understand that PAULAs Test is not 100% accurate, that there will be false positive and false negative results in some patients tested with PAULAs test,  and that the results of PAULAs Test cannot be guaranteed or relied upon as completely accurate.  

I also understand that results within the reference (normal) or “low” or “medium” risk range do not ensure absence of disease (know as a “false negative”). 

I understand that results that fall outside the reference range or “high risk” may indicate elevated risk of disease when not present (known as a “false positive”).

I understand that lab tests are not a substitute for a full medical evaluation. 

I will not hold 20/20 GeneSystems, Inc., (or its Genesys BioLabs business unit) its Officers, Directors, shareholders and employees, its affiliates, collaborators and agents, including the owners/operators of this facility, or its parent companies, their Officers, Directors and employees liable for any outcomes which may result from my participation in this testing option. 

RECEIVING RESULTS AND INTERPRETATION

Neither 20/20 GeneSystems, Inc. nor its employees, will interpret my test results for me. 

 It is my responsibility to consult a physician/healthcare provider for assistance in interpreting the results of this test and for diagnosing possible disease. 

I have requested that my results be mailed (convention or electronic) to me at the address provided and I retain all responsibility should someone else at that address access these results. 

I understand it is my responsibility to provide accurate contact information should I need to be reached in the event that critical values are reported. 

RESPONSIBILITY TO FOLLOW UP

I acknowledge it is my responsibility to contact a healthcare provider to review my results and determine if additional follow-up,  additional diagnostic testing and/or imaging is appropriate.

STEP 1. Create your account

Before you can order your test, we need you to create an account.

STEP 2. Select Products and Options

You can order one or more PAULA’s Test kits at the same time. You can also choose several optional services such as expedited shipping and additional collection kits and forms to be returned in the same return shipment, if more than one test will be sent at the same time.

Step 3. Confirm your order details

Step 4. Payment.