Genesys BioLabs, a business unit of 20/20 Genesystems, Inc., is dedicated to offering the most accurate and well validated biomarker based tests to aide in the early detection of lung cancer. Our laboratory is CLIA certified (ID# 21D2037411) and has state licensure from Maryland, Pennsylvania and Rhode Island. We are staffed by a team of Ph.D. and M.D. level scientists and a management group that collectively has more than 50 years of experience in the diagnostics industry.
20/20 GeneSystems (‘20/20’) was founded to develop and promote an innovative proteomics product line that provides drug companies, biodefense specialists and life scientists with new tools for protein analysis. Our headquarters are in the heart of the biotechnology corridor in Rockville, Maryland, in close proximity to the National Institutes of Health with which we have extensive collaborations.
PAULA’s Test is a serum protein biomarker test designed to discriminate risk of early-stage NSCLC in asymptomatic high-risk patients. Our unique approach combines high sensitivity tumor antigen biomarkers with high specificity autoantibodies in a multi-marker panel. These markers have been found to be detectable even in the earlies stages of disease development when intervention may leads to a cure.
PAULA's Test includes a panel of biomarkers associated with lung cancer. Four biomarkers, including a group of three tumor antigens and one tumor autoantibody, are included in the panel. Each tumor antigen in our test, both individually and as a panel, has been extensively studied by numerous investigators. The novelty of our test includes a proprietary scoring algorithm and methodology as well as the combination of testing at least one autoantibody with tumor antigens.
PAULA’s Test is used to detect non-small cell lung cancer which includes adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. Currently, PAULA's Test has 74% Sensitivity with 80% Sensitivity.
Patient blood samples are drawn into a standard SST (Tiger-top), spun at the draw facility (according to manufacturer specifications) and sent to our testing laboratory using the Genesys BioLabs Collection Kit. Collection Kits are provided free of charge to all of our customers and each contains a prepaid courier slip. All samples are tested in our CLIA certified lab in Rockville, Maryland (ID# 21D2037411). In addition to Maryland, we also have licenses from Rhode Island and Pennsylvania. The TAT for PAULA’s Test is 10 business days from time of receipt in the laboratory.
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Genesys BioLabs has not received any endorsements.