Phenogen Sciences Laboratories (PSL) is the U.S. division of Australian-based Genetic Technologies Limited (GTG). The company was established in 2010 as a global expansion strategy of GTG’s oncology and cancer management diagnostics division. As a pioneer in personalized healthcare, PSL offers its flagship test, BREVAGenplus. BREVAGenplus is a first in class, scientifically validated test that combines genetic markers and clinical risk factors to assess a woman’s personal risk of developing non-hereditary breast cancer. The result of this test helps healthcare providers proactively manage the breast health of their patients.
Genetic Technologies Limited (NASDAQ: GENE) is based in Melbourne, Australia. For more than 20 years, the company has provided laboratory services in molecular diagnostics and was an early pioneer in recognizing important new applications for ‘non-coding’ DNA. The company has since been granted patents in 24 countries around the world, and has serviced a range of geographic territories including the U.S., Australia, Pacific Rim and Europe.
Our laboratory at 60-66 Hanover Street, Fitzroy, Melbourne, Australia
About the Lab
PSL operates under Clinical Laboratory Improvement Amendments (CLIA) and Clinical Laboratory Evaluation Program (CLEP). GTG has participated in Quality Assurance Programs that have included the College of American Pathology (CAP), Collaborative Testing Services Forensics Testing Program and the European Molecular Genetics Quality Network (EMQN) for the past 20 years.
The laboratory is highly automated and uses precision liquid handling robotics, instruments and software to ensure efficient turn around times. All instruments and software have been validated and implemented to assist with high throughput of various different sample types received. Our team consists of highly qualified, experienced and dedicated staff. All clinical scientists have their credentials assessed by the International Education Research Foundation in California and are issued with a U.S. equivalency report for their qualifications before they begin testing samples.
A unique barcode is issued to each patient sample when it arrives at our office in Charlotte, NC. This enables us to track the progress of each sample from the time it arrives in Charlotte, through delivery to Australia, to the time the report is issued back to the healthcare provider. Our Laboratory Information Management System (LIMS) is integrated with all laboratory instruments and ensures that we provide ‘the right test, with the right results, for the right patient, at the right time’.
Laboratory offices in our modern well designed building
Lab sample throughput
At PSL, test samples are processed on a daily basis. Our automated laboratory has allowed us to streamline sample possessing with no capacity constraints, and in turn is able to manage larger sample volumes in an efficient amount of time.
Each patient sample is processed through our LIMS system and assigned a unique internal barcode. All of our results are completely automated, and are exported from the analysis software and uploaded into LIMS.
PSL has full audit tracking. We track every action and test performed on a sample. This allows us to then produce a comprehensive “continuity “ report on any sample which details where that test sample has been, what has been done to it and who the examiners/analysts were.
Placing samples on a liquid handling robot
- BREVAGenplus provides information about breast cancer risk; it does not diagnose breast cancer
- BREVAGenplus is validated in African American, Caucasian, and Hispanic women age 35 years or older
- The risk estimate used in this test does not take into account several other breast cancer risk factors, such as an extensive family history of breast and ovarian cancer
- This test is used for clinical purposes
* BREVAGenplus is not applicable to women who have a personal or extensive family history of breast and/or ovarian cancer, or other high risk factors. In this case, patients would be referred for genetic counseling and risk assessment for hereditary cancers