The analytical validation and the certification of the test under Clinical Laboratory Improvement Amendments (CLIA-88) and International Organization for Standardization (ISO-15189) were completed in June 2016 and all the critical aspects of the test are controlled and supervised accordingly. Moreover, their
laboratories had in situ reviews by regulators in 2017 and 2018 with reaccreditation and satisfactory results.
The company has applied for patents and is expecting to have CE (European Conformity) marking and the International Organization for Standardization (ISO-13485) certification.
The company is expecting accreditation from the European Medicines Agency (EMA) for the use of its test in prostate cancer screening in 2019 and approval in the U.S. through the Food and Drug Administration (FDA) as an In Vitro Diagnostic (IVD) with similar pathway for lung cancer screening to commence in 2020.
They also offer testing services to physicians and individuals, researchers and corporations across many industries and regions, developing the adoption of telomeres and telomerase activity as key health biomarkers, advancing towards better and longer lifespans.
The company is seeking partners in the field of diagnostic oncology for prostate and lung cancer companies from the pharma, biotech /life sciences and nutraceutical companies -for in vitro and in vivo testing and studies- as well as personalized and preventive medicine companies.
The types of partnerships considered are financial agreements, joint venture agreements and services agreements.