NEW YORK ─ Antegenes said on Wednesday that it has received CE marking for four polygenic risk score (PRS) tests ─ AnteBC for breast cancer, AntePC for prostate cancer, AnteCRC for colorectal cancer, and AnteMEL for melanoma.
The Estonia-based biotech company has launched the tests for use in the European Union and other countries that accept the designation.
The genetic tests assess a patient's personal cancer risks and include clinical recommendations for cancer prevention personalized for the patient, the firm said.
Antegenes' PRS tests are used to determine the number of single nucleotide polymorphisms that affect a patient's individual risk and produce a combined genetic risk assessment. The patient's personal risk is compared with the risk of the rest of the population and used with clinical recommendations to interpret the results. The tests evaluate the 10-year probability of developing the disease and the relative risk compared to the average genetic risk of the population, Antegenes said.
The AnteBC PRS combines 2803 SNPs, the AntePC PRS combines 121 SNPs, the AnteCRC PRS combines 91 SNPs, and the AnteMEL PRS combines 28 SNPs in an algorithm.
"Our products are meant for use in the healthcare system by a broad range of healthcare professionals and institutions," Antegenes CEO and Founder Peeter Padrik, said in a statement.
Antegenes' products are based on peer-reviewed international research and have been evaluated and validated using anonymous population data from the Estonian Biobank and UK Biobank.
All tests include clinical recommendations for early detection and prevention of diseases, the firm said, adding that its tests are the first CE-IVD marked breast cancer, prostate cancer, colorectal cancer, and melanoma polygenic risk score tests in the European Union.
Antegenes added that it is developing polygenic tests and models for cardiovascular disease and type 2 diabetes.