XCLARIS

XCLARIS Onco Screening Test is a screening test focused primarily on the search for pathogenetic (VP) variants of the BRCA1 and BRCA2 genes. XCLARIS Onco Screening Test also offers the possibility of analyzing a wider panel of genes.

BRCA1 and BRCA2 are two genes involved in the mechanisms of maintaining genomic stability. Their job is to correct the errors generated in DNA during its duplication.

The test can be performed on a peripheral blood sample or on tumor tissue. The presence of alterations in the BRCA1 and BRCA2 genes is associated with an increased risk of developing tumors, especially of the ovary, breast, pancreas, prostate and Lynch syndrome, over the course of life. XCLARIS Onco Screening Test represents a valid tool to identify people who have a hereditary predisposition to the development of tumors in order to direct them to prevention programs (primary and / or secondary).

Yes. The finding of a pathogenetic variant in patients with ovarian, breast, pancreatic and prostate cancer BRCA1 / 2 also has therapeutic implications as it could predict the effectiveness of some chemotherapy treatments and PARP inhibitors.

XCLARIS Onco Screening Test is particularly indicated in:

• Familiarity for breast, ovarian, pancreatic or prostate cancer in three or more cases in the same family branch;
• patients with non-mucinous and non-borderline ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma;
• woman with breast cancer before the age of 36;
• woman with breast cancer and ovarian cancer;
• woman with triple negative breast cancer under the age of 60;
• woman with bilateral breast cancer less than 50 years old;
• male breast cancer;
• patients with metastatic pancreatic cancer;

XCLARIS Onco Screening Test offers various analysis panels, with different degrees of depth, as indicated in the following table

For the execution of a test, a suitable sample is needed from which to obtain an adequate amount of DNA. In the event that the suitability of the sample for analysis is verified (sample damaged or not sent correctly), the Laboratory will request a second sample. Each sample must be accompanied by the form containing the personal information necessary to process the report. The test uses first and second generation sequencing technologies.

The test can dare a "positive" outcome, that is, detect one or more variants of clear pathogenic significance for the genes investigated, or a "negative" outcome, that is, alter changes in benign clinical meaning or be "non-informative" in the event that variants are highlighted with uncertain and / or unknown clinical significance.

The technology used to perform the test uses CE-IVD certified materials (kits).