BRACAnalysis CDx

Proteins encoded by the BRCA1 and BRCA2 genes are involved in DNA damage repair. An inherited variant that disrupts the function of these genes may be associated with increased cancer risk and may be important in planning treatment for an already diagnosed cancer.

The test may give the doctor information about potential eligibility for PARP inhibitor treatment. Detecting a variant does not in itself promise that a particular medicine will be suitable or effective.

• Myriad: BRACAnalysis CDx patient information (USA)

Myriad’s European indications table lists the tumour–therapy associations shown below. The same biomarker condition applies to every row: deleterious or suspected deleterious BRCA1 or BRCA2 variants.

This is a summary of the source indications, not a personal treatment recommendation. The latest approved indications for the specific medicine and all of the patient’s clinical conditions must apply.

• Myriad Europe: BRACAnalysis CDx intended use and limitations

The test analyses genomic DNA from whole blood collected in an EDTA tube. It examines the protein-coding regions and intron/exon boundaries of BRCA1 and BRCA2.

Single nucleotide variants and small insertions or deletions are identified by PCR and Sanger sequencing; large deletions and duplications by multiplex PCR. The manufacturer’s form states that this CDx assay is for professional use and is performed at Myriad Genetic Laboratories.

• BRACAnalysis CDx request form (2022, English)

BRACAnalysis CDx detects inherited (germline) variants, not somatic variants arising only in the tumour. A negative blood result therefore does not rule out a somatic BRCA1 or BRCA2 change in tumour tissue.

This is especially important when considering treatment options for ovarian and prostate cancer. The doctor decides whether additional testing of tumour tissue is needed.

• Myriad Europe: BRACAnalysis CDx intended use and limitations

A doctor assesses whether the test is suitable and interprets the results. When enquiring, it is useful to have information about the diagnosis, tests already performed and planned treatment.

The manufacturer’s documents request details of the doctor, sample and clinical history and confirmation of the patient’s informed consent. Any previous bone marrow transplant or blood transfusion must be reported to the doctor so that the appropriate testing process can be arranged.

Before the sample is collected, agree the required documents, sample submission conditions, price and turnaround time with PharmaDNA.

• Official sample and request details

The intended use, methodology and limitations of the test are described in Myriad’s European information. Treatment selection must follow the current indications for the specific medicine and the individual clinical situation.

Additional links are labelled by region. Treatment, payment and testing arrangements described in the USA may differ from those applicable in Lithuania.

• Myriad Europe: intended use, indications and limitations
• Additional clinician information (USA)
• Additional patient information (USA)