PROFESSIONAL

ACTBRCA® / ACTBRCA® HRD

Evaluate PARP Inhibitors with Precision

Studies have shown that mutations in BRCA1/2 and homologous recombination repair (HRR) genes can confer sensitivity to PARP inhibitors1, 2, 3, 4. Using ACTBRCA® / ACTBRCA® HRD genetic tests to detect mutations in BRCA1/2 and other HRR associated genes can provide genetic information for physicians to evaluate if the patient's tumor is suitable for PARP inhibitors.

- There are currently 4 PARP inhibitors approved by the US FDA for BRCA1/2-mutated ovarian cancer and BRCA1/2-mutated, HER2-negative metastatic breast cancer patients’ management, each with different clinical indications.

- Phase III ARIEL3 study showed that Rucaparib as a maintenance treatment improved PFS in high-grade ovarian cancer patients, with either mutations in BRCA1/2 or HRR associated genes5:

•BRCA1/2 mutated cohort, HR = 0.23

•Non-BRCA1/2 HRR mutated cohort, HR = 0.21


Identify More Patients for PARP Inhibitors

ACTBRCA® / ACTBRCA® HRD can provide more comprehensive genetic information than common BRCA tests. In addition to germline BRCA mutations, our tests can also detect BRCA germline large genomic rearrangement (LGR), BRCA somatic mutations in tumor samples, and other HRR related mutations, allowing physicians to identify more patients suitable for PARP inhibitors.

 

Ovarian Cancer Mutation Frequency
ACTBRCA


References:

1. Venkitaraman AR. Annu Rev Pathol 2009; 4: 461-487.

2. Lord CJ. et al. Nat Rev Cancer. 2016 Feb;16(2):110-20.

3. Turner N. et al. Nat Rev Cancer. 2004;4(10):814–819.

4. Lord CJ. et al. Science. 2017 Mar 17;355(6330):1152-1158.

5. O'Malley DM. et al. Mol Cancer Ther 2018;17(1 Suppl): Abstract nr LB-A12.

6. da Cunha Colombo Bonadio RR. et al. Clinics (Sao Paulo). 2018 Aug 20;73(suppl 1):e450s.

7. Yazıcı H. et al. Eur J Breast Health. 2018 Apr 1;14(2):93-99.

ACTBRCA® / ACTBRCA® HRD Advantages

1. Identifying patients for PARP inhibitors via germline and somatic mutations

- ACTBRCA® (Blood Samples): detects BRCA1/2 germline mutations

- ACTBRCA® (Blood + Tissue Samples): detects BRCA1/2 germline and somatic mutations

- ACTBRCA® HRD(Blood + Tissue Samples): sequences 48 DNA repair genes including BRCA1/2; detects both germline and somatic mutations.

2. Complete coverage and detection of multiple mutation types

Includes entire coding exons and splicing regions of BRCA1/2. Next-generation sequencing (NGS) is used to detect multiple mutation types:

- Single nucleotide variants (SNV)

- Small insertions and deletions (Small InDels)

- Large genomics rearrangements (LGRs)

3. Clinically-relevant and insightful interpretation

Experienced in-house informatics team to provide clinically-relevant and insightful interpretation, referencing both international databases and ACT Genomics internal database.

- ClinVar Database: ClinVar (Clinical Significance for Variants Relative to Phenotypes) database maintained by the National Center for Biotechnology Information (NCBI).

- ACTBRCA (ACT Genomics Internal Database): ACT Genomics initiated the first “BRCA 100 Project” in Taiwan to test 100 ovarian cancer patients with ACTBRCA. Results show as many as 12% of the ovarian cancer patients carry BRCA1/2 mutations, and 25% of serous ovarian cancer patients carry BRCA1/2 mutations. These collected results will facilitate the accuracy of the ACTBRCA tests.

4. Report consultation

Every report is complemented with one-on-one consultation with our medical team.

5. Short turnaround time: 14 calendar days

ACTBRCA® / ACTBRCA® HRD

Who is Suitable?

  1. Ovarian cancer patients and breast cancer patients

  2. Other solid tumor patients who wish to use PARP inhibitors

Specifications


NGS Sequencing

ACTBRCA

2 genes (BRCA1/2)


ACTBRCA HRD

48 genes (including BRCA1/2)

Sensitivity

ACTBRCA

96.7%


ACTBRCA HRD

99.7%

Specificity

ACTBRCA

100%


ACTBRCA HRD

100%

Mutation Types (Sample Req.)

ACTBRCA

Germline (Blood)

Germline & Somatic (Blood + Tissue)

ACTBRCA HRD

Germline & Somatic (Blood + Tissue)

Sequencing Mean Depth

>500 x