■ What is SOFIVA HRD Status?

SOFIVA HRD Status is a genetic testing that assists physician in identifying suitable patients that would benefit from PARP inhibitor treatment.

The testing items of this NGS-based testing are:
1. 28 HRR genes, including BRCA1/2
2. Genome Integrity Index (GII)

Those with BRCA1/2 mutations and/or GII≥0 would be determined as HRD positive (HRD+). The physician can further evaluate whether PARP inhibitor (PARPi) treatment is suitable for these patients.

■How can HRD+ patients benefit from PARP inhibitor?

When the DNA of cancer cell breaks, these breaks will be repaired primarily via PARP protein and homologous
recombination repair (HRR), enabling cells to grow normally. If one of the HRR genes or BRCA1/2 is mutated, which
may result in HRD positive (HRD+), and then the cancer cell will only have the option of base excision repair.

For patients who have BRCA1/2 variants or are identified as HRD+, the latest therapy is to take PARP inhibitor. Known as an oral targeted drug, PARP inhibitor can interfere the DNA repair mechanism of cancer cell to cause the death thereof and to achieve therapeutic effect.

■ 50% of ovarian cancer patients are HRD+ and are suitable for PARP inhibitor treatment

SOFIVA HRD Status has increased the probability of finding a medication to 50%！

To find the maximum number of patients who can take PARP inhibitor therapy, HRD Status must be considered!

■ 28 HRR gene + Genomic Integrity Index (GII)
Detect HRD Status and HRR genes in a single assay

When a patient is HRD positive (HRD+), it means that his/her cancer cell cannot repair DNA and the accumulated DNA damage will cause genome instability.

SOFIVA HRD Status detects the DNA damage of cancer cell using the Low-pass WGS technology; transforms the result into images, and calculate GII using the deep-learning AI algorithms (CNN). If GII > 0, it means that the patient is HRD+.

Besides, 28 HRR genes – including BRCA1/2 – are also tested via NGS. This enables patients to know about their HRD and variant status, making the testing even more complete and attentive!

Suitable subjects

◆ Confirm if the patient is HRD positive.
◆ Ovarian cancer patients who desire to adopt PARP inhibitor therapy.
◆ Ovarian cancer patients who have taken BRCA1/2 genetic testing and still want to adopt PARP inhibitor treatment even though the testing result is normal.
◆ Ovarian cancer patients who use PARP inhibitor.
◆ Cancers that can be treated with PARP inhibitor.

Test specifications