1726 – Testing of tumour tissue to determine a positive homologous recombination deficiency status in women newly diagnosed with advanced (FIGO stage III-IV) high grade epithelial ovarian, fallopian tube or primary peritoneal cancer, for access to PBS niraparib

Page last updated: 14 July 2023

Application Detail

Description of Medical Service

The medical service is for the testing of tumour tissue to determine HRD status. The HRD test involves the next generation sequencing (NGS) of DNA from a biopsy or preserved specimens (archived FFPE block) of tumour tissue. An assay detects how your body repairs double strand breaks in DNA, which is constantly being damaged and repaired. When DNA is repaired, the process is called homologous recombination. HRD positive means your body is unable to effectively repair these double strand breaks in the DNA. HRD can include a number of genes, including BRCA1 and BRCA1 genes.

Description of Medical Condition

Ovarian cancer is a diverse disease comprising different subtypes. The majority of ovarian cancers are of epithelial origin, with most classified as high-grade tumours. Early symptoms are often nonspecific, such as pelvic or abdominal discomfort, bloating, difficulty eating or feeling full and urinary urgency or frequency. Most patients are therefore diagnosed at an advanced stage (Stage 3 and 4) when prominent symptoms such as ascites (fluid build-up in spaces within the abdomen) and abdominal masses are evident.

Reason for Application

New MBS item

Medical Service Type

Investigative – PBAC codependent application

Previous Application Number/s

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 1659 KB)
Application Form (Word 475 KB)

Consultation Survey

Consultation Survey (PDF 659 KB)
Consultation Survey (Word 27 KB)

PASC Consultation
Expedited – Bypassing PASC

MSAC Consultation
MSAC consultation input closed Friday, 10 February 2023.

For further information please refer to PASC, ESC, MSAC Key Dates
For further information on the consultation process please refer to MSAC Consultation Process

PICO Confirmation


Assessment Report


Public Summary Document

Public Summary Document (PDF 1112 KB)
Public Summary Document (Word 639 KB)

Meetings for this Application


Bypassing PASC


9-10 February 2023


30-31 March 2023