Australia - engelsk - Department of Health (Therapeutic Goods Administration)

genome investigation pty ltd - ct910 - interpretive software ivds - the agendia-secured data analysis pipeline tool (adapt) takes gene expression profiling data (.fastq file) from the mammaprint breast cancer recurrence risk and blueprint molecular subtyping kit (see artg 356739) to generate both a breast cancer distant recurrence risk and a molecular subtype (luminal, basal or her2) of the formalin-fixed, paraffin-embedded (ffpe) breast cancer tissue.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

genome investigation pty ltd - ct929 - acquired genetic alteration ivds - the mammaprint breast cancer recurrence risk and blueprint molecular subtyping ngs kit is an in vitro diagnostic which generates data (.fastq file) from gene expression profiling of breast cancer tissue performed by next generation sequencing. this data is used to generate both a breast cancer distant recurrence risk and a molecular subtype (luminal, basal or her2) via a second step using the agendia-secured data analysis pipeline tool (adapt) (see artg 356740). the assay measures the gene expression profile on a next generation sequencer using rna extracted from formalin-fixed, paraffin-embedded (ffpe) breast cancer tissue.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

philips electronics australia ltd - ct943 - instrument/analyser ivds - the philips intellisite pathology solution (pips) is an automated digital slide creation, viewing, and management system. the pips is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (ffpe) tissue. the pips is not intended for use with frozen section, cytology, or non-ffpe hematopathology specimens. the pips comprises the image management system (ims), the ultra fast scanner (ufs) and/or the pathology scanner sg20 / sg60 / sg300. the pips is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. it is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using pips.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

metagene pty ltd - ct943 - instrument/analyser ivds - the oncore pro automated microscope slide staining system is a compact bench-top instrument that is capable of performing immunohistochemistry (ihc) and in-situ hybridization (ish) procedures on formalin-fixed paraffin-embedded (ffpe) tissue mounted on a microscope slide

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

leica biosystems melbourne pty ltd - ct944 - software ivds - a viewing software application intended to be used with an ivd instrument/analyser (eg., microscope slide digital imaging scanner, immunoassay analyser), to enable the pathologist with the qualitative review and interpretation of digital images of glass slides prepared from formalin-fixed embedded tissue (ffpe)

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct1056 - immunohistology cell marker ivds - immunohistochemical staining of tissues for pd-l1 protein as an aid in identifying patients eligible for treatment with nominated therapies in selected indications intended for the qualitative detection of the programmed death ligand 1 (pd-l1) protein in formalin-fixed, paraffin-embedded (ffpe) non-small cell lung cancer (nsclc) tissue

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct1056 - immunohistology cell marker ivds - immunohistochemical staining of tissues for alk protein as an aid in identifying patients eligible for treatment with nominated therapies in selected indications intended for qualitative detection of the anaplastic lymphoma kinase (alk) protein in formalin-fixed, paraffin-embedded non-small cell lung carcinoma (nsclc) tissue.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct929 - acquired genetic alteration ivds - for determination of her2 gene status by enumeration of the ratio of the her2 gene to chromosome 17 by light microscopy as an aid in identifying patients eligible for treatment with nominated therapies in selected indications. intended to determine her2 gene status by enumeration of the ratio of the her2 gene to chromosome 17 using two-color chromogenic in situ hybridization (ish) in formalin-fixed, paraffin-embedded human breast and gastric carcinoma tissue specimens

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

bio-strategy pty ltd - ct929 - acquired genetic alteration ivds - the prosigna breast cancer prognostic gene signature assay is an in vitro diagnostic which uses the gene expression profile of cells found in breast cancer tissue to assess a patient's risk of distant recurrence. the gene expression data are weighted together with clinical variables to generate both a subtype (luminal a, luminal b, her2-enriched, or basal like) and a score indicative of the probability of distance recurrence of disease. the assay measures the gene expression profile using rna extracted from formalin-fixed, paraffin-embedded (ffpe) breast tumor tissue. veracyte confirm that veracyte inc. has the design controls for the device.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct929 - acquired genetic alteration ivds - the primary use of the cobas? 4800 braf v600 mutation test is the detection of the braf v600 mutations in dna extracted from formalin-fixed, paraffin-embedded human melanoma and papillary thyroid carcinoma (ptc) tissue. in melanoma, it is intended to be used as an aid in selecting patients whose tumors carry braf v600 mutations for treatment either with zelboraf? (vemurafenib) alone, or with cotellic? (cobimetinib) in combination with zelboraf? (vemurafenib). ivds that are intended to be used in genetic testing to provide information about acquired genetic alterations, which may include chromosomal alterations, mutations and/or alterations in gene expression, and which may be used to characterise haematological or solid tumour malignancies and/or provide prognostic information.