{"entity":{"id":"mychoice-cdx","kind":"drug","name":"myChoice CDx","aka":[],"tldr":"A tumour test that measures DNA-repair scarring so that women with ovarian cancer beyond BRCA carriers can benefit from PARP inhibitors.","summary":"Approved 23 October 2019 (PMA P190014) with niraparib for homologous-recombination-deficient ovarian cancer after several lines of therapy, and in May 2020 as the companion diagnostic for olaparib plus bevacizumab first-line maintenance in HRD-positive ovarian cancer (PAOLA-1). Roughly half of high-grade serous ovarian cancers are HRD-positive by this definition, about twice the BRCA-mutated fraction. The scar is permanent, so a tumour can remain HRD-positive after it has developed resistance, one reason the test predicts benefit better in first-line than in later lines.","status":"approved","asOf":"2026-09-10","links":[{"label":"FDA PMA P190014","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190014"}],"tags":["test"],"related":[],"cancers":["ovarian","tnbc"],"sections":[],"technologies":["hrd-testing","companion-diagnostic"],"targets":["brca","parp"],"drugs":["niraparib","olaparib"],"companies":["myriad-genetics"],"institutions":[],"pathways":[],"terms":["hrd"],"trials":["paola-1","prima"],"people":[],"bottlenecks":[],"keyPapers":["paper-telli-hrd-score-platinum-tnbc-ccr-2016","paper-loibl-geparsixto-survival-hrd-ann-oncol-2018","paper-tutt-nat-med"],"journals":[],"dependsOn":[],"notes":["What a result means: HRD-positive (by genomic instability score or BRCA mutation) means adding a PARP inhibitor after chemotherapy is likely to delay relapse; HRD-negative means the benefit is much smaller.","Triple-negative breast cancer: the 42 genomic instability threshold was derived in TNBC platinum trials (Telli 2016) and HR deficiency by this definition was 70.5% in GeparSixto (Loibl 2018), but the score did not predict carboplatin benefit in TNT (Tutt 2018) and the assay has no breast indication."],"brand":"myChoice CDx","modality":"Tumour HRD genomic instability companion diagnostic test","mechanism":"Tumour BRCA1/2 sequencing combined with a genomic instability score (GIS) built from loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions; GIS ≥42 or a BRCA mutation defines HRD-positive.","approvals":[{"region":"US","year":2019,"indication":"Companion diagnostic for niraparib in HRD-positive advanced ovarian cancer"},{"region":"US","year":2020,"indication":"Companion diagnostic for olaparib plus bevacizumab first-line maintenance in HRD-positive ovarian cancer"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/mychoice-cdx/","neighbours":{"cancer":[{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"},{"id":"hrd-testing","kind":"technology","name":"HRD & BRCA testing","route":"/technologies/hrd-testing/"},{"id":"hrd-genomic-scar-scores","kind":"technology","name":"HRD genomic scar scores (GIS, LOH, HRDetect)","route":"/technologies/hrd-genomic-scar-scores/"}],"target":[{"id":"brca","kind":"target","name":"BRCA1 / BRCA2 (HRD)","route":"/targets/brca/"},{"id":"parp","kind":"target","name":"PARP","route":"/targets/parp/"}],"drug":[{"id":"niraparib","kind":"drug","name":"Niraparib","route":"/drugs/niraparib/"},{"id":"olaparib","kind":"drug","name":"Olaparib","route":"/drugs/olaparib/"}],"company":[{"id":"myriad-genetics","kind":"company","name":"Myriad Genetics","route":"/companies/myriad-genetics/"}],"term":[{"id":"hrd","kind":"term","name":"Homologous recombination deficiency (HRD)","route":"/terms/hrd/"}],"trial":[{"id":"paola-1","kind":"trial","name":"PAOLA-1 / ENGOT-ov25","route":"/trials/paola-1/"},{"id":"prima","kind":"trial","name":"PRIMA / ENGOT-OV26","route":"/trials/prima/"}],"paper":[{"id":"paper-tutt-nat-med","kind":"paper","name":"Carboplatin in BRCA1/2-mutated and triple-negative breast cancer BRCAness subgroups: the TNT Trial","route":"/key-papers/paper-tutt-nat-med/"},{"id":"paper-telli-hrd-score-platinum-tnbc-ccr-2016","kind":"paper","name":"Homologous recombination deficiency (HRD) score predicts response to platinum-containing neoadjuvant chemotherapy in patients with triple-negative breast cancer","route":"/key-papers/paper-telli-hrd-score-platinum-tnbc-ccr-2016/"},{"id":"paper-loibl-geparsixto-survival-hrd-ann-oncol-2018","kind":"paper","name":"Survival analysis of carboplatin added to an anthracycline/taxane-based neoadjuvant chemotherapy and HRD score as predictor of response-final results from GeparSixto","route":"/key-papers/paper-loibl-geparsixto-survival-hrd-ann-oncol-2018/"}],"biomarker":[{"id":"hrd-positive","kind":"biomarker","name":"HRD-positive (genomic instability score)","route":"/biomarkers/hrd-positive/"},{"id":"brca-somatic","kind":"biomarker","name":"Tumour (somatic or germline) BRCA1/2 mutation and HRR gene alterations","route":"/biomarkers/brca-somatic/"}]}}