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TEST:
FoundationOne® Liquid CDx

Company:
Roche
Type:
FDA Approved (PMA)
Related tests:
FoundationOne® Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test that uses targeted high throughput hybridization-based capture technology to detect and report substitutions, insertions and deletions (indels) in 311 genes, including rearrangements and copy number losses only in BRCA1 and BRCA2. FoundationOne® Liquid CDx utilizes circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of cancer patients collected in FoundationOne® Liquid CDx cfDNA blood collection tubes included in the FoundationOne® Liquid CDx Blood Sample Collection Kit. FoundationOne Liquid CDx is Intended to be used as a companion diagnostic for: EGFR Exon 19 deletions and EGFR Exon 21 L858R substitution in NSCLC with therapy TRESSA® (gefitinib), TAGRISSO® (osimertinib), TARCEVA® (erlotinib) and for BRCA1, BRCA2 alterations in mCRPC with therapy RUBRACA® (rucaparib).
Cancer:
Breast Cancer, Castration-Resistant Prostate Cancer, Colorectal Cancer, Non Small Cell Lung Cancer, Ovarian Cancer, Prostate Cancer
Gene:
ALK (Anaplastic lymphoma kinase), ARAF (A-Raf Proto-Oncogene), ATM (ATM serine/threonine kinase), BRAF (B-raf proto-oncogene), BRCA (Breast cancer early onset), BRCA1 (Breast cancer 1, early onset)
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Drug:
Akeega (abiraterone/niraparib), Alecensa (alectinib), Alunbrig (brigatinib), Braftovi (encorafenib), Erbitux (cetuximab), Exkivity (mobocertinib), Itovebi (inavolisib), Lynparza (olaparib), Mektovi (binimetinib), Piqray (alpelisib), Rozlytrek (entrectinib), Rubraca (rucaparib), Tabrecta (capmatinib), Tagrisso (osimertinib), Talzenna (talazoparib), erlotinib, gefitinib
Method:
Next-Generation Sequencing (NGS)
Confirmatory trial(s)