Date: 2017-06-29
Type of information: Granting of a Market Authorisation in the US
Product name: Extended RAS Pane
Compound:
Therapeutic area: Cancer - Oncology - Diagnostic
Action mechanism: companion diagnostic
Company: Illumina (USA - CA)
Disease: colorectal cancer
Latest news:
- • On June 29, 2017, Illumina announced its Extended RAS Panel , an FDA -approved next-generation sequencing (NGS) kit that meets the newly published guidelines for evaluation of colorectal cancer from the American Society for Clinical Pathology (ASCP), the College of American Pathologists (CAP), the Association for Molecular Pathology (AMP), and the American Society of Clinical Oncology ( ASCO ).
- This kit is intended to be used on the Illumina MiSeqDx® System and enables U.S. laboratories to help clinicians identify which patients are eligible for treatment of metastatic colorectal cancer with Vectibix® (panitumumab).
- The Extended RAS Panel offers RAS testing to determine eligibility for EGFR inhibitors in metastatic colorectal cancer. It allows the simultaneous detection of 56 RAS mutations contraindicated for anti-EGFR therapy The Extended RAS Panel will begin shipping in Q3 2017. For more information,
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2017-06-29
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
