The FDA has issued premarket approval for Thermo Fisher Scientific's ( NYSE: TMO ) Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients with HER2 activating mutations in their non-small cell lung cancer who might be eligible for antibody-drug conjugate Enhertu.
The approval follows the FDA clearance of the HER2-directed therapy developed by AstraZeneca ( AZN ) and Daiichi Sankyo ( OTCPK:DSKYF ) ( OTCPK:DSNKY ) on Thursday for adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors express HER2 mutations.
According to the decision, the patients detected by an FDA-approved test and those who received prior systemic therapy would be candidates for Enhertu.
Oncomine Dx, designed to detect 23 genes linked to NSCLC, first received FDA clearance in 2017. In the U.S., it's approved to guide seven targeted therapies for NSCLC and one for cholangiocarcinoma.
Read: Thermo Fisher's specialty diagnostics business recorded $1.1B in revenue for 2Q 2022 with an ~11% YoY decline.
For further details see:
Thermo wins FDA nod for Oncomine Dx to find lung cancers with HER2 mutations