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The ratio of these biomarkers (pTau181/Abeta42) is consistent with a negative beta‑amyloid PET scan if the result is less than or equal to the cutoff (negative), and with a positive beta‑amyloid PET scan if the result is above the ratio cutoff (positive).

Abeta42 and pTau181 assays are intended to be used in addition to other clinical diagnostic evaluations to determine whether a person has Alzheimer’s. A positive pTau181/Abeta42 ratio result in CSF does not establish a diagnosis of Alzheimer’s disease.

FDA approves CDx to Krazati in NSCLC

The Food and Drug Administration approved Qiagen’s Therascreen KRAS RGQ PCR kit as a companion diagnostic test to Mirati Therapeutics’ drug Krazati (adagrasib) for non-small cell lung cancer.

Qiagen and Mirati announced their cooperation in May 2021. The tissue-based KRAS companion diagnostic assay, which Qiagen developed to identify patients with NSCLC who have a KRAS G12C mutation, is instrumental in determining who may benefit from treatment with Krazati. The drug is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.

De novo classification granted to HLA typing test for use as CDx

The Food and Drug Administration granted de novo classification to Thermo Fisher’s SeCore CDx HLA Sequencing System for use as a companion diagnostic with Kimm­trak (tebentafusp-tebn), Immunocore’s T-cell receptor therapy for HLA-A*02:01-positive adults with metastatic or unresectable uveal melanoma. The marketing authorization makes the SeCore CDx HLA Sequencing System the only commercially available HLA typing companion diagnostic.

Kimmtrak, the only FDA-approved T-cell receptor therapy for metastatic or unresectable uveal melanoma, is indicated for adults who are HLA-A*02:01 positive. The SeCore CDx HLA Sequencing System was used to identify HLA-A*02:01-positive patients for enrollment in Kimmtrak clinical trials.