Molecular Diagnostics
News on lab-developed tests and emerging diagnostic technologies.
Foundation Medicine Test Approved by FDA as CDx for Itovebi in Breast Cancer Patients
The test is approved for patients with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer.
Burning Rock, Dizal Get Chinese Approval for Lung Cancer CDx
The test, approved by Chinese regulators in early 2022, is designed for the detection of multiple mutation statuses for nine genes.
Myriad Genetics Enters Collaborations to Study MRD, Announces Preliminary Q3 Revenue Estimates
The company is studying the use of its Precise MRD test in the breast cancer setting. It also said it estimates between $210 million and $212 million in Q3 revenue.
Velsera, Diagnóstica Longwood Partner for Precision Genomics Medicine in Spain, Portugal
The collaboration will bring together Velsera's clinical genomics analysis software with Diagnóstica Longwood's regional distribution knowledge and network.
Invivoscribe LeukoStrat CDx Gets CE Mark, EMA Approval
The PCR-based test is designed to help in the selection of acute myelogenous leukemia patients eligible for certain treatments.