Business in Brief
The latest business news in the world of diagnostic medicine
Luke Turner | | Quick Read
Making a Mark
A PCR-based test for determining microsatellite instability (MSI) status in solid tumors has received the CE mark as a new in vitro diagnostic medical device. OncoMate™ MSI provides a DNA-based MSI reading complementary to a standard MMR immunohistochemistry panel, which can be used to predict response to immuno-oncology therapies (1).
Spying a Treatment
Quantum Leap Healthcare Collaborative has selected Byondis B.V.’s investigational antibody-drug conjugate, SYD985, in its ongoing I-SPY 2 TRIAL™ for neoadjuvant breast cancer treatment. The trial aims to rapidly screen and identify promising treatments in specific subgroups of women with newly diagnosed, high-risk, and locally advanced cancer (2).
To the Bone
A new type of predictive test for osteoporosis provides early insights into the bone mineral balance of the human body using a urine or blood sample. In a study of 100 women, the OsteoTest predicted fractures caused by bone atrophy more accurately and less invasively than current X-ray-based methods (3).
Beckman Coulter’s Access SARS-CoV-2 IgG assay has received Emergency Use Authorization from the US Food and Drug Administration. The assay, which is in over 400 hospitals, clinics, and diagnostic laboratories in the US, will now be distributed worldwide – and the company says it can produce over 30 million tests every month (4).
An analysis of 929 genomes from patients who responded poorly to COVID-19 has revealed 68 genes associated with severe disease. Researchers hope the genes – nine of which are already targets of drugs that have reached at least Phase I clinical trials – will inform the development of biomarker-driven tests and new therapeutic strategies (5).