Karius®, Inc., a leader in genomic diagnostics for infectious diseases, announced today that the Karius Test® has been granted designation as a Breakthrough Device from The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA), for use in the diagnosis and management of immunocompromised patients with suspected lung infections including lower respiratory infection and pneumonia.

Thermo Fisher Scientific and AstraZeneca are collaborating on the development of a new solid tissue and blood-based companion diagnostic (CDx) test for Tagrisso (osimertinib).

Guangzhou MyGene Medical Technology Co., Ltd. announced the completion of several hundred million yuan in Series C financing. This round of financing was led by Efung Capital, the funds will be used for R&D and product registration for the IVD products.

Foundation Medicine said Wednesday its FoundationOne Liquid CDx test has been approved by the US Food and Drug Administration as a companion diagnostic for epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI).

Precision Medicine Asia and the National Cancer Center Hospital East in Japan are building a lung cancer clinicopathological genomic database and screening infrastructure that spans seven countries in the Asia-Pacific region, the groups said Wednesday.

Cofactor Genomics on Wednesday announced the commencement of a study of its OncoPrism assay in non-small cell lung cancer (NSCLC).

Roche said on Wednesday that its Ventana PD-L1 test has received a CE label expansion for its Ventana PD-L1 SP263 test to determine non-small cell lung cancer patients' eligibility for Roche's immune checkpoint inhibitor Tecentriq (atezolizumab).

Guardant Health and Thermo Fisher Scientific said on Friday that the US Food and Drug Administration has granted premarket approvals for their respective next-generation sequencing assays as companion diagnostics to Enhertu (trastuzumab deruxtecan)

The Japan Ministry of Health, Labour and Welfare (MHLW), Japan's regulatory agency, has granted approval to the Thermo Fisher Scientific's Oncomine Dx Target Test to be used as a companion diagnostic to identify patients with RET-fusion positive non-small cell lung cancer (NSCLC).

Oncocyte said it has completed Clinical Laboratory Improvements Amendments (CLIA) validation for its DetermaIO. The Irvine, CA-based company said the diagnostic, which was previously known as the Insight Genetics IM Score Test, is used in l