Guardant Health Japan Corp. (HQ: Minato-ku, Tokyo/ Representative Director: Mika Takaki), a leading precision oncology company, today announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has approved Guardant360® CDx as a companion diagnostic to identify EGFR exon 20 insertion mutations in patients with inoperable or recurrent non-small cell lung cancer (NSCLC) for consideration of treatment with amivantamab-vmjw combined with chemotherapy.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the expansion of its Master Collaboration Agreement with AstraZeneca to develop and commercialize companion diagnostics (CDx) for AstraZeneca’s future therapies being developed to address chronic diseases.

Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced Food and Drug Administration (FDA) approval of its in vitro diagnostic (IVD) TruSight™ Oncology (TSO) Comprehensive test and its first two companion diagnostic (CDx) indications.

Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) announces today that it has expanded its strategic Alliance Agreement with QIAGEN N.V. (HQ: Venlo, The Netherlands; CEO: Thierry Bernard) to deepen their collaboration in genetic testing, including research and development, production, clinical development, and sales-marketing.

Thermo Fisher Scientific Inc., the world leader in serving science, today announced that its SeCore™ CDx HLA A Sequencing System has been granted 510(k) clearance by the United States Food and Drug Administration (FDA) for use as a companion diagnostic with TECELRA® (afamitresgene autoleucel), Adaptimmune’s newly approved T-cell receptor (TCR) therapy for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. Synovial sarcoma is a rare, soft tissue cancer that most commonly impacts young adults.1,2

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, today announced a global collaboration agreement to develop, manufacture and commercialize flow cytometry-based companion diagnostics (CDx) intended to help select the best treatment for patients with cancer and other diseases.

Roche subsidiary Foundation Medicine said Monday that the US Food and Drug Administration has approved its liquid biopsy test, FoundationOne Liquid CDx, as a companion diagnostic to identify advanced BRCA-mutated prostate cancer patients who are eligible for treatment with Janssen's Akeega (niraparib and abiraterone acetate).

AmoyDx, a China-based innovative molecular diagnostics company, and Servier, an independent international pharmaceutical group, announced today they have entered into a strategic partnership to develop a companion diagnostic test (CDx) in China that detects Isocitrate Dehydrogenase (IDH) 1&2 gene mutations. This test will be developed for vorasidenib, Servier’s investigational dual inhibitor of mutant IDH1 and mutant IDH2 enzymes, for Chinese patients with diffuse IDH-mutant glioma (LGG).

Roche announced this week that its Ventana PD-L1 (SP263) assay received a CE-IVDR label expansion for use as a companion diagnostic with Regeneron's Libtayo (cemiplimab) in combination with platinum-based doublet chemotherapy in lung cancer patients.

Myriad Genetics announced Tuesday that GlaxoSmithKline is sponsoring a program to boost access to homologous recombination deficiency (HRD) diagnostic testing for high-grade serous ovarian cancer (HGSOC) patients in nine countries via Myriad's MyChoice HRD Plus and MyChoice CDx Plus tests.