Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that Guardant360® CDx has received CE-marking under Europe’s in Vitro Diagnostic Medical Devices Regulation as a companion diagnostic (CDx) to identify patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer who may benefit from treatment with ETCAMAH™ (camizestrant), AstraZeneca’s next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist. Approval in Europe reinforces Guardant Health's commitment to enabling practice-changing ongoing monitoring across the world's largest healthcare markets.

CellCarta, a leading global CRO laboratory to the biopharmaceutical industry, today announced a strategic partnership with Waters Corporation, a global leader in life sciences and diagnostics, creating a framework to jointly pursue companion diagnostic (CDx) and next-generation flow cytometry opportunities with pharmaceutical and biotechnology companies.

SOPHiA GENETICS (NASDAQ: SOPH) and Myriad Genetics, Inc., (NASDAQ: MYGN) today announce a collaboration to advance new prostate cancer-specific genomic instability score (PrGIS) technology to support precision oncology approaches with AstraZeneca (LSE/STO/NYSE: AZN). PrGIS is a novel biomarker signature designed to assess chromosomal instability associated with homologous recombination deficiency (HRD) in prostate cancer patients. The collaboration aims to advance PrGIS in clinical trials and expand access to precision oncology medicines through potential companion diagnostic solutions.

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that its Signatera test has received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) as a companion diagnostic (CDx) in muscle-invasive bladder cancer (MIBC).

Amoy Diagnostics Co., Ltd. (“AmoyDx,” SZSE: 300685) today announced that its AmoyDx® HRD Complete Panel has received certification under the European Union In Vitro Diagnostic Medical Devices Regulation (IVDR) by TÜV SÜD Product Service GmbH for use as a companion diagnostic to aid in identifying patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations ( germline and /or somatic) who may be eligible for treatment with olaparib monotherapy who have progressed following prior therapy that included a novel hormonal agent.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360® CDx as a companion diagnostic (CDx) to identify patients with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer harboring tumors with ESR1 mutations before radiographic progression who may benefit from treatment with ETCAMAH™ (camizestrant), AstraZeneca’s next-generation oral selective estrogen receptor degrader (SERD). Guardant360 CDx is the first FDA-approved liquid biopsy CDx for longitudinal testing in breast cancer, and this approval represents a major shift from therapy selection and switching post-radiographic progression to adaptive cancer management and early interception using pre-radiographic progression circulating tumor DNA (ctDNA) testing.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received FDA approval for expanded use of its PATHWAY® HER2 (4B5) and VENTANA® HER2 Dual ISH DNA Probe Cocktail tests. These companion diagnostics are now approved to assess HER2-positive status in metastatic gastroesophageal adenocarcinoma (GEA) patients, including those with gastric, gastroesophageal junction, and esophageal adenocarcinoma. The approval enables clinicians to identify HER2-positive GEA patients who may be eligible for HER2-targeted treatment with Jazz Pharmaceuticals' ZIIHERA® (zanidatamab-hrii). Two ZIIHERA-containing regimens are now FDA approved for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive GEA.

Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced that the U.S. Food and Drug Administration (FDA) has approved Labcorp's PGDx elio® tissue complete CDx as a companion diagnostic to help identify patients with advanced melanoma with certain BRAF variants who may benefit from treatment with FDA-approved targeted therapies.

Agilent Technologies Inc. (NYSE: A) today announced that it has received U.S. Food and Drug Administration (FDA) approval for the PD‑L1 IHC 28‑8 pharmDx assay as a companion diagnostic to identify patients with esophageal squamous cell carcinoma (ESCC), gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma who may be eligible for treatment with OPDIVO® (nivolumab) or OPDIVO QVANTIG® (nivolumab and hyaluronidase‑nvhy), Bristol Myers Squibb’s PD‑1‑targeted immunotherapeutic agents. PD-L1 IHC 28-8 pharmDx is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution.

Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the VENTANAⓇ PTEN (SP218) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test to receive U.S. Food and Drug Administration (FDA) approval for determining PTEN protein loss, also known as PTEN deficiency, in tumours of patients with prostate adenocarcinoma. These patients may now be eligible for treatment with AstraZeneca’s targeted therapy TRUQAPⓇ (capivasertib).