SWITZERLAND — Roche has expanded its collaboration with Janssen Biotech to develop companion diagnostics for targeted therapies for an undisclosed amount.

New agreement expands activities to include a wide range of companion diagnostics, including tissue and blood-based biomarkers, sequencing, and digital pathology.

The collaboration is based on a commitment to individualized healthcare, expanding the availability of diagnostics to enable patient-directed treatment options.

Companion diagnostics have the ability to identify patients who are most likely to benefit from a particular therapy as well as those who have an increased risk for serious side effects from a certain treatment.

Additionally, these tests are designed to monitor response to specific drugs to adjust treatment to ensure improved safety or effectiveness, according to the FDA.

The market for companion diagnostics has expanded significantly over the last decade and is expected to expand further in the coming years.

According to Fortune Business Insights, the Companion Diagnostics Market size was valued at US$6.80 billion in 2021 and is expected to reach US$15.91 billion by 2029, displaying a CAGR of 11.0% during the forecast period.

The increasing availability of new and innovative technologies, such as next-generation sequencing (NGS), microarray analysis, and PCR-based assays, is one of the key drivers of growth in the companion diagnostics market.

These technologies enable the quick and low-cost identification of specific genetic mutations and markers that can be used to guide treatment decisions and improve patient outcomes.

“Through collaboration, we aim to help advance personalized healthcare by developing tests that make more targeted therapies available to the patients who need them,” Jill German, head of the pathology lab at Roche Diagnostic, said in a statement.

Examples of projects that may develop as a result of this collaboration include exploring data and tissue image analysis and the development of a new IHC assay to support patient identification and enrollment for personalized treatment, Roche added.

Elizabeth A. Mansfield, Ph.D., noted in an article published in Clinical Cancer Research that scientists recognized the path to companion diagnostics in 1998 with the approval of trastuzumab.

The scientists discovered that only women with breast tumors overexpressing the human epidermal growth factor receptor 2 (HER2) receptor benefited from the drug, which was designed to target the protein.

To detect the amount of HER2 present and determine the necessary amount for response to the therapy, the scientists developed a new in vitro diagnostic device called HercepTest.

Mansfield wrote that this marked the birth of the companion diagnostic model and showed how the FDA’s approach to companion diagnostics must evolve as new tests are developed and risks and benefits are recalculated.

Recently, Roche also announced a collaboration agreement with Jana Care, an early-stage at-home in vitro diagnostics company, for its digitally connected, blood testing platform to enable patients to self-administer critical blood tests at home and clinicians to review the test results remotely.

Meanwhile, the FDA approved Guardant360 CDx as a companion diagnostic (CDx) in conjunction with the approval of ORSERDU for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated, advanced or metastatic breast cancer that has progressed after at least one line of endocrine therapy.

The approval as a companion diagnostic for ORSERDU is Guardant Health’s fifth FDA approval for the Guardant360 CDx test and its first in breast cancer.

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