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DELFI Diagnostics Announces Availability of New Fragmentome-Based Cancer Treatment Monitoring Assay

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DELFI Diagnostics, Inc. has announced the availability of the DELFI-Tumor Fraction (DELFI-TF) assay, a highly sensitive and inexpensive means of noninvasive measurement of tumor burden and assessing treatment response and resistance in patients with advanced cancer. The company has also entered a new research collaboration with Immunocore Holdings plc (Nasdaq: IMCR) to explore the use of the DELFI-TF cancer monitoring assay as an early predictor of benefit from treatment with ImmTAC-based therapies. The assay delivers a genome-wide measure of the proportion of cfDNA derived from a tumor and has numerous advantages, including low cost and minimal plasma requirement. The assay is also being evaluated by additional parties across the pharmaceutical industry for its potential application in advancing other healthcare discoveries.
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The collaboration between DELFI Diagnostics and Immunocore Holdings represents a significant advancement in the field of oncology, particularly in the application of liquid biopsies for cancer monitoring. The DELFI-TF assay leverages the concept of fragmentome-based analysis, which involves studying the entire set of cell-free DNA (cfDNA) fragments in the blood to detect tumor-derived DNA. This approach is innovative as it offers a noninvasive alternative to traditional tissue biopsies, potentially facilitating more frequent and less burdensome monitoring of tumor burden.

From a medical research perspective, the assay's ability to correlate with the mutant allele fraction (MAF) is noteworthy. MAF is a critical biomarker in assessing how patients respond to cancer treatments, especially immunotherapies. The potential of the DELFI-TF assay to predict treatment benefits early could lead to more personalized and effective treatment regimens. This could have a profound impact on patient outcomes and may also influence the design of clinical trials by providing a tool for early assessment of therapeutic efficacy.

From a market perspective, the collaboration between DELFI and Immunocore could have significant implications for the liquid biopsy market, which is rapidly growing due to its promise of noninvasive cancer detection and monitoring. The cost-effectiveness and practicality of the DELFI-TF assay could position it favorably in a competitive landscape. As healthcare systems and insurers increasingly focus on cost containment, the adoption of more affordable and efficient diagnostic tools like the DELFI-TF assay is likely to increase.

Furthermore, the interest from additional pharmaceutical parties suggests that the assay has a broad appeal and potential for integration into various therapeutic areas. This could lead to expanded market opportunities for DELFI and its collaborators. Announcements of further research collaborations could serve as catalysts for investor interest, potentially impacting the stock prices of the companies involved.

Financially, the strategic alliance between DELFI and Immunocore could enhance both companies' valuation if the DELFI-TF assay demonstrates clinical utility in predicting treatment efficacy. The assay's low cost and minimal plasma requirements could translate into a competitive advantage and drive adoption in clinical settings, potentially leading to revenue growth for DELFI. For Immunocore, the ability to pair its ImmTAC-based therapies with a predictive monitoring tool could improve treatment outcomes and strengthen its market position in TCR immunotherapies.

Investors will likely monitor upcoming data from the research collaboration closely, as positive results could lead to increased confidence in both companies' pipelines and technologies. However, it is essential to remain cautious, as the success of the assay in clinical practice is contingent upon rigorous validation studies and potential regulatory approvals.

 DELFI and Immunocore enter research collaboration with assay for cancer monitoring in multiple solid tumor types

PALO ALTO, Calif. and BALTIMORE, Feb. 1, 2024 /PRNewswire/ -- DELFI Diagnostics, Inc., a developer of accessible blood-based tests that deliver a new way to enhance cancer detection, today announced availability of the company's fragmentome-based research use only (RUO) cancer monitoring assay. The DELFI-Tumor Fraction (DELFI-TF) assay is a highly sensitive, inexpensive means of noninvasive measurement of tumor burden and assessing treatment response and resistance in patients with advanced cancer.

Additionally, DELFI announced a new research collaboration with Immunocore Holdings plc (Nasdaq: IMCR) – a commercial-stage biotechnology company pioneering the development of a novel class of bispecific T cell receptor (TCR) immunotherapies against cancer (ImmTAC molecules) – focused on exploring the use of the DELFI-TF cancer monitoring assay as an early predictor of benefit from treatment with ImmTAC-based therapies.

"The DELFI-TF assay delivers a genome-wide measure of the proportion of cfDNA derived from a tumor and it is highly correlated with the mutant allele fraction (MAF) that is often used to evaluate treatment response and resistance to immunotherapies in advanced cancer patients. Our fragmentome-based assay has numerous advantages as it requires very little plasma, has a low cost of processing, and is not confounded by clonal hematopoiesis or driver mutation switches," said Nicholas C. Dracopoli, Ph.D., co-founder and Chief Scientific Officer of DELFI. "We are excited that Immunocore will be further exploring the clinical and research potential of the DELFI liquid biopsy platform as a new approach to monitoring treatment response."

The DELFI-TF RUO assay is also being evaluated by additional parties across the pharmaceutical industry for its potential application in advancing other healthcare discoveries, and DELFI anticipates announcing more research collaborations in the near term.

About DELFI Diagnostics
DELFI Diagnostics is developing next-generation, blood-based tests that are accurate, accessible and deliver a new way to help detect cancer. Employing advanced machine-learning methods to whole-genome sequencing data, the DELFI platform is built to address the highest-burden health challenges. We prioritize solutions that have the potential to save lives on a global scale, including for historically underserved populations. DELFI's platform relies on fragmentomics – the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments. FirstLook Lung, for individuals eligible for lung cancer screening, is our first laboratory-developed screening test and can be part of routine blood work. FirstLook Lung uses millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early stage disease, with a negative predictive value of 99.7 percent. This test has not been cleared or approved by the FDA. For more information, visit www.delfidiagnostics.com.

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SOURCE DELFI Diagnostics

FAQ

What is the DELFI-TF assay?

The DELFI-TF assay is a highly sensitive and inexpensive means of noninvasive measurement of tumor burden and assessing treatment response and resistance in patients with advanced cancer.

What is the research collaboration between DELFI and Immunocore about?

The collaboration aims to explore the use of the DELFI-TF cancer monitoring assay as an early predictor of benefit from treatment with ImmTAC-based therapies.

What are the advantages of the DELFI-TF assay?

The assay delivers a genome-wide measure of the proportion of cfDNA derived from a tumor and has numerous advantages, including low cost and minimal plasma requirement.

Who is involved in evaluating the DELFI-TF assay?

The assay is being evaluated by additional parties across the pharmaceutical industry for its potential application in advancing other healthcare discoveries.

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