Natera Announces Collaboration with Diakonos Oncology for Signatera™ in Refractory Melanoma

Key Terms

cell-free dna medical

Fragments of DNA that float freely in the bloodstream after being released by dying or damaged cells, like puzzle pieces carried downstream that hint at what’s happening upstream. Investors care because measuring these fragments enables non‑invasive tests — for example to detect cancer, monitor treatment response, check pregnancy health, or spot organ rejection — so advances, approvals, or reimbursement changes can quickly affect companies that develop the tests and related technologies.

dendritic cell therapy medical

A form of immunotherapy that uses a patient’s own immune “sentinel” cells, called dendritic cells, which are loaded or taught to recognize disease signals and then returned to the body to activate an immune attack. Think of dendritic cells as teachers training the immune system’s soldiers to find and fight a hidden enemy. For investors, success or failure affects clinical milestones, regulatory approval, development costs and potential market size, so progress can sharply change a company’s value.

fast track designation regulatory

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

circulating tumor dna medical

Fragments of DNA shed by cancer cells into the bloodstream that act like tiny fingerprints of a tumor; they can be detected with a blood test rather than a biopsy. Investors care because circulating tumor DNA (ctDNA) enables faster, lower-cost ways to detect disease, track treatment response, identify emerging resistance and enroll patients in trials—factors that can materially affect the commercial prospects of diagnostics and therapeutics.

ctdna medical

Circulating tumor DNA (ctDNA) is tiny fragments of genetic material shed by cancer cells into the bloodstream, like breadcrumbs that can reveal a tumor’s presence and genetic makeup without needing a biopsy. For investors, ctDNA matters because tests and technologies that detect and analyze these fragments can speed diagnosis, track treatment response, and signal relapse, creating commercial opportunities in diagnostics, personalized therapies, and monitoring services.

refractory melanoma medical

A form of melanoma — a skin cancer — that does not respond or stops responding to one or more standard treatments. For investors, refractory melanoma matters because it creates urgent unmet medical need, which can drive demand for new drugs, affect the size and speed of clinical trials, and influence regulatory attention and potential market value if an experimental therapy shows benefit; think of it as a problem existing treatments can’t fix, creating opportunity for effective alternatives.

immunotherapy medical

Treatment that uses or enhances the body’s immune system to detect and fight disease, most often cancers or chronic infections; think of it as training or arming the body’s own soldiers to find and destroy targets. It matters to investors because successful immunotherapies can lead to high-value drug approvals, recurring revenue from long-term treatments, and changes in competitive dynamics, while failures or safety issues in clinical trials can materially affect company valuations.

mrd medical

MRD stands for minimal residual disease, the tiny number of cancer cells that can remain in the body after treatment and that may not show up on routine scans. Detecting MRD is like finding a few seeds left in a garden after clearing: it helps doctors predict the chance of relapse and measure how effective a therapy is, which investors watch because MRD results can influence clinical trial success, regulatory decisions, and a drug’s market potential.

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Signatera™ to evaluate molecular response to investigational dendritic cell therapy as part of Diakonos’ Phase I/II trial

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced a new collaboration with Diakonos Oncology Corp., a clinical-stage biotechnology company developing immunotherapies to treat challenging and aggressive cancers. As part of the collaboration, Signatera will be used to longitudinally assess molecular response in patients with refractory melanoma enrolled in Diakonos’ DOC-RM Phase I/II investigational immunotherapy trial.

The DOC-RM trial, which began enrollment in May, is evaluating DOC1021 (dubodencel), a first-in-class, personalized dendritic cell investigational therapy that recently received Fast Track designation by the U.S. Food and Drug Administration (FDA) in unresectable or metastatic cutaneous melanoma. With Signatera, Natera will conduct analyses of circulating tumor DNA (ctDNA) at multiple timepoints during and following treatment.

Refractory melanoma is an area of significant unmet need. Although immunotherapy has transformed the treatment landscape for advanced melanoma, many patients either do not respond or eventually develop resistance, underscoring the need for novel therapeutic approaches. Because radiographic response assessment can be challenging in immunotherapy-treated patients, serial ctDNA monitoring may provide earlier insight into molecular response and disease dynamics during treatment.¹

"With an FDA Fast Track designation in hand, DOC1021’s path forward in refractory melanoma will benefit from early, high-quality evidence of activity,” said Jay Hartenbach, president and COO of Diakonos Oncology. “Natera’s Signatera test is the most trusted tumor-informed MRD platform in oncology, making them a natural partner to help evaluate molecular response in a population where imaging often lags the biology.”

“Signatera is uniquely positioned to help biopharma partners evaluate molecular response throughout the course of therapy, and we are thrilled to partner with Diakonos on this exciting program,” said Eric Matthews, general manager, BioPharma, Natera. “By assessing MRD status across multiple timepoints, this collaboration has the potential to provide deep insight into treatment response dynamics and support future development efforts for patients with difficult-to-treat cancers.”

Resources

1. Ribas A, et al. Search for effective treatments in patients with advanced refractory melanoma. Journal for ImmunoTherapy of Cancer. 2021;9:e002820. doi:10.1136/jitc-2021-002820.

About Natera

Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 400 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our or our partners’ efforts to develop and commercialize new product offerings, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260529102657/en/

Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

Source: Natera, Inc.