Delfi Diagnostics has put forward a new cancer monitoring test that searches the blood for broken pieces of tumor DNA, and it is kicking off the test’s launch with a collaboration with Immunocore to explore its use in multiple malignancies.
The fragmentome-based liquid biopsy test is currently limited to research use only. Delfi describes it as a highly sensitive means of measuring tumor burden and gauging a cancer’s response or resistance to treatment.
“The DELFI-TF assay delivers a genome-wide measure of the proportion of [cell-free DNA] derived from a tumor and it is highly correlated with the mutant allele fraction that is often used to evaluate treatment response and resistance to immunotherapies in advanced cancer patients,” Nicholas Dracopoli, Delfi’s co-founder and chief scientific officer, said in a statement.
Immunocore, meanwhile, will help explore the clinical and research potential of the assay, Dracopoli said. The U.K.-based developer of bispecific T-cell receptor immunotherapies will also examine the test’s use as an early predictor of patient benefit from its treatments.
Immunocore claimed the first FDA approval for a T-cell receptor-powered therapeutic in early 2022 with Kimmtrak (tebentafusp-tabn), which also marked the first therapy greenlit for unresectable or metastatic uveal melanoma, an aggressive cancer of the eye. With a weekly dose originally priced at $18,760 per vial, Kimmtrak was one of the most expensive U.S. drugs in 2023, totaling about $975,000 per year.
Now, Immunocore aims to increase commercial access to Kimmtrak and is conducting trials of the drug in advanced cutaneous melanoma and adjuvant uveal melanoma. Other investigational T-cell treatments are being trialed in lung, ovarian, colorectal and gastrointestinal cancers.
Late last year, Delfi—a former Fierce Medtech Fierce 15 winner—launched its blood-based lung cancer screening test to help identify people who should receive the extra attention provided by a low-dose chest CT scan and to funnel them toward confirmation of the presence of a tumor.
More recently, the Baltimore-based company welcomed a new CEO. Susan Tousi joined Delfi in early January, succeeding founder Victor Velculescu, who remains on the company's board of directors. Tousi previously spent more than 10 years at Illumina, including as chief commercial officer and chief product officer.