NEW YORK – Nvigen, a developer of nanoparticle-enabled assays for personalized healthcare applications, presented data last week at the San Antonio Breast Cancer Symposium showing that its Nvigen X Cancer Precision Profiling assay accurately monitors dynamic changes in circulating tumor DNA, or ctDNA.
The company, founded in 2011, now plans to establish a CLIA lab in the Bay Area next year to offer its research-use-only assay as an LDT. Pending further investment funding, Nvigen also plans to complete a 150-person validation study of its platforms, followed by an approximately 500-participant study to pursue US Food and Drug Administration approval for its assay and move it into the clinical setting.
Nvigen X consists of a nanoparticle-enabled DNA extraction method coupled to a 32-gene panel covering 144 kb of genetic regions relevant to several cancers. The platform uses a hybridization capture approach to isolate DNA from lysed cells in blood, saliva, and pleural fluid samples using the company's MagVigen antibody-coated magnetic nanoparticles. The nanoparticles are controlled via a magnetic field gradient and the isolated DNA can be applied to various downstream assays such as next-generation sequencing.
Importantly, the assay is designed to capture both known and novel mutations, making it possible to scan for new mutations as they arise.
In a poster presented at SABCS, Nvigen showed performance metrics data of Nvigen X and a case study from an ongoing 150-person pilot study of the assay's performance in breast cancer patients.
At 10 ng of input material and at 440X unique coverage, the assay showed 92 percent sensitivity, detecting 18 of 24 control variants — similar, they noted, to the best-performing assays in a Nature Biotechnology paper published earlier this year that evaluated analytical validity of circulating tumor DNA sequencing assays for precision oncology.
The case study selected for presentation compared Nvigen X to an unnamed commercial liquid biopsy in a 58-year-old woman with breast cancer that had metastasized to the lung. The assays showed 100 percent concordance on potentially actionable and biologically relevant genes covered by both panels before and after treatment. Nvigen reported that its assay was able to detect additional ESR1 and PIK3CA mutations, which it intends to evaluate further in ongoing experiments. The company anticipates being able to report more results from the ongoing pilot study within the coming year.
Nvigen is currently scaling up to a 180-gene panel, covering breast, lung, colorectal, and pancreatic cancers. In addition to known cancer-related genes, this panel will include "some exploratory immune, neuronal, and metabolic indicators to take advantage of the high NGS data efficiency of our ctDNA assay, to better decipher cancer biology," Aihua Fu, the company's CEO, said in an interview.
"We can also customize the panel to make detection of various cancers benefit from our highly sensitive high NGS data efficiency assays" Fu said.
Rather than directly compare Nvigen X to other assays in the pilot study, the company relied instead on data in published literature. From this, Nvigen estimated that its assay was more efficient in terms of paired-end reads needed for 1X coverage. This calculation resulted in a data efficiency of 1.36 for Nvigen X compared to 7.35 for the Avenio Surveillance assay from Roche, as calculated from results found in a 2020 study.
Nvigen's liquid biopsy enters a competitive market driven by rising numbers of cancer patients and an increased demand for minimally invasive detection methods that can help monitor and personalize treatments.
The company plans to automate the Nvigen X workflow and has been looking into options from several automation companies.
"Nvigen does not have plans to develop its own instrumentation for the Nvigen X workflow," Fu said. "Rather, Nvigen is using [commercially available] automation instrumentation or [will partner] with other instrumentation companies, should there be more instrumentation development needed to support specific Nvigen X assay features."
Nvigen has no plans to seek a European CE mark but it does plan to follow the pilot study with a 500-person registrational study in support of FDA clearance. While more details of that study are forthcoming, Fu said that it will take place in the US, focus on breast cancer patients undergoing active treatment, and compare Nvigen X to other commercial ctDNA assays, such as those from Guardant Health, Foundation Medicine, Tempus, and others.
Nvigen currently has seven employees and has raised $8 million in funding, while continuing to seek further investments.