When East meets West
SINGAPORE—Diagnostics are the name of the game in one of the latest international industry partnerships. Vela Diagnostics, a provider of molecular diagnostic tests, and Thomas Jefferson University and Hospitals (Jefferson) have announced a Molecular Diagnostic Affiliation Agreement, which lays out the stipulations for the two organizations to jointly develop, evaluate and introduce molecular diagnostic assays that will hopefully improve patient care.
"We are enthusiastic that this collaboration will develop highly innovative diagnostic studies that provide optimal sensitivity and work flow for clinical testing," Dr. Stephen Peiper, Peter A. Herbut Professor and chair in the Department of Pathology, Anatomy & Cell Biology at Thomas Jefferson University, said in a press release. "This field is at an inflection point, and I anticipate that Vela will be among the leaders in unleashing the diagnostic power of next-generation sequencing."
Vela and Jefferson will work together on several projects under the broad fields of oncology and infectious diseases, including the development of next-generation sequencing and quantitative PCR assays within those indications. Jefferson will assist in developing and validation the molecular diagnostics, says Peiper, serving as a test validation site as well as a clinical trial site in the pursuit of U.S. Food and Drug Administration approvals. Vela, for its part, will be responsible for seeking regulatory approval worldwide for whatever assays result from the collaborative work. The partnership represents the first time the entities have worked together. No specific terms were disclosed.
"Partnering with Jefferson provides Vela Diagnostics with access to world-recognized experts in the molecular diagnostics industry. This is essential for the development of high-quality molecular diagnostic assays in a dynamic clinical environment," Michael Tillmann, CEO of Vela, noted in a statement.
Vela offers a wide range of diagnostic tests, including respiratory, gastro and microbiology pathogen detection tests, with transplant, blood-borne, leukemia, EGFR and tropical panel tests in development. Extraction kits and consumables are also available, and the company's menu of tests is consolidated on Sentosa, its automated workflow system.
Vela represented an attractive partner for a few reasons, says Peiper. The company has very strong leadership, he notes, and is "forward-looking in terms of new opportunities" and "looking to move aggressively into next-generation sequencing and not just sitting on a conservative testing menu."
And next-generation sequencing, according to Peiper, is here to stay.
"Next-generation sequencing is going to do for diagnostics what the six-gun did for the Old West; it changed lives and it made all men equal," says Peiper. "I think it's a powerful, compelling tool. It's not straightforward to bring into a CLIA-certified, codified area, but I don't think it's going to go away. It's one of the few technologies where the price is going down and the capacity is going up."
Growth for molecular diagnostics, he predicts, might be a bit less uniform. Peiper foresees "a very steep climb in terms of having information available and applying that information," noting that he believes the growth will be slowed a bit by the linkage to companion diagnostics.
"I think the controversial thing is how far will it grow in terms of extensive profiling of individual malignancies versus whole-exome studies versus transcriptome studies … I personally think that the more genome-wide studies will not be implemented rapidly, but I think increasingly, small-scale and intermediate-scale profiling will," says Peiper.
This agreement comes a little more than a month after another Vela partnership, in which Vela Operations Pte. Ltd, the parent company of Vela Diagnostics, inked a technology license agreement with Swift Biosciences Inc. Under the terms of the agreement, Vela gains non-exclusive rights to use Swift's myT Primer technology in its own real-time quantitative PCR-based in-vitro diagnostic products for detecting somatic mutations in human cancer.