When East meets West

SINGAPORE—Diagnostics are the name of the game in one of thelatest international industry partnerships. Vela Diagnostics, a provider ofmolecular diagnostic tests, and Thomas Jefferson University and Hospitals(Jefferson) have announced a Molecular Diagnostic Affiliation Agreement, whichlays out the stipulations for the two organizations to jointly develop,evaluate and introduce molecular diagnostic assays that will hopefully improvepatient care.

"We are enthusiastic that this collaboration will develophighly innovative diagnostic studies that provide optimal sensitivity and workflow for clinical testing," Dr. Stephen Peiper, Peter A. Herbut Professor andchair in the Department of Pathology, Anatomy & Cell Biology at ThomasJefferson University, said in a press release. "This field is at an inflectionpoint, and I anticipate that Vela will be among the leaders in unleashing thediagnostic power of next-generation sequencing."

Vela and Jefferson will work together on several projectsunder the broad fields of oncology and infectious diseases, including thedevelopment of next-generation sequencing and quantitative PCR assays withinthose indications. Jefferson will assist in developing and validation themolecular diagnostics, says Peiper, serving as a test validation site as wellas a clinical trial site in the pursuit of U.S. Food and Drug Administrationapprovals. Vela, for its part, will be responsible for seeking regulatoryapproval worldwide for whatever assays result from the collaborative work. Thepartnership represents the first time the entities have worked together. Nospecific terms were disclosed.

"Partnering with Jefferson provides Vela Diagnostics withaccess to world-recognized experts in the molecular diagnostics industry. Thisis essential for the development of high-quality molecular diagnostic assays ina dynamic clinical environment," Michael Tillmann, CEO of Vela, noted in astatement.

Vela offers a wide range of diagnostic tests, includingrespiratory, gastro and microbiology pathogen detection tests, with transplant,blood-borne, leukemia, EGFR and tropical panel tests in development. Extractionkits and consumables are also available, and the company's menu of tests isconsolidated 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 moveaggressively into next-generation sequencing and not just sitting on aconservative testing menu."

And next-generation sequencing, according to Peiper, is hereto stay.

"Next-generation sequencing is going to do for diagnosticswhat the six-gun did for the Old West; it changed lives and it made all menequal," says Peiper. "I think it's a powerful, compelling tool. It's notstraightforward to bring into a CLIA-certified, codified area, but I don'tthink it's going to go away. It's one of the few technologies where the priceis going down and the capacity is going up."

Growth for molecular diagnostics, he predicts, might be abit less uniform. Peiper foresees "a very steep climb in terms of havinginformation available and applying that information," noting that he believesthe growth will be slowed a bit by the linkage to companion diagnostics.

"I think the controversial thing is how far will it grow interms of extensive profiling of individual malignancies versus whole-exomestudies versus transcriptome studies … I personally think that the moregenome-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 afteranother Vela partnership, in which Vela Operations Pte. Ltd, the parent companyof Vela Diagnostics, inked a technology license agreement with SwiftBiosciences Inc. Under the terms of the agreement, Vela gains non-exclusiverights to use Swift's myT Primer technology in its own real-time quantitativePCR-based in-vitro diagnostic productsfor detecting somatic mutations in human cancer.