Info & Opinion
February 19, 2019
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
Cardiology diagnostics technology firm NewCardio hopes to transform a key sector of the industry: the way cardiac safety is monitored in clinical trials. They’re not there yet, but the company has a formidable executive roster.
Four-year-old NewCardio—hard at work on roll-out plans for multiple products—is small. It has just 10 employees and is traded as a penny stock on the over-the-counter securities market (OTCBB: NWCI).
But president Vincent Renz has a serious background in clinical trial technology. He was formerly chief operating officer of ClinPhone and, before that, chief technology officer of eResearch Technology, the leader in managing electrocardiograms (ECGs) in industry-sponsored research.
The plan at NewCardio is to show the contract research organization (CRO) and drug sponsor market software called QTinno. It allows the automated analysis of QT intervals and other ECG markers for cardiac safety assessment trials.
As readers know, QT testing has been visible for years. Unexpected cardiac toxicity has become the most common cause of withdrawal from the market—as well as a top reason for more limited indications for drugs already on the market. The FDA has a well-known mandate that all new drugs go through a thorough QT (TQT) study.
The first phase of QTinno’s rollout, planned for this summer, relates to TQT and Phase I trials. The company’s software processes ECGs gathered the old-fashioned way—via standard 12-lead electrodes—into a three-dimensional representation of cardiac electrical activity over time. It includes information from the entire heart, measuring and adjudicating QT intervals and other measures of electrical activity. It then assesses each automated reading for the quality and likelihood of an error, and, based on user-defined parameters, presents ECGs that should be reviewed by humans. ECG files are delivered in FDA XML format—or any other format the user needs.
No other company offers the same levels of automation or detailed insight into the heart, says Renz. His assessment is that most of NewCardio’s competitors (among them iCardiac Technologies and Monebo Technologies) are still using two-dimensional representations. Other firms are trying to develop new ways to collect ECG data. Renz believes that sponsors, CROs, hospitals and ambulance companies are more likely to adopt a new product if it allows them to keep doing things they way they always have—except with data processed in a faster, more accurate way that ensures reproducibility and cost savings.
After launching in the clinical trials space, the company’s plan is to enter the hospital and ambulance markets. Why try clinical trials first? “Clinical research has readily identified problems that were searching for solutions,” says Renz. And the time to market was faster, he adds. QTinno has NewCardio poised to offer new biomarkers that could potentially complement the industry’s dominant cardiac biomarker: QT interval prolongation.
As familiar as it is, Renz says, QT interval prolongation is not especially reliable. It only detects arrhythmias. Those add up to just six to eight percent of cardiac disease, he says. Another issue: a standard ECG just measures electrical activity on the front surface of the heart; NewCardio’s product will measure activity throughout the organ, increasing specificity and the ability to properly diagnose, Renz says.
To develop the science and regulatory road map, Renz and the NewCardio team have been working closely with the Cardiac Safety Research Consortium (CSRC), a three-year-old collaboration of medical product safety experts from academia, industry, and the FDA. CSRC was formed in response to the Critical Path Initiative, the FDA’s effort to modernize the drug development process.
The company has been eager to prove the software is better than slower, more expensive human ECG interpretation. In three separate early-phase studies, comprising 11,525 ECGs, the automated ECG interpretations from the NewCardio technology have been compared to both manual readings and semi-automated ones. “The QTinno fully automated results compared favorably to the manual and semi-automatic approaches with a high degree of precision with low intrinsic variability,” says Renz. “We have effectively completed the clinical validation required for market launch.” Which is not to say that sponsors may have additional validation that NewCardio will be happy to undertake.
NewCardio, Renz says, continues to work with partners to validate the results of QTinno, including the CSRC, which has agreed to provide ECG data from a previously conducted trial to compare to the results from QTinno. “We believe the analysis of the results of this exercise will help convince industry that the NewCardio solution is the new standard for cardiac safety testing,” he says. Here’s a news release on one such project.
Core Lab Angle
NewCardio plans to charge future QTinno clients in a rather untraditional way: CROs or sponsors will pay on a per-ECG basis, with zero capital investment. The firm will try to have clients commit to a certain number of studies per year.
The value proposition to CROs conducting cardiac safety trials, Renz says, is that they will no longer have to farm out such work to a core lab. That could affect a wide cross-section of services companies that will suddenly be able to do their own safety testing in-house. The cost savings could be substantial. If a typical Phase I QT trial today costs perhaps $1.2 million, QTinno might reduce the bill to around $250,000. “If a CRO then wants to mark it up 50 percent, they can do that, make money and still pass along some of the savings to the sponsor,” Renz notes.
Renz says NewCardio is in “aggressive discussions” with a handful of the largest CROs. One CRO has the company processing some ECGs now as a sort of audition. A large pharma company is also about to hand over similar data for the same purpose. This year, NewCardio aims to sign up two or three customers (CROs or sponsors) running perhaps six to eight trials with 14,000 and 18,000 ECGs per trial. Next year, it will get more aggressive.
NewCardio is based in Silicon Valley’s Santa Clara, Calif., with another office in Princeton, N.J. In addition to its 10 employees, it has another eight rather important consultants in Belgrade, Serbia. Three of them are the company’s three founders—nuclear physicists who began tinkering with automated algorithms for ECG.
Key executives at the firm include Mark Knoll, the former chief technology officer at St. Jude Medical; Ihor Gussack, executive editor of the Journal of Electrocardiology; and Joe Esposito, the former CEO of eResearch Technology. The full team can be found here. Between them, the company’s executives have hundreds of patents. These gentlemen didn’t stumble upon ECGs yesterday when visiting their family doctors.
The NewCardio ramp-up is ambitious. The company’s technology will have to survive additional clinical and regulatory scrutiny. But a new approach is what the market needs, says Renz: “Ultimately, our objective is to add value to each and every one of the more than 250 million ECGs taken annually, as well as replace other more costly procedures with the ECG.”
—by Suz Redfearn