Corvista, Mayo Clinic team up to study non-invasive PH diagnostic test
Study will assess whether Corvista-PH improves detection and referrals
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Corvista Health will collaborate with Mayo Clinic to evaluate whether its non-invasive Corvista-PH test can improve the detection, risk stratification, and referral accuracy for people with suspected pulmonary hypertension (PH).
“Collaborating with Mayo Clinic represents a defining moment for CorVista and for the advancement of pulmonary hypertension diagnostics,” Adrian Lam, president and CEO of Corvista Health, said in a company press release. “By combining Mayo’s research capabilities with CorVista’s next-generation diagnostic platform, we seek to fundamentally improve how pulmonary hypertension is identified in our efforts to move the field closer to earlier detection, more accurate referral, and better outcomes for patients.”
PH diagnosis can be delayed by overlapping symptoms
PH is a progressive condition characterized by elevated pressure in the pulmonary arteries, the blood vessels that carry blood from the heart to the lungs. Such high pressure means the heart has to work harder to pump blood, potentially leading to heart failure.
Because its symptoms, including shortness of breath, fatigue, and chest discomfort, overlap with those of many other heart and lung conditions, patients often undergo prolonged diagnostic journeys. Earlier, more accurate identification remains a pressing need in PH.
The Corvista-PH test, part of the Corvista System, analyzes subtle patterns in signals related to the heart and the mechanics of blood flow. The analysis is performed using machine-learning algorithms, which are computer models trained on large patient datasets to recognize patterns associated with disease.
The test is non-invasive and requires no radiation, contrast agents, injections, fasting, or exercise. It is designed to be administered at the point of care, meaning results can be available to the physician and patient during the same visit.
In 2024, the Corvista System was cleared by the U.S. Food and Drug Administration (FDA) to help detect PH. Data from the IDENTIFY-PH study (NCT04031989) and the IDENTIFY study (NCT03864081) supported its use in PH, with a prior analysis reporting it was at least 93% accurate at detecting the condition. The Corvista System is also cleared to aid in detecting coronary artery disease, a condition that affects the blood vessels supplying the heart.
Corvista-PH is being studied with standard diagnostic approaches
The Corvista-PH test received breakthrough device designation from the FDA, a status intended to expedite the development and review of devices that have the potential to provide more effective diagnosis of serious conditions. So far, the technology has been validated through clinical trials involving more than 11,000 patients, according to Corvista Health.
The planned observational study will evaluate whether the Corvista-PH test, used alongside current standard diagnostic approaches, can improve the detection and referral of patients with suspected PH.
Researchers will draw on referral patterns, biomarker correlations, and invasive diagnostic confirmation to build a more comprehensive body of evidence for earlier and more accurate point-of-care detection.
According to Corvista, the collaboration reflects broader interest in whether advanced signal-based diagnostics and artificial intelligence can help address persistent gaps in cardiovascular disease detection, particularly for conditions such as PH.
Mayo Clinic holds a financial interest in the technology and has indicated that any revenue it receives will support its not-for-profit mission in patient care, education, and research.
