05 Nov Biotech Daily – “4DX: ‘XV BEATS PFT, CT FOR LUNG HEALTH’”
From Biotech Daily – released Friday, November 1, 2019
4DX says a 32-patient, 13-month study shows that its XV technology is superior to “gold standard pulmonary diagnostics” to measure lung health.
4DX said the study, titled ‘Novel x-ray velocimetry based quantitative regional lung function analysis to assess risk of radiation-induced pneumonitis and pulmonary fibrosis’, was published in the journal Chest, with an abstract available at: https://journal.chestnet.org/article/S0012-3692(19)31813-6/fulltext.
4DX said the results were presented by principal investigator Dr Stephen Shiao at the American College of Chest Physicians meeting in New Orleans on October 22, 2019.
The company said the trial compared XV Technology to pulmonary function tests (PFT) at four time points and to computed tomography (CT) tests at one time point
4DX said it found that XV had “excellent” reliability and repeatability and correlated with PFT and CT tests.
The company said both ventilation heterogeneity and ventilation defect percent of XV were statistically significant when correlated with forced expiratory volume in one second (FEV1) and forced vital capacity.
4DX said XV was superior to PFT and CT tests in detecting and locating loss of lung function either as a result of disease or as part of off-target effects of treatment.
The company said XV’s increased sensitivity and richer data resulted in increased predictive power, greater certainty than PFT testing and the identification of subtle changes not reflected in PFT data.
4DX said clinicians “unanimously agreed” that XV report data was “clinically meaningful” over CT and PFT data following the results of the trial and an expert clinical panel, which reviewed XV.
4DX chief executive officer and co-author of the article Dr Andreas Fouras said that “exhaustive laboratory testing over the past 10 years has shown the capabilities of XV Technology, and it is extremely exciting to see the same capability borne out in a clinical trial”.
4DX said the results would be incorporated into its 510(k) application to the US Food and Drug Administration for market clearance, which it expected to lodge by the end of 2019.
The company said it submitted a pre-submission enquiry with the FDA for XV in 2018.
4DX is a public unlisted company.