Strong data from previous NGAL study provides the basis for new protocol and FDA registration application
来源: Nasdaq GlobeNewswire / 14 七月 2017 10:05:04 Europe/London
An article has been published in ‘The open British Medical Journal’ containing the data that was generated from BioPorto’s multicenter prospective, blinded, observational US study in 2015.
The data was obtained from the enrollment of 245 patients and the retrospective analyses showed that NGAL predicted moderate to severe Acute Kidney Injury (AKI) and its persistence in critically ill patients with solid decision statistics using a single cutoff.
The article indicates the optimal cut off for plasma NGAL for the prediction of moderate to severe AKI among critically ill adults is 142.0 ng/mL in EDTA plasma with a sensitivity of 78.8%. For predicting persistent moderate to severe AKI, the cutoff was found at 148.3 ng/mL with a sensitivity of 84.0%.
“The data released are a big step forward for NGAL. With great confidence, NGAL can predict which patients will develop moderate to severe AKI. Most importantly, The NGAL Test™ is the only blood test on the market that has proven it can be used to detect and follow persistent AKI. These features will indeed be an advancement in the future prevention and treatment of AKI which will save thousands of life’s and millions of dollars,” says Dr. Peter McCullough, at Baylor University Medical Center in Dallas, Texas, senior author on the article.
“The data released from our prospective US clinical trial for NGAL is very encouraging for both patients potentially suffering from AKI and for BioPorto, who has recently commenced recruitment of 530 patients forming the validation data for BioPorto’s FDA application for The NGAL Test™. The previous trial established clear cutoff levels, one for diagnosing AKI and another for predicting persistent AKI, and has provided a very strong basis for our new study underway to support our registration application for the NGAL Test™ to the FDA in 2018,” said Mr. Peter Mørch Eriksen, CEO of BioPorto.
The full article can be found here.