October 2019 News Briefs

AMA Grants CPT-PLA Code for KidneyIntelX™

The American Medical Association (AMA) has granted a CPT® (Current Procedural Terminology) Proprietary Laboratory Analyses (PLA) Code for KidneyIntelX™, the lead product from RenalytixAI. The new code, 0105U, has been approved and published by the AMA CPT Editorial Panel, effective October 1, 2019.

According to a press release from RenalytixAI, a payment rate for the new code will be established for Medicare patients through the 2019 Clinical Lab Fee Schedule Annual Public Meeting process. RenalytixAI will provide comments and a recommendation on the appropriate basis for establishing a national Medicare price for this new PCT code.

Michael J. Donavan, PhD, MD, chief medical officer at RenalytixAI, said, “This is an important step as we prepare for KidneyIntelX’s scaled rollout in the United States. A CPT code is instrumental in obtaining insurance coverage and reimbursement, and will increase access to KidneyIntelX testing results for patients with chronic kidney disease.”

CPT terminology is the most widely accepted medical nomenclature in the United States. PLA codes, recently added to the CPT Code set, are alpha-numeric CPT codes with a corresponding descriptor for labs or manufacturers who want to identify their test more specifically.

KidneyIntelX is designed to improve identification and clinical management of patients with type 2 diabetes and rapidly progressing kidney disease. KidneyIntelX utilizes machine learning algorithms to assess a combination of predictive blood-based biomarkers, including sTNFR1, sTNFR2, and KIM1, and features from a patient’s electronic health record, according to the press release.

Fresenius Invests in BioIntelliSense

In a recent press release, Fresenius Medical Care North America announced a major investment in BioIntelliSense, a Denver-based company that is developing a medical grade data services platform for continuous health monitoring, predictive analytics, and algorithmic clinical insights. According to a press release from Fresenius, the investment was completed through the Fresenius Medical Care Ventures division that invests in early stage companies that develop products, technologies, and therapies that will result in significant value for patients and the healthcare system.

Bill Valle, CEO of Fresenius Medical Care North America, said, “We are committed to helping more people living with chronic kidney disease through earlier interventions and are proud to invest in a company that is leading innovation in remote health sensors and services that we believe will help us accelerate change, further improve quality care, and slow progression of chronic kidney disease. We made this strategic investment in BioIntelliSense to enable our medical staff to more efficiently and effectively continuously monitor patients, facilitating precise and timely interventions and reducing cost to the system. We are pleased that the Centers for Medicare & Medicaid Services recognizes the benefit to patients and has provided separate reimbursement to fairly compensate for the cost of the devices and physician interpretation of the captured data and analytics.”

Founder and CEO of BioIntelliSense, James Mault, MD, said, “We are at the inception of a remarkable new era in healthcare that will employ novel sensor technologies to capture remote patient data and generate cost-effective clinical intelligence. Chronic kidney disease patients have complex health challenges and BioIntelliSense is both honored and excited to work closely with Fresenius Medical Care North America in developing scalable health monitoring solutions that might benefit this important patient population.”

RenalytixAI Names Thomas McLain to Leadership Team

RenalytixAI has announced the appointment of Thomas McLain as president and chief commercial officer. According to a press release from RenalytixAI, Mr. McLain will be responsible for heading the commercial program for KidneyIntelX™, focusing on establishing national and international clinical adoption and reimbursement. RenalytixAI develops artificial intelligence-enabled diagnostics for kidney disease.

Most recently, Mr. McLain led business and commercial strategy for the Exosome Diagnostics’ ExosomeDx® Prostate (Intelliscore) test, a liquid biopsy diagnostic for identifying men at increased risk for aggressive or high grade prostate cancer. Mr. McLain has been recognized as a leading voice for progressive diagnostic reimbursement strategy, including innovative collaborations and programs with private insurance groups to encourage collection of outcome and health economic data leading to accelerated clinical adoption and positive coverage determinations.

James McCullough, chief executive officer at RenalytixAI, said, “I am honored to welcome Tom to the RenalytixAI leadership team. Tom’s deep understanding of diagnostic product commercialization, healthcare markets, and reimbursement will be a great asset to our company.”

AI and Estimations of GFR

Ultrasound imaging of the kidney is considered optimal in clinical practice due to its safety, convenience, and affordability. However, according to Chin-Chi Kuo, MD, PhD, and colleagues in Taiwan, the high subjective variability in image acquisition and interpretation makes incorporating  experience-based prediction into standardized practice difficult. The researchers developed an artificial intelligence (AI) noninvasive tool to predict kidney function using estimated glomerular filtration rates (eGFR) based on serum creatinine concentrations.

The researchers tested the algorithm in a large registry-based cohort of patients with CKD. Results were reported online in Nature Partner Journals/Digital Medicine [npj Digital Medicine, volume 2, Article number:29 (2019)].

For classification of eGFR with a threshold of 60 mL/min/1.73 m2, the model achieved an overall accuracy of 85.6%, which was higher than that of experienced nephrologists. The area under the receiving operating characteristic curve was 0.904. Attained specificity was up to 92.1%, indicating the effectiveness of the deep learning algorithm for assessing CKD using ultrasound images. However, the sensitivity was only moderate (~60.7%).

The relationship between artificial intelligence (AI) and estimates of eGFR based on serum creatinine was strong, indicated by a Pearson correlation coefficient of 0.741.

In summary, the researchers said, “Our model is the first fundamental step toward realizing the potential of transforming kidney ultrasound imaging into an effective, real-time, distant screening tool. AI-GFR estimation offers the possibility of noninvasive assessment of kidney function, a key goal of AI-powered functional automation in clinical practice.”

Positive Top-Line Results from CONFIRM Study

In late August, Mallinckrodt announced positive top-line results from the phase 3 CONFIRM study designed to evaluate the efficacy and safety of terlipressin in a cohort of 300 adults with hepatorenal syndrome type 1 (HRS-1). According to a press release from Mallinckrodt, the study met the primary end point of verified HRS-1 reversal, defined as (1) improvement in renal function; (2) avoidance of dialysis; and (3) short-term survival. Data will be presented at an upcoming medical meeting.

There are no approved drug therapies for HRS-1 currently in the United States or Canada; HRS-1 is estimated to affect 30,000 to 40,000 patients in the United States annually. Mallinckrodt plans to submit a New Drug Application to the US FDA in early 2020.

Lead investigator Arun Sanyal, MD, said, “The initial results from the phase 3 CONFIRM study are very encouraging in that they demonstrate terlipressin reversed the course of HRS-1 as measured by improvement in renal function, avoidance of dialysis, and short-term survival. The study met nearly all of the pre-specified secondary end points. HRS-1 is a life-threatening disease that is extremely difficult to treat. We anticipate the complete results will continue to help inform the effectiveness and safety profile of terlipressin in the patient population with urgent unmet medical needs.”

Diagnosing Kidney Rejection before Clinical Signs of Kidney Damage

RenalytixAI has announced positive study results of a study that is part of a continuing research program from the FractalDx kidney transplant diagnostic portfolio. RenalytixAI is a developer of artificial intelligence-enabled clinical diagnostics for kidney disease.

According to a press release from RenalytixAI, the results demonstrate a blood test can diagnose kidney rejection before clinical signs of kidney damage and may be use to tailor immunosuppressive therapy. The post-transplant diagnostic, FractalDx ACR, is the second of the candidate test from the FractalDx portfolio licenses by RenalytixAI from the Ichan School of Medicine at Mount Sinai, New York, New York.

Barbara Murphy, MD, the lead investigator for the two studies, said, “In transplant, the inability to accurately identify rejection before any clinical signs appear has a significant impact on therapeutic management and long-term viability of the transplanted kidney. These study results demonstrate that non-invasive measurements may be used to stratify patients immunologically so that immunosuppressive therapy can be tailored to the individual patient needs.”

RenalytixAI plans to initiate larger scale clinical validation of the Fractal Serial Dx for diagnosis of sub-clinical acute (or underlying) rejection as early as the last part of 2019, with formal launch as a laboratory developed test through its New York City clinical laboratory expected in 2020.

Otsuka Announces Resources for Physicians and Patients

Otsuka America Pharmaceutical, Inc., has launched two websites for patients and physicians seeking resources and information on polycystic kidney disease (PKD). PKDNetwork.org is sourced by nephrology experts and is aimed at physicians treating patients with PDK, including autosomal dominant PDK (ADPKD). The site includes announcements of educational events and other resources for clinicians, as well as a PDK disease progression simulator intended to enhance physician-patient conversations regarding disease prognosis and symptoms.

PKDinfo.com is a patient-focused website that houses information on ADPKD including disease management, seeking help from physicians, and other professional resources for patients and caregivers.