News Briefs

Nonagen Bioscience is making news! Read highlights from our most recent press releases.

Nonagen Receives Medicare Payment Rate for the Oncuria Bladder Cancer Tests

January 10, 2024

Los Angeles, California – Nonagen Bioscience Corp, the developer of the urine-based multiplex immunoassay for the detection and management of bladder cancer, announced today that the Centers for Medicare and Medicaid Services (CMS) have decided on the payment rate for Oncuria-Detect, Oncuria-Monitor and Oncuria-Predict, Laboratory Diagnostic Tests (LDTs). The rate became effective on Jan. 1, 2024. 

“This marks a significant milestone in advancing bladder cancer care and underscores the pivotal role liquid biopsies play in transforming cancer care,” said Charles J. Rosser, CEO and Co-Founder of Nonagen Bioscience. “Our suite of Oncuria bladder cancer tests is just one among only a handful of bladder cancer tests that have secured payment rates, and as the market continues to grow, this decision serves as a promising indicator for both Nonagen Bioscience and the broader spectrum of bladder diagnostic companies.”

This decision by CMS establishes a payment rate for Oncuria-Detect to evaluate patients with hematuria for bladder cancer, for Oncuria-Monitor to evaluate patients with a history of bladder cancer for disease recurrence, and for Oncuria-Predict to evaluate patients who are being considered for intravesical BCG treatment. The multianalyte assays with algorithmic analysis (MAAA) biomarker tests leverage unique algorithms for each test that assesses a bladder cancer associated protein signature from a single voided urine sample.

Nonagen Bioscience and Human Metabolomics Institute, Inc. sign Exclusive Agreement to License a Novel Diagnostic Test for the Noninvasive Detection of Liver Fibrosis

AUGUST 14, 2023

Los Angeles, CA and Shenzhen, China—Nonagen Bioscience Corporation, a US-based biotech company dedicated to discovering and developing breakthrough diagnostics for human diseases, and Human Metabolomics Institute, Inc. (HMI), a China-based biotech company specializing in discovery of clinically relevant metabolites, have agreed to an exclusive licensing agreement for HMI’s liver fibrosis/cancer detection technology. As part of the agreement, Nonagen will be seeking clinical partners to enable widespread healthcare provider access to a noninvasive liver fibrosis detection test throughout the United States and select countries abroad.

With the incidence of non-alcohol–associated liver disease and chronic hepatitis C increasing in the United States by 50% and 200%, respectively, over the past 2 decades, liver fibrosis, a sequela of these conditions, is a major problem in the United States. Furthermore, liver fibrosis is on the clinical spectrum leading to cirrhosis and liver cancer.

“Liver biopsy, a highly invasive procedure, is currently the gold standard for evaluating the presence and degree of liver fibrosis. There are also currently no extensively validated, robust noninvasive tests to detect and assess the severity of liver fibrosis for treatment selection and monitoring. We are looking forward to bringing HMI’s robust, noninvasive test for the detection of liver fibrosis to the US market,” said Charles J. Rosser, MD, CEO of Nonagen Bioscience. “We see this as the first of many possible tests on which we can partner with HMI to bring to the market.”

“We are excited to be working with Nonagen to take our best-in-class test for detection of liver fibrosis to the market,” said Prof. Wei Jia, CEO of HMI. “Charles and his team have the experience and network to help bring this test to the US market and make a clinically meaningful impact for patients suffering from liver fibrosis.”

Nonagen Bioscience announces Timothy “TJ” Johnson as Executive Chair of Nonagen Bioscience Corporation

April 27, 2023

Los Angeles, CA—Nonagen Bioscience, a cancer diagnostics company, today announced that Timothy “TJ” Johnson has been named Executive Chair of the Nonagen Bioscience Corporation. Mr. Johnson has nearly 30 years of executive leadership experience in the life sciences industry.

In his new role, Mr. Johnson will provide strategic and operational direction, collaborate with Nonagen’s CEO and senior management on research and commercialization efforts, and advise on all company ventures and strategic partnerships.

“We’re thrilled to welcome TJ and his effective style of leadership,” said Nonagen Bioscience CEO Charles Joel Rosser, MD, MBA. “Not only does he have an impressive track record of success in managing companies like ours, but he also shares our passion to bring science to bear in the fight against cancer.” 

Mr. Johnson has held C-suite and executive-level leadership positions for several life sciences companies, including Ventana Medical Systems, Inc., a medical diagnostics company that was acquired by Roche in 2007. He spent more than 12 years as president and CEO and as a member of the board of directors at HTG Molecular Diagnostics, including leading a successful IPO in 2015. Previously, he had a career that spanned more than 10 years at Hillenbrand Industries, Inc. Mr. Johnson holds a bachelor’s degree in business from Indiana University.

“Nonagen Bioscience is breaking new ground in the field of cancer diagnostics with its Oncuria® liquid biopsy for the early detection and management of bladder cancer,” said Mr. Johnson. “I look forward to working with this talented team to bring noninvasive diagnostic tests to healthcare providers and their patients.”

DiaCarta Completes Oncuria® Validation Study with Nonagen Bioscience

January 5, 2023

Pleasanton, CA and Los Angeles, CA—DiaCarta, Ltd. (“DiaCarta), a precision molecular diagnostics company, and Nonagen Bioscience, a cancer diagnostics company, announced today the successful completion of the validation study of Oncuria® multiplex bladder cancer immunoassay as a laboratory developed test (“LDT”). DiaCarta also announced that it has begun receiving patient urine samples for testing in its CLIA certified lab in Pleasanton, California. 

Oncuria is a first-of-its-kind multiplex protein-based urine test to provide early and accurate detection, therapy choice, and disease monitoring of bladder cancer. Oncuria detects concentrations of 10 proteins associated with bladder cancer in urine samples. In clinical studies, Oncuria was shown to have 93% sensitivity and 93% specificity for detecting bladder cancer. Additionally, Oncuria has demonstrated consistent sensitivity and specificity across bladder cancer tumor grades and stages. Oncuria’s high level of accuracy is especially meaningful for detecting low-grade tumors, which is an area of high unmet need in bladder cancer management.

The American Medical Association has issued dedicated Current Procedural Terminology (CPT®) Proprietary Laboratory Analyses (PLA) codes—Oncuria Detect 0365U, Oncuria Monitor 0366U, and Oncuria Predict 0367U—which are effective as of January 1, 2023.

Oncuria received Breakthrough Device Designation from the US Food and Drug Administration (FDA) in September 2021 for predicting responses to Bacillus Calmette-Guérin (BCG) therapy, a first-line treatment for bladder cancer. Oncuria’s predictive capability is noteworthy given the current shortage of BCG.

“The results of our collaborative validation study with Nonagen Bioscience are exciting and showcase Oncuria as a truly novel test that can be used as an aid for the early diagnosis of bladder cancer, monitoring of tumor recurrence, and predicting responses to therapy,” said Aiguo (Adam) Zhang PhD, President & CEO of DiaCarta.

“We are thrilled to be collaborating with DiaCarta to give doctors a new, highly accurate, and versatile diagnostic tool to manage bladder cancer,” added Charles Joel Rosser, MD, MBA, chief executive officer at Nonagen Bioscience.

Nonagen Bioscience announces CE mark for Oncuria® Bladder Cancer diagnostic

June 16, 2022

Los Angeles, CA—Nonagen Bioscience, a cancer diagnostics company, today announced CE marking for its Oncuria® immunoassay for bladder cancer.

Oncuria is the first-of-its-kind multiplex urine test for the quantitative detection of 10 biomarkers in urine that are associated with the presence of bladder cancer.

Oncuria now bears the CE marking and is registered under the EU In Vitro Diagnostic Directive (IVDD), EU Directive 98/79/EC, which allows Nonagen to sell the diagnostic in the European market.

“The CE mark demonstrates the quality of the Oncuria test, which reflects years of rigorous clinical development by an exceptional team,” said Charles J. Rosser, MD, MBA, chief executive officer and chief medical officer at Nonagen Bioscience. “This is a significant first step on the path to the global commercialization of Oncuria.”

Nonagen Bioscience is targeting a United States launch of Oncuria in the last quarter of 2022, followed soon after by a European launch of Oncuria as an IVDD. Pending US Food and Drug Administration approval, Nonagen Bioscience intends to make Oncuria available as an in vitro diagnostic.   

Nonagen Bioscience announces Wayne Hogrefe, PhD as chief operating officer (COO)

June 7, 2022

Los Angeles, CA—Nonagen Bioscience, a cancer diagnostics company, today announced that Wayne Hogrefe, PhD, has been named COO. Dr. Hogrefe has more than 30 years of experience in the diagnostics industry, including research and assay development for vaccine responses, vector-borne diseases, viral pathogens, and emerging pathogens. 

In his new role, Dr. Hogrefe will oversee the launch of Nonagen Bioscience’s lead diagnostic, Oncuria®, as a laboratory developed test (LDT) for bladder cancer by the end of 2022. He will also work closely with the US Food and Drug Administration (FDA) as Nonagen seeks FDA approval of Oncuria as an in vitro diagnostic (IVD). 

“Wayne is the perfect leader to help us bring our first diagnostic to market,” said Nonagen Bioscience CEO Charles Joel Rosser, MD, MBA. “His extensive experience in diagnostics and his business development skills will ensure a smooth rollout of Oncuria as a laboratory developed test later this year.”

Dr. Hogrefe holds several patents and has had more than 30 peer-reviewed articles published. He has held leadership positions at Q2 Solutions, St. Luke’s Hospital in Cleveland, Ohio, Focus Diagnostics, and Quest Diagnostics. Dr. Hogrefe is an emeritus diplomate of the American Board of Medical Laboratory Immunology.

“I’m excited to step into the COO role at this important time for the company,” said Dr. Hogrefe. “Oncuria is a novel multiplex immunoassay for the quantitative detection of biomarkers in urine that are associated with the presence of bladder cancer, and it has the potential to make a real difference in the way bladder cancer is diagnosed and managed.”

Nonagen Bioscience Adds Drs. Hogrefe and Hodges to Board of Directors

FEbruary 27, 2022

LOS ANGELES, CA—Today, Nonagen Bioscience Corporation is delighted to welcome Drs. Wayne Hogrefe and Steve Hodges to our Board of Directors (BOD). Dr. Hogrefe has over 25 years of industry experience as it relates to diagnostics, previously working at Focus Diagnostics and Q2 Solutions. Dr. Hodges, Associate Professor of Urology at Wake Forest University School of Medicine has a thriving clinical practice and has spun off three companies—Sneez, Applied Catheter Technologies Inc, and Akesian Health Sciences Inc). They join Charles Rosser (CEO) and Dave Mori (CBO) on the BOD, which advises the management team on all aspects of the business leading to the production of state of the art products and driving overall valuation.

“We are extremely fortunate to land both Drs. Hogrefe and Hodges to work with us at this critical stage of our development.” said Dr. Rosser.

Nonagen Bioscience looks to Peregrine Market Access to lead the commercialization of innovative bladder cancer diagnostic test

January 28, 2022

SARATOGA SPRINGS, NY and LOS ANGELES, CA—Peregrine Market Access, a leading life science commercialization partner, has been selected by Nonagen Bioscience to become its contract commercialization organization for Oncuria, a breakthrough bladder cancer diagnostic test that is being developed to aid in detection, therapy choice, and disease monitoring. Under a multiyear, multimillion dollar agreement, Peregrine Market Access will lead the United States launch of Oncuria.

“After an extensive search for the right commercialization partner, we are confident that Peregrine Market Access is the optimal choice to help us succeed in bringing Oncuria™ to market,” explains Nonagen Bioscience CEO Charles Joel Rosser, MD, MBA. “John Guarino and his world-class team not only have the experience and expertise to help us navigate the complexities of launching a novel device in the United States, but they also share our passion to improve the lives of people living with chronic, life-threatening conditions.” Nonagen Bioscience’s Oncuria is a cutting-edge multiplex immunoassay that measures 10 protein biomarkers associated with bladder cancer using easy-to-collect urine samples. “We are excited to become an extension of the team at Nonagen Bioscience to advance a game-changing immunoassay in the fight against bladder cancer,” says John Guarino, president and founder of Peregrine Market Access. “This partnership with Nonagen Bioscience will enable Peregrine to showcase the breadth and depth of our capabilities and, most importantly, to contribute to the noble work of saving people’s lives through timely intervention.”

Nonagen Bioscience Granted FDA Breakthrough Device Designation

September 28, 2021

LOS ANGELES, CA—Nonagen Bioscience Corp, pioneers in the development of liquid biopsy tests for the detection of human cancers, today announced Oncuria, their non-invasive bladder cancer test capable of predicting response to therapy, has been granted U.S. Food and Drug Administration (FDA) Breakthrough Device Designation.

This designation is granted to technologies that have the potential to provide more effective treatment, diagnosis or prognosis of life-threatening diseases, such as cancer. The designation enables close collaboration with, and expedited review by the FDA, and provides formal acknowledgement of Oncuria’s utility and potential clinical benefit.  

Oncuria is designed to provide prediction of response to BCG therapy, allowing for timely interventions that could result in more favorable outcomes for our patients”, said Charles J. Rosser, CEO of Nonagen Bioscience. “We are proud that the FDA has decided to grant Breakthrough Device Designation to our lead diagnostic, Oncuria, acknowledging growing recognition of the benefit our test can offer to clinicians and patients.”

Clinical Validation of Oncuria™

Oncuria™ is a urine-based bladder cancer diagnostic.

April 14, 2021

LOS ANGELES, CA—Nonagen Bioscience today announced new data from a study reporting the clinical performance of the multiplex assay (Oncuria). The combination of the 10 biomarkers associated with Oncuria provided an overall sensitivity of 93% and specificity of 93%. Urinary levels of a biomarker panel enabled the accurate discrimination of bladder cancer patients and controls.    

Nonagen Bioscience CEO Charles J. Rosser, MD, MBA said: “The multiplex Oncuria test can achieve the efficient and accurate detection and monitoring of bladder cancer in a non-invasive patient setting.”

Analytical Validation of Oncuria™

Oncuria™ is a urine-based bladder cancer diagnostic.

November 23, 2020

LOS ANGELES, CA—Nonagen Bioscience today announced new data from a study reporting the analytical performance of the multiplex assay (Oncuria™). Analytical evaluation demonstrated a) all antigen cross-reactivity to be < 1% of the tested concentration, b) minimal detected dose ranged from 0.295 pg/mL in IL8 to 31.1 pg/mL in APOE, c) highly reproducible and accurate coefficient of variation (CV) and relative error (RE) values below 15% for all analytes and d) minimal interference. The assay can be completed in <5 hours using as little as 150 microliter of voided urine. 

Nonagen Bioscience CEO Charles J. Rosser, MD, MBA noted: “This is a significant milestone for Nonagen and a major step in bringing a new diagnostic to the market to help clinicians and patients.”

Production of prototype multiplex bead-based immunoassay for detecting a urine-based bladder-cancer-associated diagnostic signature (Oncuria™)

Oncuria™ predicts the presence of bladder cancer in a simple urine sample.

October 30, 2019 

JACKSONVILLE, FL—Nonagen Bioscience today announced new data from a study comparing detecting 10 bladder cancer associated biomarkers using standard ELISA kits to multiplex electrochemoluminescent assay to multiplex bead-based immunoassay. The study noted superior bladder cancer detection rates with the multiplex bead-based immunoassay; sensitivity 93%, specificity 95% and negative predictive value of 93%. The study entitled "Comparison of Commercial ELISA Kits, a Prototype Multiplex Electrochemoluminescent Assay, and a Multiplex Bead-Based Immunoassay for Detecting a Urine-Based Bladder-Cancer-Associated Diagnostic Signature” was published in the October issue of Diagnostics 2019 Oct 29;9(4).

Oncuria measures expression levels of ten biomarkers that are then combined into a single score. The ten biomarkers measured by Oncuria are: APOE, A1AT, ANG, CA9, IL8, MMP9, MMP10, PAI1, SDC1 andVEGF.

Nonagen Bioscience CEO Charles J. Rosser, MD, MBA said: “The production of a robust prototype diagnostic assay with our manufacturing partners Bio Techne has been achieve. Our sights are now set on analytical and clinical validation.”

nonagen receives second patent for its multiplex bladder cancer signature

June 8, 2018

JACKSONVILLE, FL—Nonagen Bioscience today announced that the United States Patent and Trademark Office (PTO) has issued United States Patent No. 9,964,542. The patent provides a second intellectual property protection for Nonagen Bioscience's Oncuria bladder cancer testing. 

Oncuria is a non-invasive multiplex bead-based immunoassay capable of measuring the urinary expression levels of ten biomarkers, APOE, A1AT, ANG, CA9, IL8, MMP9, MMP10, PAI1, SDC1 and VEGF to generate a bladder cancer risk score.

The recently issued patent is co-assigned to Nonagen Bioscience and Drs. Charles J. Rosser and Steve Goodison. Nonagen will continue to pursue additional patent applications, which if issued, should expand the scope of intellectual property protection for Oncuria.
 

Nonagen Bioscience announces results from a meta-analysis study of its bladder cancer detection signature

January 3, 2018

JACKSONVILLE, FL—Nonagen Bioscience today announced that new data from a meta-analysis of clinical studies comprised of more than 1,100 patients showed that a 10-plex urine-based bladder cancer diagnostic signature has the potential to non-invasively predict the presence of bladder cancer in at-risk patients—blood in the urine, hematuria, or a history of bladder cancer on surveillance. The study entitled "Meta-analysis of a 10-plex urine-based biomarker assay for the detection of bladder cancer" was reported in the January 2018 issue of Oncotarget.

Nonagen Bioscience CEO Charles J. Rosser, MD, MBA noted: “Importantly, this analysis confirms the consistency and robustness of our previous findings, substantiate our US and Chinese patents and gives great anticipation to our ongoing Phase III clinical trials in the US. This is a very exciting time for Nonagen.”

State Intellectual Property Office of the People's Republic of China Grants Patent for multiplex bladder cancer signature

December 19, 2017

JACKSONVILLE, FL—Nonagen Bioscience today announced that the State Intellectual Property Office of the People's Republic of China has issued certificate of issue patent No. 201380048105.8. The patent provides intellectual property protection for Nonagen Bioscience's Oncuria bladder cancer testing. 

Oncuria is an advanced urine test for adults with blood in the urine (hematuria) or a history of bladder cancer on surveillance and helps physicians determine risk of patient harboring bladder cancer. Oncuria measures expression levels of ten biomarkers that are then combined into a single score. The ten biomarkers measured by Oncuria are: APOE, A1AT, ANG, CA9, IL8, MMP9, MMP10, PAI1, SDC1 andVEGF.

The recently issued patent is co-assigned to Nonagen Bioscience and Drs. Charles J. Rosser and Steve Goodison and is the first patent issued relating to Oncuria. Nonagen will continue to pursue additional patent applications, which if issued, should expand the scope of intellectual property protection for Oncuria.

United States Patent and Trademark Office Grants Patent for multiplex bladder cancer signature

February 3, 2016

JACKSONVILLE, FL—Nonagen Bioscience today announced that the United States Patent and Trademark Office (PTO) has issued United States Patent No. 9,249,467. The patent, which is expected to expire in 2031, provides intellectual property protection for Nonagen Bioscience's Oncuria™ bladder cancer testing. 

Oncuria™ is an advanced urine test for adults with blood in the urine (hematuria) or a history of bladder cancer on surveillance and helps physicians determine risk of patient harboring bladder cancer. Oncuria™ measures expression levels of ten biomarkers that are then combined into a single score. The ten biomarkers measured by Oncuria™ are: APOE, A1AT, ANG, CA9, IL8, MMP9, MMP10, PAI1, SDC1 andVEGF.

The recently issued patent is co-assigned to Nonagen Bioscience and Drs. Charles J. Rosser and Steve Goodison and is the first patent issued relating to Oncuria™. Nonagen will continue to pursue additional patent applications, which if issued, should expand the scope of intellectual property protection for Oncuria™.