Olaris, Inc., a precision medicine company leveraging metabolomics and machine learning for the discovery and development of its myOLARIS™ diagnostics products, announced that the American Medical Association (AMA) granted a unique PLA (proprietary laboratory analysis) code (0542U) for their myOLARISÔ-KTdx test, a non-invasive assessment of a unique metabolite panel from a urine-based specimen to assess immune status throughout post kidney transplant care. The code will be effective on April 1, 2025. The code is the first ever common procedural terminology (CPT) code that utilizes a metabolomic NUS (non-uniform sampling) HSQC (heteronuclear single quantum coherence) NMR-based algorithm analysis.

“We are committed to developing tools to revolutionize the entire transplant journey”, said Dr. Elizabeth O'Day, CEO and Founder of Olaris. “We are proud of achieving this milestone in the launch of our immune status monitoring test, which demonstrates the clinical application of metabolomics and paves the way for future NMR-based diagnostic applications.”

Accurate post-transplant monitoring of immune status remains a clinical challenge. Current biomarkers are either lagging indicators of injury or have been developed as rule-out assays focused on active rejection with limited clinical value as a rule-in assay for rejection, borderline rejection, subclinical rejection or broader types of graft injury such as polyomavirus associated nephropathy (PVAN). The myOLARIS-KTdx algorithm utilizes a urine-based metabolite signature and clinical data to detect and differentiate a stable graft from graft injury including borderline rejection, subclinical rejection and active rejection due to under-immunosuppression and PVAN due to over-immunosuppression.

“This test has great potential to add to value-based care in the post-transplant period”, said Dr. Ravinder Wali, Professor of Medicine, University of Massachusetts Chan School of Medicine and UMass Memorial Health Care, “Kidney biopsies are invasive procedures that we would like to avoid if possible. From a urine sample, myOLARIS-KTdx provides precise information that helps optimize individual patient immunosuppressant medications mitigating the risk of kidney graft injury due to either under-immunosuppression or over-immunosuppression.”

“Finding a balance in the level of immunosuppression is key to better outcomes for kidney transplant recipients and lengthening the life of the transplanted kidney. There is a huge need for an assay like myOLARIS-KTdx to distinguish stable graft, under-immunosuppression or over-immunosuppression. It also has the potential added value of showing immunosuppression compliance.” said Dr. Anil Chandraker, Professor and Chief of Renal Medicine University of Massachusetts Chan School of Medicine and UMass Memorial Health Care.

Olaris, Inc., a precision medicine company leveraging metabolomics and machine learning for the discovery and development of its myOLARIS™ diagnostics products, announced that Dr. Ernst Schaefer, a 30-year veteran in clinical diagnostics and an expert in developing monitoring tools to improve human health will be joining as CLIA Laboratory Director. Dr. Schaefer will continue in his role as laboratory director for Boston Heart Diagnostics, a company he co-founded in 2007, and at Clinical Enterprise, both in Framingham, MA.

Dr. Schaefer is an internationally recognized leader in the diagnostic world. He is the author of over 600 publications and has overseen the discovery, development, and commercialization of diagnostic products utilizing various biofluids, numerous analytical platforms and across different disease states, with a special focus on cardiovascular disease prevention. Dr. Schaefer has served as a distinguished professor at the Tufts University School of Medicine and the Friedman School of Nutrition Science and Policy at Tufts University, as well as laboratory director and senior scientist at the Human Nutrition Research Center on Aging at Tufts University, in Boston, MA.

"Ernie has one of the top clinical diagnostic minds in the world" said Dr. Elizabeth O'Day, CEO and Founder of Olaris. "He has a strong reputation for consistently going above and beyond to bring novel technologies forward that can improve care. I can't think of a better partner to bring Olaris' innovative diagnostics to the patients that need them".

Dr. Schaefer has been recognized numerous times for his excellence in research and commitment to patient care. He received the JD Lane Award of the U.S. Public Health Service and the National Institutes of Health, the Irvine H. Page Arteriosclerosis Research and Lyman Duff Awards from the American Heart Association, the Saul Horowitz Research and Merker Awards from Mt. Sinai School of Medicine, Oliver Smith Patient Care Awards from Tufts Medical Center, the E.V. McCollum Research Award of the American Society for Clinical Nutrition, a Distinguished Faculty Award from Tufts University, and an honorary doctorate from the University of Buenos Aires, Argentina.

"I'm honored to be joining this world-class team. I couldn't be more excited to support Liz and the team as Olaris reaches this new milestone opening a CLIA lab to provide tests that transform care, first in transplant but with a growing pipeline in broader patient populations." Dr. Schaefer commented.

Olaris, Inc., a precision medicine company leveraging metabolomics and machine learning to discover and develop its myOLARIS™ diagnostics products, is pleased to announce that the company’s research on developing a triple-quadrupole (QqQ) mass spectrometry (MS) platform for clinical metabolomics applications has been selected for a poster presentation on June 5th at the upcoming American Society for Mass Spectrometry (ASMS) 2023 Annual Meeting, to be held June 4th-8th in Houston, TX.

“The new QqQ technology will expand our ability to detect clinically impactful changes in metabolites. Coupled with our CEREBRO machine learning platform, Olaris offers an end-to-end solution for biomarker discovery for internal discovery efforts and as an offering to our strategic partners.” said Dr. Elizabeth O’Day, CEO and Founder of Olaris.

Olaris, Inc., a precision medicine company leveraging metabolomics and machine learning to discover and develop its myOLARIS™ diagnostics products, is pleased to announce that the company’s study on the metabolic changes occurring in donor hearts after Donation after Circulatory Death (DCD) heart transplant has been selected for a poster presentation on June 5th at the upcoming American Transplant Congress (ATC) 2023 Annual Meeting, to be held June 3rd-7th in San Diego, CA.

The ATC 2023 presentation will describe data from a multi-year collaboration between Olaris and an elite team of heart transplant surgeons and researchers at Massachusetts General Hospital, including Drs. Seyed Alireza Rabi, and Asishana Osho. The collaboration was formed with the goal of identifying biomarkers of heart damage due to ischemia and reperfusion during DCD heart transplant. DCD followed by ex vivo machine perfusion, in which organs are procured following circulatory death and placed on a machine to maintain viable status before transplant, represents a new method in heart transplant. Currently, over 3,000 Americans on the heart transplant waiting list each year are unable to access life-saving transplants due to a shortage in donor organs; using DCD for heart transplant has the potential to increase the number of available organs by over 30%, but improved measurements of heart quality are needed to improve DCD outcomes.

Olaris, Inc., a precision medicine company leveraging metabolomics and machine learning for the discovery and development of its myOLARIS™ diagnostics products is pleased to announce the appointment of Dr. Stuart Chaffee, a 20-year veteran in the biopharmaceutical industry, as Executive Chairman.

Dr. Chaffee brings a wealth of experience including contributing to starting four publicly traded biotechnology companies, raising over $900M in private and public capital, and $4.9B in transactions. In this new role for Olaris, Dr. Chaffee will partner with CEO Dr. Elizabeth O’Day and the Board of Directors to develop and execute strategic growth opportunities for the company.

Olaris, Inc., a precision medicine company leveraging metabolomics and machine learning for the discovery and development of its myOLARIS™ diagnostics products, which aim to optimize treatments and outcomes for individual patients, is pleased to announce that the company’s study on the application of the myOLARIS-KTdx kidney transplant graft status score to transplant recipients has been selected for a poster presentation on June 6th  at the upcoming American Transplant Congress (ATC) 2022 Annual Meeting, to be held June 4th-8th in Boston, Massachusetts. To view the poster presentation on video, visit https://youtu.be/QNJmbLaQ5Xc

Olaris, Inc is pleased to announce that the company’s study on the identification of a urine metabolic signature to detect over-immunosuppression in kidney transplant recipients has been selected for a presentation at the International Transplant Science (ITS) 2022 Annual Meeting, to be held May 15th-19th in Berlin, Germany. The presentation will describe the results of a multi-year collaboration between Olaris and Dr. Dirk Kuypers, Professor of Medicine and Chair of the Laboratory of Nephrology at the University of Leuven, to identify a biomarker for over-immunosuppression in kidney transplant recipients.

Olaris, Inc.  is pleased to announce that the company’s presentation on the identification of metabolic reprograming associated with CDK4/6 sensitivity and resistance has been selected for a poster presentation at the upcoming 2022 American Association for Cancer Research (AACR) annual meeting, to be held April 8th - 13th.

The presentation, led by Olaris Metabolite Scientist Dr. Chandrashekhar Honrao, will describe the recent results of a collaboration between Olaris and the Dana Farber Cancer Institute. Using a human breast cancer cell line model and isotope tracers, researchers determined that glucose metabolism was altered following treatment with two CDK4/6 inhibitors, palbociclib and abemaciclib. They also found that cells resistant to the drugs had alterations in different metabolic pathways, representing the first-ever evidence of metabolite signatures specific to two different CDK4/6 inhibitors.

View the presentation at https://youtu.be/nXBiGRcnqXk.

Olaris, Inc. announced today that it has expanded its leadership team with key senior hires who will advance partnerships for and commercialization of its novel diagnostics with the potential to transform how diseases are diagnosed and treated.

Olaris' new additions include:

Russell Herndon as Chief Business Officer. Herndon has more than 30 years' experience leading innovative healthcare technology companies and initiatives.

Laura T. Housman as Chief Commercial Officer. Before joining Olaris, Housman spent more than 30 years driving access to innovation in healthcare focusing on diagnostics, therapeutics, and devices across a range of disease areas.

Olaris, Inc. announced today the appointment of Shawn Ayube, a 20-year veteran in the biopharmaceutical industry, as Vice President of Operations.

In his new role, Ayube will be in charge of driving scalability across the organization and lead the effort to strategically enhance Olaris’ R&D capabilities as well as steering talent management and leadership development.

Olaris Founder and CEO Dr. Elizabeth O'Day will present virtually at the Truist Securities AI Symposium – Biotech & Tools. The symposium will take place virtually on Tuesday, March 1, 2022.

The presentation by Dr. O'Day will discuss the unique combination of metabolomics and machine learning used by Olaris to develop diagnostics to empower patients that they have the right diagnosis and are on the right treatment path.

In addition to speakers, the symposium also features 3 panels, with focuses on applying AI to synthetic biology and therapeutics, utilizing deep learning and quantum physics for drug development, and integrated platforms for AI-based drug discovery. The keynote address will feature a discussion by Pfizer covering the use of AI and pharma in development of the COVID vaccine. A full agenda for the event can be found at: https://www.openexc.com/wp-content/uploads/2022/02/AI-Symposium-Agenda-2.24.pdf .

You can access the presentation on the day of the conference by going to: https://bit.ly/OlarisTruist2

Olaris and Thermo Fisher Scientific are partnering to evaluate the feasibility of a machine learning and metabolomics–based diagnostic panel to assess risk of developing complications from overimmunosuppression in kidney transplant recipients

Olaris presented new data on the identification of metabolic signatures in matched plasma and serum samples associated with tumor proliferation in early-stage breast cancer (eBC) patients treated with Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) at the upcoming San Antonio Breast Cancer Symposium® to be held December 7-10, 2021. The presentation, conducted in collaboration with Dr. Cynthia Ma, Professor of Medicine, Division of Oncology at Washington University in St. Louis, highlights the use of Olaris’ BoR platform to identify metabolic signatures associated with tumor proliferation, an indicator of treatment resistance, in eBC patients treated with CDK4/6i.

Dr. Kuypers is Professor of Medicine and Chair of the Laboratory of Nephrology at the University of Leuven, Belgium. He is also the Head of the Department of Nephrology and Director of the Renal Transplantation Program at the University Hospitals Leuven, Belgium. Dr. Kuypers’ clinical and translational research has spanned renal allograft surveillance using protocol biopsies and biomarkers of allograft status to pre-clinical and clinical immunosuppressive therapy development. He founded the Leuven Renal Allograft Biobank, which contributes prospectively collected biological samples and clinical data to translational studies in kidney transplantation. 

In his role, Dr. Rodrigues will lead the acceleration of Olaris’ data strategy for the continued development of novel diagnostics with the potential to transform how diseases are diagnosed and treated. He will also provide critical insight enabling Olaris to streamline its technology for companion diagnostic development with biopharma partners in clinical trials.

Olaris is pleased to announce the company’s presentation on the identification of metabolic signatures in plasma samples associated with therapeutic response in metastatic gastrointestinal stromal tumors (GIST) has been selected for poster presentation at the upcoming 2021 American Association for Cancer Research (AACR) annual meeting, to be held virtually April 10th - 15th.

The presentation, led by Olaris Metabolite Scientist Dr. Chandrashekhar Honrao, highlights the use of Olaris’ BoR platform to identify metabolic signatures correlated with overall survival and to predict response or resistance to treatment in patients with advanced GIST.

As the newest member of of the technology leader's global program aimed at helping startups scale, Olaris will be steamlining BoR development in immune response, neurodegeneration, and oncology. Olaris will also expand collaboration opportunities within biotechnology and healthcare through Microsoft's global partnership ecosystem.

Olaris has appointed Dr. Cynthia Ma of Washington University in St. Louis and Dr. Massimo Cristofanilli from Northwestern Medicine to its Scientific Advisory Board and Medical Advisory Board. Dr. Ma and Dr. Cristofanilli will provide guidance on commercializing Olaris’ successful research identifying metabolic signatures for response to CDK4/6 inhibitors and building a pipeline of clinically differentiated, high-value diagnostic solutions.

Dr. Elizabeth O’Day will lead personalized medicine investment and adoption efforts globally during three-year term  

Olaris CEO Dr. Elizabeth O’Day will speak at Xcelerating Life Sciences Boston, an Xconomy virtual conference & networking event focused on biopharma’s future in digital health. Dr. O'Day will sit on the panel, “Managing the Patient in the World of Personalized Medicine.”

Olaris’ metabolite profiling platform and machine learning algorithms have the potential to accurately indicate whether HER2-positive metastatic breast cancer patients will respond to trastuzumab therapy.

Initial project focus on uncovering metabolic signatures associated with neurodegenerative disease to provide deeper insight into mechanisms involved in Parkinson’s and its progression.