Exact Sciences Corp., a leading provider of cancer screening and diagnostic tests, announced the launch of the OncoExTra™ therapy selection test in the United States. OncoExTra is a next-generation sequencing (NGS), comprehensive DNA and RNA based genomic test providing doctors and their patients a complete molecular picture of the patient’s cancer. The test provides reliable and actionable results personalized to each patient.

“The OncoExTra test substantially enhances our ability to characterize and understand solid tumors, giving our patients the best chance at treating their cancer successfully,” said Dr. Stephen Gruber, MD, PhD, MPH, vice president of the City of Hope National Medical Center and Director, Center for Precision Medicine at City of Hope. “With this test, I have a much better picture of my patient’s cancer, allowing me to prescribe the most effective treatment for their specific solid tumor.”

The majority of eligible cancer patients do not receive comprehensive genomic profiling (CGP) to help understand their disease and guide treatment. Personalized medicine, powered by CGP, helps oncologists understand the unique biology of each patient’s tumor and prescribe treatments determined to offer the best outcomes.

“Exact Sciences continues to build its leadership in cancer diagnostics by offering innovative tests addressing clinical needs at every step of patient cancer care,” said Kevin Conroy, chairman and CEO of Exact Sciences. “We are proud to add OncoExTra to our growing portfolio of cancer solutions across the cancer-care continuum, and deliver new levels of tumor-specific information and insights to doctors and patients that guide vital treatment decisions to achieve the best outcomes.”

The OncoExTra test uses NGS to assess the tumor’s RNA and DNA, providing actionable information to inform treatment decisions and uncover variants possibly missed by only evaluating DNA. The OncoExTra test works by profiling the entire exome and the transcriptome across approximately 20,000 genes. The American Society of Clinical Oncology (ASCO) has updated its guidelines to recommend RNA-based fusion testing for patients with no actionable information provided by a standard DNA, multigene panel test. OncoExTra also analyzes all National Comprehensive Cancer Network® (NCCN®) recommended genes for patients with solid tumors and provides expertly curated, intuitive reports. The OncoExTra test uses matched tumor-normal sequencing, which also limits false positives and allows physicians to make clinical decisions based on somatic variants detected. Medicare covers the OncoExTra test and doctors can order the test for all advanced solid tumors. The sales team that helps educate oncologists on Oncotype® tests will also bring OncoExTra to market; most oncologists have ordered Oncotype® tests and they can now order both products from a single Exact Sciences portal, streamlining the management and treatment for both early stage and late-stage patients.

The OncoExTra test includes information on targetable mutations and fusions, immuno-oncology signatures and clinical trial options. Healthcare providers can also order immunohistochemical (IHC) panels and individual stains concurrently, allowing them to receive all actionable tumor information from Exact Sciences.
 

Biological Dynamics, Inc., a company commercializing its exosome-isolation ExoVerita™ platform for early disease surveillance and other applications, announced completion of the analytical and clinical validation of its lab developed test (LDT), ExoVita™ Pancreas in the company’s CLIA certified and CAP accredited laboratory.

Using blood-based exosome samples enriched on the proprietary ExoVerita instrument, the ExoVita Pancreas assay measures specific exosomal protein biomarkers and has been demonstrated to detect Stage 1 and Stage 2 pancreatic ductal adenoma carcinoma (PDAC)1.

With this validation, samples from the ExoLuminate registry trial (NCT05625529), a trial which has already begun actively enrolling patients with high-risk for PDAC to investigate the test’s clinical utility, will be tested by the company. Eligible patients include those with a familial or genetic predisposition, an individual’s clinical symptoms such as pancreatitis or known pancreatic lesions, and newly diagnosed diabetics over the age of 50.

“Our published, high sensitivity ExoVita Pancreas assay for early-stage pancreatic cancer is being further validated with prospective clinical samples from our ExoLuminate registry trial. Further leveraging the unique power of our ExoVerita platform, we plan to address additional cancer indications soon,” said Harmeet Dhani, MD, MSc, Director of Medical Affairs at Biological Dynamics. “Our expertise in isolating information rich exosomes, coupled with the unique clinical validity demonstrations, will significantly improve patient care.”

1 – Hinestrosa, J.P., Kurzrock, R., Lewis, J.M. et al. Early-stage multi-cancer detection using an extracellular vesicle protein-based blood test. Commun Med 2, 29 (2022). https://doi.org/10.1038/s43856-022-00088-6

Disclaimer: Biological Dynamics does not provide diagnostic information. ExoVita Pancreas is a ‘Research Use Only’ (RUO) test produced from Biological Dynamics’ CAP/CLIA certified lab. Any and all clinical decision-making remains with each study patient participant and their physician providers.

RTsafe, the leading provider of quality assurance products and services in stereotactic radiosurgery, announces that Spain’s Fundación Instituto Valenciano de Oncología has conducted its first simulated therapy for brain metastases using PseudoPatient, RTsafe’s patient-specific quality assurance process that comprises an anatomically faithful model of each patient’s head aligned to dosimetric evaluation services. The technology enables medical physicists and clinicians to verify the entire treatment process before the actual patient is subjected to radiotherapy.

Commenting on the announcement, Evangelos Pappas, Founder and Chief Scientific Officer at RTsafe said: “We are delighted that IVO, Spain’s internationally renowned centre of excellence in cancer treatment, has embraced the concept of assuring patient safety and treatment efficiency through human-like simulation of the stereotactic radiosurgery process.”

The simulation was carried out ahead of IVO’s first patient treatment using the new TrueBeam linear accelerator from Varian Medical Systems, a Siemens Healthineers company, that integrates radiotherapy and image-guided radiosurgery on the same platform. The machine was acquired as part of the ongoing efforts by IVO’s Radiation Oncology Service to increase patient safety and treatment quality.

A case study published by medical technology distribution company, Aplicaciones Tecnológicas de la Física, points out that due to the complexity of administering SRS plans, periodic quality control protocols and pre-treatment dose verification procedures based on the actual patient anatomy are advisable and could improve treatment efficiency.

The PseudoPatient treatment verification process begins with the construction of a 3D-printed phantom based on the individual patient’s CT scan, accurately reproducing the bone anatomy. The phantom is then filled with a special polymer gel developed by RTsafe that acts as both a soft tissue equivalent material and a 3D dosimeter. The end-to-end radiosurgery procedure is then performed just as it would be on the real patient. The irradiated phantom is then MRI scanned and changes in gel’s magnetic properties reveal the treated areas. RTsafe then provides a comprehensive quantitative and qualitative report in order to assist the clinical team in either verifying the treatment plan or making adjustments to it.

Conventional patient-specific quality control methods involve dose measurements on a standard-shaped phantom equipped with several detectors with the aim of verifying the treatment plan. However, dose treatment verification based on the actual patient anatomy may be critical in minimising unwanted exposure to radiation. RTsafe’s development of PseudoPatient seeks to solve the limitations presented by generic phantoms thereby achieving more rigorous quality control in stereotactic radiosurgery (SRS) treatments.

Evangelos Pappas added: “Brain metastases can occur in more than 30% of all cancer patients and, while SRS is a good treatment option for many patients, its complexity means that accurate pre-treatment dose verification could make a difference to treatment outcomes should an adjustment to dosage or targeting be indicated by the simulation process. The approach improves the confidence of both medical professionals and patients in this exacting treatment method.”

Orion Health, a global leader in population health software, announced that it has gained leading security credentials for two of its flagship products.

Its world-leading Amadeus unified healthcare platform has earned certification for information security by HITRUST. At the same time, its Communicate software solution has also achieved full accreditation through the DirectTrust™ Accreditation Program for Health Information Service Providers (HISPs).

Grant Anthony, Orion Health’s Chief Information Security Officer says the security of patient and clinician data has always been paramount to Orion Health.

“Handling important data across our people, clinicians and data science platforms comes with great responsibility. This means information security is of the utmost importance to us at Orion Health. These certifications are testaments to our commitment to data security and our world-leading technical infrastructure supporting customers all around the world.”

HITRUST Risk-based, 2-year (r2) Certified status demonstrates that Amadeus, hosted by the secure AWS cloud, has met key regulations and industry-defined requirements and is appropriately managing risk. This achievement places Orion Health in an elite group of organisations worldwide that have earned this certification.

Amadeus is an open platform that scales to accommodate the vast amount of data generated by new models of care, to support the journey from population health management to precision medicine. It provides healthcare professionals with the support they need to make the best possible decisions at the point of care.

By including US federal and state regulations, standards, and frameworks, and incorporating a risk-based approach, the HITRUST Assurance Program helps organisations address security and data protection challenges through a comprehensive and flexible framework of prescriptive and scalable security controls.

“The HITRUST Assurance Program is the most rigorous available, consisting of a multitude of quality assurance checks, both automated and manual,” said Bimal Sheth, Executive Vice President, Standards Development & Assurance Operations, HITRUST.

“The fact that Orion Health’s Amadeus has achieved HITRUST Risk-based, 2-year Certification attests to the high quality of their information risk management and compliance program.”

DirectTrust is a non-profit healthcare industry alliance created to support secure, identity-verified electronic exchanges of protected health information between provider organisations, and between providers and patients, for the purpose of improved coordination of care.

Orion Health’s Communicate software solution provides reliable and protected communication between patients, healthcare providers and organisations across desktop and electronic medical record (EMR) systems. It was audited against a series of technical, physical, and operational criteria and found to be fully in compliance with the Direct Standard™ and the requirements of the DirectTrust Security and Trust framework.

“DirectTrust HISP accreditation certifies that an organisation has established and upheld a superior level of trust for its stakeholders, which is a significant distinction. Kudos to Orion Health’s commitment to maintaining the highest standards in privacy, security and confidentiality,” said DirectTrust President and CEO Scott Stuewe.

Gaining two separate forms of security accreditation for two of its products puts Orion Health in an elite class of organisations that is recognised for prioritising security practices.