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Clinical Study Using Trovagene’s Precision Cancer Monitoring Platform Published in Cancer Discovery

Trovagene, Inc., (NASDAQ: TROV) a developer of cell-free molecular diagnostics, recently announced the publication of clinical study results in a peer-reviewed journal, Cancer Discovery, featuring the Company’s precision cancer monitoring technology and its ability to non-invasively determine oncogene mutation status and monitor response to BRAF inhibitor therapy in patients with histiocytic disease, a malignancy often associated with BRAF mutations. Study investigator Eli L. Diamond, M.D., a neuro-oncologist at Memorial Sloan Kettering Cancer Center, will present the clinical results at the 30th Annual Histiocyte Society Meeting on October 28 in Toronto, Canada.

The blinded prospective study in patients with systemic histiocytic disease, such as Erdheim-Chester Disease (ECD) and Langerhans Cell Histiocytosis (LCH), demonstrates that analysis of circulating cell-free DNA (cfDNA) from urine provides a convenient and reliable method to detect the presence of the BRAF V600E mutation and to monitor mutational load repeatedly for assessment of treatment response. Results showed 100% concordance of BRAF V600E status between urinary cfDNA and tissue biopsies in treatment naive patients. Study authors conclude that cfDNA BRAF V600E mutational analysis in urine provides a convenient and reliable method of detecting mutational status and can serve as a non-invasive biomarker to monitor response to therapy in LCH and ECD. 

“More than 50% of patients diagnosed with ECD or LCH harbor the BRAF V600E mutation and might respond well to BRAF inhibitor therapy,” stated Omar Abdel-Wahab, M.D., a hematologist/oncologist at Memorial Sloan-Kettering and principal study investigator. “This study demonstrates that we can now reliably diagnose patients quickly and non-invasively using a liquid biopsy, and that we also now have the ability to monitor treatment response over time to ensure that the targeted therapy is the right choice for the individual patient.” 

In addition to the very high concordance demonstrated between urinary cell-free DNA and tissue biopsy, the study demonstrated that Trovagene’s assay was able to determine BRAF mutational status in all cases when the analysis of tissue biopsies provided inconclusive results. Longitudinal tracking of the BRAF V600E mutation in urine also correlated to therapeutic response as assessed by radiographic evaluation of disease. 

“Both ECD and LCH are thought to be substantially under-diagnosed, often due to the difficulty in obtaining an accurate histological diagnosis,” stated Carlos Rodriguez-Galindo, M.D., Dana-Farber Cancer Institute, an affiliate of Harvard Medical School, and president of the Histiocyte Society. “This non-invasive test may provide an additional tool to help in the diagnosis of those patients whose tumors harbor the BRAF V600E mutation and to monitor the response to treatment.”

Source: PR Newswire

HCG Announces New Standard-of-care for Cancer Treatment in India

HealthCare Global (HCG) Enterprises Ltd, The Specialists in Cancer Care, creates a new benchmark in cancer care by making genomics-based diagnostics, a ‘standard-of-care’ for cancer treatment in India. These diagnostic tests will support physicians, and their patients with the most accurate and advanced tumor profiling of large number genes for “actionable” mutations. The information about these mutations helps to identify targeted therapies and treatment choices early in the course of cancer care.

Bayer HealthCare to Collaborate with Sysmex Inostics GmbH to Develop Blood-based Companion Diagnostic Tests in Oncology

Bayer HealthCare has entered into a master collaboration agreement with the diagnostic company Sysmex Inostics GmbH for the development of companion diagnostics for targeted cancer therapies. The innovative blood-based companion diagnostic solutions offered by Sysmex Inostics will complement anti-cancer agents developed by Bayer.

bioTheranostics Receives Positive Coverage Decision and In-Network Provider Status from Tufts Health Plan for Its CancerTYPE ID Molecular Test for Metastatic Cancer

bioTheranostics, a leading provider of molecular diagnostic solutions for cancer, has received a positive coverage decision and in-network provider status from Tufts Health Plan for its CancerTYPE ID® molecular cancer classifier. Massachusetts-based Tufts Health Plan is one of the nation’s most highly rated health plans serving more than 1 million members.

CancerTYPE ID is a molecular cancer classifier that predicts tumor type in patients with metastatic cancers—among the most difficult to diagnose and treat cancers. Numerous clinical trials and economic analyses have been completed that reinforce the clinical validity and utility, prognostic performance, and cost-effectiveness of the test.

Richard Ding, president and CEO of bioTheranostics, said, “We are pleased that Tufts Health Plan is following Medicare and recognizing the value of the CancerTYPE ID test in the management of metastatic cancer. With metastatic cancer, achieving diagnostic certainty is critical to optimize site-directed therapies that reduce costs and avoid ineffective therapies for both patients and payors. This announcement is part of our efforts to work with payors across the country to make this important diagnostic test available to clinicians and cancer patients, helping to support personalized medicine with the goal of improving outcomes.”

CancerTYPE ID is becoming a standard tool in metastatic cancer management. More than 400,000 patients present with metastatic cancers in the United States each year. An accurate diagnosis of the site of origin is the first step toward personalized medicine, allowing clinicians managing these patients to treat them most effectively using site-specific therapy.

Source: Business Wire

bioTheranostics is Now an In-Network Provider with Highmark Health Services for Its CancerTYPE ID Molecular Test for Metastatic Cancer

bioTheranostics, a leading provider of molecular diagnostic solutions for cancer, is now an in-network provider with Highmark Health Services, and the company’s CancerTYPE ID® molecular cancer classification test may be eligible for Highmark members based on the member’s individual benefits. Pittsburgh-based Highmark is one of the largest health insurers in the United States and the fourth-largest Blue Cross and Blue Shield-affiliated company, operating health plans that serve 5.3 million members.

CancerTYPE ID, an industry-leading molecular cancer classifier based on the expression of 92 genes, predicts tumor type in patients with metastatic cancers—among the most difficult to diagnose and treat cancers.

Richard Ding, president and CEO of bioTheranostics, said, “We are delighted that Highmark is recognizing the value of the CancerTYPE ID test, which is becoming a standard tool of metastatic cancer management. We have built a strong foundation of evidence supporting CancerTYPE ID—from clinical validity to clinical utility and health outcomes. We are working diligently with the payor community to make this high-value diagnostic test available to patients with metastatic cancer and the clinicians caring for them.”

Ding said that in managing metastatic cancer, achieving diagnostic certainty is critical to optimize site-directed therapies that reduce costs and avoid ineffective therapies for both payors and patients. More than 400,000 patients present with metastatic cancers in the United States each year. An accurate diagnosis is the first step toward personalized medicine, allowing clinicians managing these patients to treat them most effectively using site-specific therapy.

Source: BusinessWire