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OPKO Health's BioReference Laboratories Launches Best-in-Class Next-Generation Sequencing (NGS) Assay

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BioReference Laboratories, an OPKO Health company (NASDAQ:OPK), launched OnkoSight AdvancedTM, a next-generation sequencing (NGS) assay for detailed DNA mutational profiling of tumors. This assay aligns with National Comprehensive Cancer Network (NCCN) and World Health Organization (WHO) guidelines, aiding insights into common cancers. It features key biomarkers like Tumor Mutation Burden (TMB) and Microsatellite Instability (MSI) for advanced malignancies. The launch emphasizes patient-centric care through improved accuracy and faster turnaround, enhancing oncology management.

Positive
  • Launch of OnkoSight Advanced NGS assay enhances diagnostic capabilities in oncology.
  • The assay aligns with NCCN and WHO guidelines, ensuring clinical relevance.
  • Inclusion of key biomarkers (TMB, MSI) supports advanced cancer treatment strategies.
  • Focus on patient-centric care with improved turnaround time and accuracy.
Negative
  • None.

ELMWOOD PARK, N.J., Sept. 1, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ:OPK), along with its specialty oncology division, GenPath, today announced the launch of OnkoSight AdvancedTM, a next-generation sequencing (NGS) assay that enables revolutionary deoxyribonucleic acid (DNA) mutational profiling of tumor samples.

OnkoSight Advanced NGS testing provides targeted gene content that is aligned with the latest National Comprehensive Cancer Network (NCCN) and World Health Organization (WHO) guideline recommendations, to provide critical insights into many of the most common cancer types. Additionally, OnkoSight Advanced panels each include key biomarkers: Tumor Mutation Burden (TMB) and Tumor-Only Microsatellite (MSI), which are critical when profiling advanced stage tumor malignancies to guide potential immunotherapy.

"OnkoSight Advanced NGS panels are tumor-type specific and optimized to exclude extraneous gene content, significantly improving clinical actionability and relevance of the data to effectively guide real-world oncology patient management," said Bevan Tandon, M.D., Hematopathologist and Molecular Pathologist, Director of Cancer Genomics at BioReference Laboratories. "Coupled with BioReference and GenPath's comprehensive oncology test menu, OnkoSight Advanced empowers physicians to make informed decisions effectively and efficiently."

"A cancer diagnosis and treatment path are difficult to address with patients and their families, which drives the importance of understanding a patient's risk group and accurately diagnosing the type of cancer, to result in a targeted treatment strategy and prognosis assessment," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "The latest advancement from BioReference's oncology division underscores the commitment to patient-centric care through our industry-leading result turnaround time with enhanced accuracy."

For more information about OnkoSight Advanced, visit: https://www.genpathdiagnostics.com/hcp/onkosight-advanced-tm-next-generation-sequencing/.

About BioReference Laboratories, Inc.
BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups.  BioReference has been working expeditiously to develop and offer test services that will yield high quality and accurate results, including a molecular test for helping with COVID-19 diagnosis and a serology test to help indicate possible COVID-19 exposure. The company is in network with the five largest health plans in the United States, operates a network of 11 laboratory locations, and is backed by a medical staff of more than 120 M.D., Ph.D. and other professional level clinicians and scientists.  With a leading position in the areas of genetics, women's health, maternal fetal medicine, oncology and urology, BioReference and its specialty laboratories, GenPath and GeneDx, are advancing the course of modern medicine.  For more information, visit www.bioreference.com.

About OPKO Health, Inc.
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding our NGS assay, whether it will prove to be best-in-class or revolutionary, whether the test will perform or be as accurate as anticipated,  the role and value of the information provided and its impact on decisions to be made by physicians, and statements about our result turnaround time and accuracy, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

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SOURCE BioReference Laboratories, Inc.

FAQ

What is OnkoSight Advanced by OPKO Health?

OnkoSight Advanced is a next-generation sequencing assay launched by BioReference Laboratories, designed for DNA mutational profiling of tumors.

How does OnkoSight Advanced improve oncology patient care?

It provides targeted gene content and includes key biomarkers to guide treatment decisions for advanced malignancies.

What are the key features of the OnkoSight Advanced NGS assay?

The assay includes alignment with NCCN and WHO guidelines, and features biomarkers like Tumor Mutation Burden (TMB) and Microsatellite Instability (MSI).

When was OnkoSight Advanced launched?

OnkoSight Advanced was launched on September 1, 2020.

What is the significance of the TMB and MSI biomarkers in cancer treatment?

TMB and MSI biomarkers are crucial for profiling advanced tumor malignancies and guiding immunotherapy.

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