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Medical Device Innovation Consortium (MDIC) Partners with PerkinElmer’s Horizon Discovery to Improve Accuracy of Next Generation Sequencing-Based Cancer Diagnostics

On October 19, 2022 The Medical Device Innovation Consortium (MDIC) reported that it has partnered with PerkinElmer’s Horizon Discovery to develop and manufacture somatic reference samples (SRSs) to simplify and support validation of next generation sequencing (NGS)-based cancer diagnostics (Press release, The Medical Device Innovation Consortium, OCT 19, 2022, View Source [SID1234622200]). The SRSs are expected to be commercially available by early 2024, following a rigorous characterization and validation process in collaboration with the National Institute for Standards and Technology (NIST).

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This partnership is part of MDIC’s Somatic Reference Samples (SRS) Initiative, a collaborative effort to improve the accuracy of next generation sequencing-based cancer diagnostics, and create publicly available reference samples and a global genomic data resource library. These tools could be used for diagnostic development, regulatory submissions, reimbursement decisions, and other applications across the total product life cycle of NGS-based diagnostics.

"We look forward to combining Horizon Discovery’s technical capabilities in reference sample development and manufacturing with MDIC’s expertise creating and disseminating new methods and tools to advance safe and effective medical technologies. The Somatic Reference Samples Initiative will benefit patients by bringing more consistency to NGS-based cancer diagnostics development and ultimately support improved diagnoses and more effective treatments," said Andrew Fish, MDIC President and CEO.

"Oncology reference standards are essential to unlocking tomorrow’s discoveries," Alan Fletcher, Senior Vice President, Life Sciences, at PerkinElmer commented. "Horizon Discovery’s reference standards have been critical enablers in research for a variety of diseases, and now we look forward to partnering with MDIC to bring standards to the oncology community."

Horizon Discovery will use clustered regularly interspaced short palindromic repeats (CRISPR) technology to engineer and manufacture ten SRSs, each with a different variant or change in the DNA sequence of a gene that has been clinically associated with a certain type of cancer. Leveraging its rich heritage in CRISPR editing technologies, Horizon Discovery has used this process to develop cell-based reference material for over a decade. Upon project completion, MDIC will collect and disseminate best practices to improve the efficiency and sustainability of reference sample manufacture, validation, and dataset generation in general.

The manufacturing process is expected to be completed by 2023 followed by extensive characterization, data validation, and integration. The fully characterized SRSs are expected to be commercially available through Horizon by early 2024, and the characterization data is planned to be accessible through public databases.

MDIC’s SRS Initiative, which includes the FDA, NIST, NIH, CDC, and the pharmaceutical and diagnostics industries as collaborators, began in 2018 with an analysis of the landscape to identify gaps in available SRSs. MDIC’s SRS Landscape Analysis, published in 2019, was an extensive catalog of cancer variants and existing reference materials. The SRS Initiative team has prioritized ten variants from that list to manufacture in this new phase of the initiative. These ten selected variants represent a range of cancers and types of DNA mutations and vary in the degree of technical difficulty required for manufacture for the pilot project to have broad applicability. The work in the SRS Initiative is funded in part by the Gordon and Betty Moore Foundation (Grant GBMF), the National Philanthropic Trust, Illumina, and Quidel. FDA is a member of the MDIC’s SRS Initiative, but did not participate in discussions involving funding, contracts, or solicitations.

Personalis to Announce Third Quarter 2022 Financial Results

On October 19, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported that it will release its third quarter 2022 financial results on Wednesday, November 2, 2022 (Press release, Personalis, OCT 19, 2022, View Source [SID1234622199]). In conjunction with the release, Personalis will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.

To access the live call via telephone, please register in advance using the link here. Upon registering, each participant will receive an email confirmation with dial-in numbers and a unique personal PIN that can be used to join the call.

The live webinar of the call may be accessed by visiting the Events section of the company’s website at investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

Orionis Biosciences Secures $55 Million Financing to Support Advancement into Clinic

On October 19, 2022 Orionis Biosciences, a life sciences company pioneering innovation of highly selective and tunable therapeutics for cancer and beyond, reported it has completed a $55 million financing round and expanded its team, naming Robert Petit, Ph.D., as Senior Vice President, Early Clinical Development and Bihua Chen to the Orionis Board of Directors (Press release, Orionis Biosciences, OCT 19, 2022, View Source [SID1234622198]).

Founded in 2015, Orionis has since developed its proprietary technology platforms, grown a deep pipeline and cemented a drug discovery deal with Novartis. This latest financing round provides the company with additional capital for R&D expansion, pipeline growth and advancement of its lead cancer immunotherapy programs into clinical trials. Existing and new investors participated in the round, including Cormorant Asset Management, Novartis and a series of high-caliber investment funds.

"We are grateful for the strong support of a world-class investor syndicate that shares our passion for advancing new modalities in cancer and other diseases," said Nikolai Kley, Ph.D., Co-founder, President and Chief Executive Officer at Orionis. "As we near the clinic, we are thrilled to bring on Robert Petit, Ph.D., a pioneer in the development of cancer immunotherapies, as our Head of Early Clinical Development. In addition, we are pleased to welcome industry veteran Bihua Chen to our Board as we enter this next stage of growth. With two distinct precision medicine platforms, which focus on expanding druggability through genome-scale molecular glue discovery and on selectively targeting immune cells with conditionally active cytokines to reactivate the cancer immunity cycle, we are well-positioned to advance a diverse pipeline and translate our innovative approaches into new therapies."

"I have spent my career working to develop new and better cancer therapies, so I’m incredibly excited to have joined to lead the team’s translational and clinical development efforts," said Dr. Petit. "We are moving quickly to advance and expand our pipeline of first-in-class immunotherapies. The extraordinary technology platforms at Orionis have the potential to create a new class of more effective and better-tolerated cancer treatments that could significantly extend the potential of immunotherapy. I look forward to supporting Orionis in its path toward a clinical-stage company."

Dr. Petit brings decades of experience in drug development, including at Bristol Meyers Squibb, where he led U.S. Medical development of the first FDA-approved immune checkpoint therapy. He has deep experience across medical and scientific aspects of pharmaceutical development and has directed programs in discovery, translational development and intellectual property development. Dr. Petit received his Ph.D. from The Ohio State University College of Medicine and a B.S. from Indiana State University.

"With its proprietary platform technologies, Orionis has the opportunity to solve some of the biggest challenges in oncology and beyond," said Ms. Chen. "I am honored to join the Board of Directors at Orionis and to work with such an accomplished team."

Ms. Chen is founder and CEO of Cormorant Asset Management, where she manages investments in public and private biopharmaceutical companies. She previously served as a sub-adviser to a large, multi-strategy hedge fund based in New York. Ms. Chen earned an MBA from The Wharton School of the University of Pennsylvania, an M.S. in molecular biology from the Graduate School of Medical Sciences at Cornell Medical College and a B.S. in genetics and genetic engineering from Fudan University.

Orionis is rapidly advancing a deep pipeline of biologics for the treatment of cancer based on its A-Kine platform, which engineers target-selective, conditionally active cytokines designed to trigger anti-tumor immune responses even in "cold" tumors that lack prevalent immune involvement and are refractory to checkpoint inhibitor therapies. A-Kines aim to avoid the systemic toxicities observed with traditional cytokine therapies.

In addition, Orionis is developing a diverse spectrum of small molecule molecular glues using its Allo-Glue platform, harnessing a first-in-class, genome-scale approach to discovery and rational design of molecular glues in order to reach previously intractable targets. Orionis will present preclinical data from its molecular glue platform in October at the following conference:

Nucleix Receives CAP Accreditation and CLIA Certification for its San Diego Clinical Laboratory

On October 19, 2022 Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported that their San Diego-based clinical laboratory received accreditation by the College of American Pathologists (CAP) (Press release, Nucleix, OCT 19, 2022, View Source [SID1234622197]). This achievement follows the recent certification under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 from the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services. These designations highlight the commitment, work ethic and quality demonstrated by the laboratory team.

"As we ramp up research and laboratory operations to evaluate, develop and commercialize methylation-based assays for early cancer detection, receiving these designations provides validation of our ability to accept and report on clinical samples," said Chris Hibberd, Chief Executive Officer at Nucleix. "We are proud of these achievements as we continually seek opportunities to optimize our efforts and ultimately, build technology solutions that help physicians and their patients diagnose cancer earlier, when treatment is most effective."

The CAP Laboratory Accreditation Program is the gold standard for laboratory excellence. Their program fosters an environment for continuous improvement and patient safety.

CLIA certification confirms that Nucleix’s clinical laboratory meets the federal regulations for clinical diagnostic testing, ensuring high quality and safety for patient testing. As part of the certification process, Nucleix completed analytical and clinical validation evaluating the accuracy and reliability of its EpiCheck early detection test platform.

College of American Pathologists (CAP) Accreditation

As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, CAP serves patients, pathologists and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. The Accreditation Committee of the College of American Pathologists has awarded this prestigious recognition based on results of a rigorous on-site inspection of the laboratory’s records and quality control of procedures, laboratory staff qualifications, equipment, facilities, safety program, record and overall management. CAP Accreditation is an internationally recognized program that awards accreditation to laboratories that meet stringent requirements of quality, accuracy, and consistency.

Clinical Laboratory Improvement Amendments (CLIA) Certification

The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Under provisions of the U.S. Department of Health and Human Services’ CMS, the California Department of Public Health granted the company initial registration for high complexity testing through the CLIA Certification Program and follows California State laboratory licensure.

Biocept to Present at the LD Micro Main Event XV

On October 19, 2022 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported that management will present at the LD Micro Main Event XV on Wednesday, October 26 at 2:30 p.m. Pacific time (5:30 p.m. Eastern time) (Press release, Biocept, OCT 19, 2022, View Source [SID1234622196]). The conference is being held at the Luxe Sunset Boulevard Hotel in Los Angeles.

A webcast of the presentation will be live and archived on the Events and Presentation section of the company website.