On May 2, 2021 Sengenics, the Functional Proteomics Company, reported the commercial launch of the Sengenics AxCESS research services suite which features three new KREX-based functional protein arrays developed for higher throughput and cost-effective immuno-proteomics applications (Press release, Sengenics, MAR 2, 2021, View Source [SID1234575969]). This range of arrays aims to provide greater access to Sengenics’ KREX technology to further facilitate autoantibody characterisation with a focus on autoimmune and cancer research.

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"The presence of autoantibodies years before disease onset makes them important potential biomarkers for early diagnosis and better prognosis. However, the field of autoantibody-based immuno-proteomics has been under researched to date and has been restricted by the availability of technologies that have the reproducibility, dynamic range, low limit of detection and low false positive rates required for autoantibody biomarker discovery. With KREX, higher sensitivity and accuracy is achieved due to the production of full-length, correctly folded proteins and our unique surface chemistry. I am delighted that we are now able to make this technology more widely accessible and affordable to researchers who are working towards making impactful contributions in this field," said Professor Jonathan Blackburn, CSO of Sengenics.

In the last 12 months, Sengenics has made significant discoveries of highly accurate autoantibody biomarker signatures for early diagnosis of Melanoma, Systemic Lupus Erythematosus and illness severity in COVID-19. In addition, the company has filed landmark patents for response prediction in one of the world’s best-selling autoimmune drugs and early diagnosis of Non-small Cell Lung Cancer. Sengenics has also developed the OncoREX p53 cancer array in collaboration with Professor Sir David Lane. Containing over 100 clinically relevant mutant p53 variants, OncoREX can be used for drug discovery as well as autoantibody and antibody screening in cancers.

In conjunction with the launch of AxCESS, Sengenics has made significant investments in scaling up production and operations to provide faster turnaround times and enhanced service offerings.

On March 2, 2021 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, when it can be cured, reported a partnership with leading health system Providence to advance the science and delivery of cancer care (Press release, Grail, MAR 2, 2021, View Source [SID1234575968]). Providence, based in Renton, Washington, will be the first health system to offer Galleri, GRAIL’s multi-cancer early detection blood test, as a complement to recommended single cancer screening tests.

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The Galleri test initially will be used by Providence at its California, Washington, and Oregon points of care, and could eventually be available across Providence’s entire seven-state footprint that includes more than 50 hospitals and nearly 1,100 health clinics serving 5 million patients. Providence aims to pursue effective ways to identify cancer earlier in patient lives, and will integrate the Galleri test into clinical care to help drive earlier detection of multiple cancers and to try to improve and save lives.

"Today, the majority of cancers are found too late when outcomes are often fatal, and as a result, cancer is projected to become the leading cause of death worldwide," said Hans Bishop, chief executive officer at GRAIL. "Providence is a leading health system that shares our commitment to improving and saving lives, and our partnership moves us that much closer to making a tremendous and potentially life-altering difference for patients and providers. We are encouraged by interest in Galleri from health systems, medical practices, and self-insured employers, and excited by the progress in our mission to detect cancer early."

"At Providence, we continuously strive to deliver the most innovative medical advances to our patients, and we are thrilled to partner with GRAIL on implementation research that may bring Galleri to all the communities we serve," said Amy Compton-Phillips, MD, chief clinical officer at Providence. "When combined with the power of our genomics research, having a single blood test that can detect more than 50 cancers advances our goal of finding cancer early, enabling our providers to administer treatment when it’s most likely to be successful and giving our patients the opportunity to achieve the best possible outcomes."

GRAIL previously announced it expects to introduce Galleri in the second quarter of 2021. The blood test, which will be prescription only, will be available initially through partner health systems, medical practices, and self-insured employers.

An earlier version of Galleri demonstrated the ability to detect more than 50 types of cancers — over 45 of which lack recommended screening tests today — with a low false positive rate of less than 1%. When a cancer signal is detected, Galleri can determine where in the body the cancer is located with high accuracy, all from a single blood draw.

On March 2, 2021 Guardant Health, Inc. (Nasdaq: GH) reported that it has CE-marked Guardant360 CDx for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm (cancerous tumor) (Press release, Guardant Health, MAR 2, 2021, View Source [SID1234575967]). The test is also approved as a companion diagnostic to identify non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with Tagrisso (osimertinib).

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The Guardant360 CDx test offers patients and clinicians a simple, faster blood test to help inform personalized treatment options. The Guardant360 CDx received U.S. FDA approval in August 2020.

"Gaining the CE-mark for our Guardant360 CDx test is an important step to making our test more widely accessible to patients around the world. We are committed to helping cancer patients be comprehensively tested to see if they are appropriate for potentially life-changing personalized treatments," said Helmy Eltoukhy, Guardant Health CEO.

The World Health Organization estimates over 10 million cancer deaths in 2020,1 many of whom may have benefitted from CGP to guide a more personalized treatment plan based on a growing list of effective CGP-informed targeted therapies. Clinical studies show that patients receiving targeted therapies have improved progression-free survival and higher overall response rates relative to chemotherapy or immunotherapy.2-8 Clinical adoption of targeted therapies lags behind medical guidelines due to several factors, including insufficient tissue for biopsy, which is the case for as many as 30 percent of solid cancer patients.9-11

Since the company’s inception, Guardant Health has been dedicated to unlocking the potential of liquid biopsy to transform cancer by enabling precision oncology at all stages of the disease. The FDA approval and CE-marking of Guardant360 CDx for tumor mutation profiling and as a companion diagnostic for Tagrisso (osimertinib) represents a critical milestone in the company’s mission to conquer cancer with data. The Guardant360 CDx is also being developed as a companion diagnostic for investigational products in development by other collaborators, including Amgen, Janssen Biotech, Inc., and Radius Health, Inc.

On March 2, 2021 Agilent Technologies Inc. (NYSE: A), reported it has entered into a definitive agreement to acquire Resolution Bioscience Inc., a leader in the development and commercialization of next-generation sequencing (NGS)-based precision oncology solutions (Press release, Agilent, MAR 2, 2021, View Source [SID1234575966]). The acquisition complements and expands Agilent’s capabilities in NGS-based cancer diagnostics and provides the company with innovative technology to further serve the needs of the fast-growing precision medicine market. Under the terms of the agreement, Agilent will pay $550 million in cash at closing and up to an additional $145 million based on achieving future performance milestones.

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Resolution Bioscience’s noninvasive liquid biopsy assay platform supports both the biopharma services market and the clinical oncology diagnostic testing market and is enabled by its Clinical Laboratory Improvement Amendments (CLIA)-certified lab. The platform has been designed for both a centralized CLIA test service and a distributable kit format. In addition, the Resolution Bioscience homologous recombination deficiency (HRD) assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration. The assay is performed on a standard blood sample and detects actionable mutations in genes for identifying cancer. Last year, Resolution Bioscience announced a commercial partnership with LabCorp to enable broad access to the Resolution ctDx Lung test that detects actionable mutations in genes associated with non-small cell lung cancer.

"We are extremely pleased to add Resolution Bioscience’s outstanding team and powerful technology to Agilent’s growing business in precision oncology solutions," said Mike McMullen, Agilent president and CEO. "By adding Resolution Bioscience’s liquid biopsy-based diagnostic technologies to our portfolio, we are strengthening Agilent’s offering to our biopharma customers and boosting the growth of our diagnostics and genomics business. This also accelerates our strategy to broaden access to precision oncology testing for patients worldwide through distributed NGS-based diagnostic kits. We look forward to Resolution Bioscience joining with us to expand our work in the fight against cancer."

"Agilent’s broad expertise, global regulatory and commercial infrastructure, extensive partnerships with biopharma companies, and decades-long leadership in precision medicine will enhance and accelerate our groundbreaking work," said Mark Li, Resolution Bioscience president and CEO. "We are excited to further expand the use of NGS in precision oncology for clinical diagnostics as part of the Agilent team."

Resolution Bioscience is based in Kirkland, Washington. The company had revenues of approximately $35 million in calendar year 2020 and is expected to generate $50 million to $55 million in revenue this year. The acquisition is expected to be slightly dilutive to Agilent’s non-GAAP earnings per share in fiscal 2021 and 2022, and improving in the following years.

The transaction is expected to close in April, subject to regulatory approvals and customary closing conditions.

On March 1, 2021 Akoya Biosciences, Inc., The Spatial Biology Company, reported a collaboration with the Bloomberg-Kimmel Institute for Cancer Immunotherapy (BKI) and the Bloomberg Center for Physics and Astronomy at the Johns Hopkins University School of Medicine (Press release, Akoya Biosciences, MAR 2, 2021, View Source [SID1234575965]). The agreement brings together Akoya’s Phenoptics multiplex immunofluorescence (mIF) platform for spatial phenotyping and Johns Hopkins’ AstroPath platform, an interdisciplinary team of immunologists, pathologists, oncologists, and astrophysicists focused on immuno-oncology biomarker discovery and validation. As part of the collaboration, researchers will develop, validate, and clinically implement novel spatial phenotypic signatures for immunotherapy and facilitate more effective drug development using Phenoptics technology.

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Immunotherapies utilize the immune system to combat cancer and are revolutionizing the field of oncology. Despite this great progress, most patients do not respond to immunotherapy, creating a pressing need for clinically validated biomarkers that accurately predict which patients are likely to benefit from a particular treatment.

A recent multi-institutional study found that mIF, which preserves the spatial context of cellular expression and whole tissue architecture, more precisely predicts response to immunotherapy compared to gene expression profiling, tumor mutational burden (TMB), and current single-marker immunohistochemistry1. The Phenoptics mIF platform provides an end-to-end solution with the reproducibility, sensitivity, and throughput needed to overcome the biomarker challenge by turning spatial data into actionable intelligence.

The AstroPath program applies an innovative approach to analyze large mIF datasets by using celestial object–mapping algorithms to rapidly identify optimized predictive signatures. The program leverages the principles of immunology, pathology, computer science, and astronomy to lay the foundation for rapid, efficient biomarker discovery. The real power of the AstroPath platform comes from the unique combination of knowledge and skills of the principals involved – Dr. Janis Taube, Director of the Division of Dermatopathology, Dr. Drew Pardoll, Director of the Bloomberg~Kimmel Institute for Cancer Immunotherapy, and Dr. Alex Szalay, Bloomberg Distinguished Professor in the Department of Computer Science, an avid astrophysicist and big data expert.

This collaboration lays out an integrated process for biomarker development from discovery to eventual clinical use. Johns Hopkins will receive support to further develop its AstroPath biomarker platform and Akoya will work with AstroPath and its partners to convert AstroPath discoveries to standardized high-throughput assays for clinical and translational studies. Together, the teams will help immuno-oncology groups within pharmaceutical and biotech companies take full advantage of biological information made available by multiplexed immunofluorescence, to accelerate development of new immunotherapies and commercialize predictive tests that can identify upfront those patients likely to respond to specific immunotherapies.

Cliff Hoyt, Vice President of Translational and Scientific Affairs at Akoya, commented, "We have worked closely with the Johns Hopkins team as they have refined multiplexed immunofluorescence methods and integrated them into their AstroPath platform. This paves the way for us to rapidly explore the deep spatial biology of whole tissue sections. Now, we look forward to making this method available to researchers developing new immunotherapies and to enable better stratification of patients once new biomarkers become validated and standardized."

"Through the AstroPath collaboration, we have a unique opportunity to push the limits of our Phenoptics platform in the realm of spatial tissue exploration, and broadly disseminate the discoveries and inventions from a world-leading interdisciplinary team of experts at Johns Hopkins," said Brian McKelligon, Chief Executive Officer of Akoya. "The results of this collaboration could help reshape the future of immunotherapy biomarker development."

The latest findings from the AstroPath platform can be viewed in this virtual Science/AAAS presentation by Dr. Janis Taube and Dr. Alex Szalay.