On December 6, 2021 Paige, the global leader in AI-based diagnostic software in pathology, reported it will present new data demonstrating the performance of Paige Breast "Beta" in detecting various forms of breast cancer and highlight the accuracy of a new AI-based system that detects invasive lobular carcinoma (ILC), the most frequent subtype of breast cancer (Press release, Paige AI, DEC 6, 2021, View Source [SID1234596512]). The data will be featured during a Spotlight Poster Discussion at the upcoming 2021 San Antonio Breast Cancer Symposium (SABCS 2021), taking place virtually and in-person at the Henry B. Gonzalez Convention Center in San Antonio, Texas from December 7-10, 2021.

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An artificial intelligence-based predictor of CDH1 biallelic mutations and lobular carcinoma
Authors: Jorge S. Reis-Filho, et al.
Session: Spotlight Poster Discussion 11 – The future is now: Innovation in pathology and radiology
Poster #: PD11-01
Date and Time: Thursday, December 9, 2021; 5:00 p.m. – 6:30 p.m. CST
Location: Stars at Night Ballroom 3&4
Subtyping invasive carcinomas and high-risk lesions for Machine-Learning-Based Breast Pathology
Authors: Matthew G. Hanna, et al.
Session: Spotlight Poster Discussion 11 – The future is now: Innovation in pathology and radiology
Poster #: PD11-02
Date and Time: Thursday, December 9, 2021; 5:00 p.m. – 6:30 p.m. CST
Location: Stars at Night Ballroom 3&4
Additionally, Thomas J. Fuchs, Dr.Sc., Chief Scientist and Founder of Paige, will discuss the implications of AI technology in pathology during an educational session titled "Artificial Intelligence: Beyond the Soundbites," moderated by Jorge S. Reis-Filho, M.D., Ph.D., Principal of Biomarker Development at Paige and Chief of Experimental Pathology Service at Memorial Sloan Kettering Cancer Center. Details are below:

Artificial intelligence: Guiding the pathologists’ eyes
Presenter: Thomas J. Fuchs
Session: Educational Sessions
Date and Time: Tuesday, December 7, 2021; 5:00 p.m. – 7:00 p.m. CST
Location: Stars at Night Ballroom 3&4
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On December 6, 2021 Helio Health ("Helio") and its commercial partner, Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent"), reported the commercial launch of HelioLiver, a multi-analyte blood test that incorporates cell free DNA (cfDNA) methylation patterns and serum protein markers for the detection of hepatocellular carcinoma (HCC) – the most common form of liver cancer (Press release, Fulgent Genetics, DEC 6, 2021, View Source [SID1234596511]). HelioLiver can detect HCC at its earliest stages when lesions are still very small, an area where traditional standard-of-care imaging tools often fall short, with the potential to enable more curative treatment options known to increase five-year survival rates by up to 13 times compared to when cancer has metastasized.1,2

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Recent data presented at The Liver Meeting 2021 outlined HelioLiver’s superior sensitivity over currently available blood-based tests. With a specificity of 91%, HelioLiver demonstrated 76% sensitivity in detecting early-stage HCC, significantly outperforming other detection tools such as AFP (57%), GALAD (65%), and ultrasound (47%).3,4

"We are excited to offer patients at high risk of developing liver cancer a convenient and sensitive serial testing option to catch cancer early when it counts the most," said Justin Chen Li, U.S. Chief Executive Officer, Helio Health. "We are proud to partner with Fulgent to launch this innovative, simple, and reliable test that has the potential to redefine the future of cancer testing and foster better patient outcomes."

HelioLiver offers a simplified process for patients with a blood draw that can be conducted during a routine check-up, providing a quick and accurate way to receive regular surveillance for people at risk of developing liver cancer. While the American Association for the Study of Liver Diseases (AASLD) guidelines recommend ultrasound screening every six months for patients who are at risk, studies have shown that as few as 20% of patients actually receive regular surveillance due to the inconvenience of accessing testing via ultrasound.5 Helio believes this number can dramatically increase with this new, blood-based test.

"Through our partnership with Helio, our joint priority is to bring HelioLiver to providers and patients in a seamless manner," said Brandon Perthuis, Chief Commercial Officer, Fulgent Genetics. "Leveraging our extensive commercial infrastructure, we are well-positioned to deliver an easy ordering experience for providers with our representatives at the ready to provide the best-in-class white glove service throughout the entire experience."

Providers can place orders online at HelioLiver.com/how-to-order, via phone (+1 626-350-0537) or email at [email protected] to get connected with a representative.

For more information about HelioLiver and its clinical performance, please visit www.HelioLiver.com.

On December 6, 2021 Novocure (NASDAQ: NVCR) reported the 4th Annual AACR (Free AACR Whitepaper)-Novocure Grants for Tumor Treating Fields Research Program. The program represents a joint effort with the American Association for Cancer Research (AACR) (Free AACR Whitepaper) to promote and support innovative research on Tumor Treating Fields (TTFields) to help deepen the understanding of the mechanism of action and to accelerate the development of new treatment strategies (Press release, NovoCure, DEC 6, 2021, View Source [SID1234596510]). The program includes research grants and career development awards totaling more than $2 million over the next three years.

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The research grants will include five AACR (Free AACR Whitepaper)-Novocure Tumor Treating Fields Research Grants and two AACR (Free AACR Whitepaper)-Novocure Career Development Awards for Tumor Treating Fields Research. Recipients of the research grants will receive a total of $250,000 over two years. Recipients of the career development awards will receive a total of $225,000 over three years.

"We are thrilled to continue our partnership with Novocure," said Mitch Stoller, the AACR (Free AACR Whitepaper)’s Chief Philanthropic Officer. "These two grant mechanisms represent an important means for advancing the science of TTFields research and attracting talented investigators. We once again look forward to learning about the outstanding projects that will result from these grants and to meeting next year’s class of grantees."

Novocure and the AACR (Free AACR Whitepaper) encourage applicants to focus their proposals on translational approaches, promoting the transition of in vitro work into in vivo systems; combination therapies involving Tumor Treating Fields; and bringing treatments involving Tumor Treating Fields to the clinic. The application deadline is January 20. Recipients will be announced in April at the AACR (Free AACR Whitepaper) Annual Meeting 2022 in New Orleans.

"Deepening our understanding of the mechanism of action of Tumor Treating Fields can potentially advance our efforts to extend survival in some of the most aggressive forms of cancer," said Dr. Uri Weinberg, Novocure’s Chief Science Officer. "We are excited to partner with the AACR (Free AACR Whitepaper) to offer this innovative research program for the fourth year and look forward to the announcement of recipients at the AACR (Free AACR Whitepaper) Annual Meeting."

To apply for the AACR (Free AACR Whitepaper)-Novocure Grants for Tumor Treating Fields Research, visit www.aacr.org/funding.

About Tumor Treating Fields

Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division. Fundamental scientific research on TTFields extends across more than two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. TTFields therapy is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields therapy has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, including four phase 3 pivotal trials in a variety of tumor types. To date, more than 20,000 patients have been treated with TTFields therapy.

On December 6, 2021 GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, reported a partnership with Alignment Health Plan, a national Medicare Advantage health plan from Alignment Healthcare (NASDAQ: ALHC), to provide its Medicare Advantage members access to Galleri, GRAIL’s groundbreaking multi-cancer early detection blood test (Press release, Grail, DEC 6, 2021, View Source [SID1234596509]). Based in Orange, California, Alignment Health Plan is the first Medicare Advantage plan to offer the Galleri test as a complement to recommended single cancer screenings.

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"Providing innovative benefits to support the health and care needs of our members is what we do here at Alignment," said Dawn Maroney, markets president, Alignment Healthcare, and CEO, Alignment Health Plan (CA). "Taking preventive measures before signs and symptoms appear is key to finding cancer early when it is most treatable. We are excited to partner with GRAIL to provide seniors the tools they need to proactively manage their health."

New and existing Alignment Health Plan members who enroll in select HMO and PPO plans in California and North Carolina1 will have access to Galleri beginning Jan. 1, 2022. Galleri is available by prescription only.

"GRAIL is thrilled to partner with Alignment Health Plan to offer our first-of-its-kind Galleri test to a population that by age alone has an elevated risk of developing cancer," said Dr. Josh Ofman, president and chief medical officer at GRAIL. "Providing access to a technology that can detect cancer signals in the blood, even before symptoms appear, can help us decrease the burden of late-stage cancer diagnoses. We commend Alignment for its innovative and proactive approach to early cancer detection for Medicare Advantage members."

In a clinical study, Galleri demonstrated the ability to detect more than 50 types of cancer, over 45 of which lack recommended screening tests today, with a low false positive rate of less than 1%. When cancer is detected, Galleri can determine the cancer signal origin with high accuracy.

More than 600,000 people died from cancer last year in the United States, according to the American Cancer Society. This is in large part because the majority of cancers are found too late when outcomes are often poor. Recommended screening tests save lives, but only cover five cancer types in the U.S.: breast, colon, cervical, prostate, and (in high-risk adults) lung. In fact, about seven in ten cancer deaths have no recommended early detection screening.

On December 06, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a company applying innovative diagnostics to transform disease management and improve patient outcomes, reported it has completed its acquisition of Cernostics, Inc. (Cernostics). Cernostics specializes in spatial biology and artificial intelligence-driven image analysis of tissue biopsies (Press release, Castle Biosciences, DEC 6, 2021, View Source [SID1234596508]). Its TissueCypher Barrett’s Esophagus Assay is the first precision medicine test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s esophagus (BE).

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"We are excited to continue the evolution of the Castle story with the closing of the Cernostics acquisition and our entry into the gastrointestinal space through the TissueCypher platform," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "The TissueCypher Barrett’s Esophagus Assay is designed to help predict the likelihood of BE’s progression to the more serious HGD or highly aggressive esophageal adenocarcinoma (EAC). Annually, approximately 400,000 endoscopies are performed on BE patients who meet the validated intended use population. We believe we have a unique opportunity to help physicians and patients make more informed disease management decisions based on deep interrogation of the biology of an individual patient’s esophageal biopsy."

Transaction Terms and Other Information

Under the terms of the definitive agreement, Cernostics has become a wholly owned subsidiary of Castle Biosciences. At closing, Castle paid approximately $30 million in initial consideration to Cernostics security holders, which consisted entirely of cash. Up to an additional $50 million in cash and/or common stock, at Castle’s sole discretion, is payable in connection with the achievement of certain milestones based on 2022 performance. The purchase price is subject to customary working capital and other adjustments.

TissueCypher Platform and the TissueCypher Barrett’s Esophagus Assay

The TissueCypher platform combines a unique approach designed to bring together the key elements of biologically aware artificial intelligence to deliver the spatialomics revolution to the clinician and enable individualized decision-making. This technology and platform are the core of the TissueCypher Barrett’s Esophagus Assay, the world’s first precision medicine test designed to predict future development of HGD and/or esophageal cancer in patients with BE. The TissueCypher Barrett’s Esophagus Assay is indicated for patients with endoscopic biopsy confirmed BE that is graded non-dysplastic, indefinite for dysplasia or low-grade dysplasia; it has been validated in multiple, independent studies of BE progressor patients. The TissueCypher Barrett’s Esophagus Assay is a proprietary Laboratory Developed Test with its own unique CPT PLA code (0108U) and has been on the Medicare Clinical Laboratory Fee Schedule since January 2021.