On October 28, 2021 NeuroLogica Corp. reported it has received Food and Drug Administration (FDA) 510(k) clearance for its Auto Lung Nodule Detection (ALND) tool (Press release, Samsung BioLogics, OCT 28, 2021, View Source [SID1234592141]). The offering provides an on-device, computer-assisted detection (CADe) solution for detecting pulmonary nodules from 10 to 30mm in size through an artificial intelligence (AI) algorithm.*

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It is designed to aid the physician in reviewing PA chest radiographs of adults and is part of S-Station, an operation software installed on Samsung Digital X-ray Imaging systems.

"This FDA clearance is a huge milestone for Samsung and is the result of our tireless work to design diagnostic solutions that empower providers to deliver patients the absolute best care possible," said David Legg, Vice President of Digital Radiography and Ultrasound at Samsung NeuroLogica. "The fact that it delivers clinically reliable results means clinicians can present it to patients with the utmost confidence, and for that we’re very proud."

Benefits of ALND include:

Aiding the reader’s diagnosis by indicating the location of suspected lung nodules on chest X-ray images (posteroanterior chest radiographs). The deep-learning technology has been clinically verified in multiple university hospitals and has been approved with a sensitivity of 80% or more. Investigators at these hospitals – Freiburg University Hospital, Freiburg, Germany; Massachusetts General Hospital, Boston, Massachusetts; Samsung Medical Center, Seoul, South Korea; and Severance Hospital, Seoul, South Korea – retrospectively identified 600 chest radiographs with lung cancer and 200 normal chest radiographs.
Extensive external clinical validation that has been recognized by the radiological society for having been performed with ‘unprecedented’ diversity of images acquired under different conditions and demographics, while only producing a small number of false positives per image (0.15).
Providing an option (Autorun) to automatically perform nodule detection immediately after chest X-ray imaging, and providing PACS transmission options to suit the hospital environment, both which simplify a user’s workflow.
Clinical evaluation results have demonstrated that all readers’ nodule detection performances using ALND have increased with statistical significance.

As part of our commitment to advancing diagnostic radiology using AI, Samsung is collaborating with Vuno, a leading developer of AI solutions in healthcare. As part of our collaboration, we will expand the uses of the chest CADe solution and improve the diagnostic accuracy and workflow.

For more information on Samsung’s healthcare business and products, please visit www.SamsungHealthcare.com.

* ALND cannot be used on patients who have lung lesions other than abnormal nodules.

On October 28, 2021 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid") a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), reported its EsoGuard Esophageal DNA Test has been selected as winner of the "Diagnostics Innovation of the Year" award in the inaugural awards program conducted by BioTech Breakthrough, a leading independent market intelligence organization that evaluates and recognizes standout life sciences and biotechnology companies, products and services around the globe (Press release, Lucid Diagnostics, OCT 28, 2021, View Source [SID1234592140]).

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"Lucid Diagnostics is empowering clinicians to save lives by accurately detecting esophageal precancer in an office setting at a stage when it can be effectively managed or treated to prevent progression to highly lethal esophageal cancer"

"We are honored to have Lucid’s EsoGuard recognized as BioTech Breakthrough’s inaugural ‘Diagnostics Innovation of the Year’," said Lishan Aklog M.D., Lucid’s Chairman and Chief Executive Officer. "This award adds to a growing list of accolades and recognition for Lucid’s products, including a prestigious 2020 Edison Best New Product Award, a National Cancer Institute highlight as one of the year’s significant advances in cancer prevention in its 2020 report to Congress, and FDA Breakthrough Device Designation indicating the potential to offer more effective diagnosis or treatment of life-threatening diseases."

"We believe EsoGuard, the first and only commercially available diagnostic test capable of serving as a widespread screening tool to prevent esophageal cancer deaths through early detection of precancer, could have as great an impact as widespread screening has had in preventing breast, colon, and cervical cancer deaths," Dr. Aklog added.

The mission of the annual BioTech Breakthrough Awards program is to conduct the industry’s most comprehensive analysis and evaluation of the top technology companies, solutions, and products in the life sciences and biotechnology industry today. This year’s program attracted more than 1,200 nominations from over 12 different countries throughout the world.

"Lucid Diagnostics is empowering clinicians to save lives by accurately detecting esophageal precancer in an office setting at a stage when it can be effectively managed or treated to prevent progression to highly lethal esophageal cancer," said Bryan Vaughn, Managing Director of BioTech Breakthrough Awards. "Congratulations on being our choice for the ‘Diagnostics Innovation of the Year award."

Gastroesophageal reflux disease (GERD), also known as chronic heartburn, is ubiquitous and can lead to a highly lethal form of esophageal cancer (EAC). Over 80% of EAC patients die within five years of diagnosis, making it the second most lethal cancer in the U.S. The U.S. incidence of EAC has increased 500% over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly all cases, EAC silently progresses until it manifests itself with new symptoms of advanced disease.

All EAC is believed to arise from esophageal precancer which occurs in up to 5% to 15% of at-risk GERD patients. Early esophageal precancer can be monitored until it progresses to late esophageal precancer which can be cured with endoscopic esophageal ablation, reliably halting progression to cancer. Screening is already recommended by clinical practice guidelines in many millions of GERD patients with multiple risk factors, including age over 50 years, male gender, White race, obesity, smoking history, and a family history of esophageal precancer or cancer. Unfortunately, less than 10% of those recommended for screening undergo traditional invasive endoscopic screening. The profound tragedy of an EAC diagnosis is that likely death could have been prevented if the at-risk GERD patient had been screened and then undergone surveillance and curative treatment. The only missing element for a viable esophageal cancer prevention program has been the lack of a widespread screening tool that can detect esophageal precancer. Lucid believes EsoGuard is that missing element.

EsoGuard is a bisulfite-converted next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck. It quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient multicenter case-control study published in Science Translational Medicine and showed greater than 90% sensitivity and specificity at detecting esophageal precancer and cancer. EsoGuard is commercially available in the U.S. as a Laboratory Developed Test (LDT) performed at a CLIA/CAP-certified laboratory. At-risk GERD patients can undergo the EsoCheck procedure for EsoGuard testing at gastroenterology physician offices or at a growing network of Lucid Test Centers.

On October 28, 2021 The Board of Directors of McKesson Corporation (NYSE:MCK) reported a regular dividend of 47 cents per share of common stock (Press release, McKesson, OCT 28, 2021, View Source [SID1234592139]). The dividend will be payable on January 3, 2022, to stockholders of record on December 1, 2021.

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On October 28, 2021 Synthekine Inc., an engineered cytokine therapeutics company, reported it is advancing its IL-2 partial agonist, STK-012, into clinical investigation following clearance of its investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA) (Press release, Synthekine, OCT 28, 2021, View Source [SID1234592138]).

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Synthekine will evaluate STK-012 in a Phase 1a/1b, open-label, multi-center, dose escalation study. The study will investigate STK-012 both as a monotherapy and in combination with an immune checkpoint inhibitor in individuals with advanced solid tumors.

"IL-2 is a cytokine with proven benefit as an anti-cancer therapy. However, the indiscriminate activity of IL-2 can cause severe toxicities, limiting its clinical application," said Naiyer Rizvi, M.D., chief medical officer of Synthekine. "We have designed STK-012 to uncouple the efficacy and toxicity of IL-2, and we look forward to now investigating its potential in our first clinical development program."

STK-012 is designed as an alpha/beta-biased IL-2 partial agonist to selectively stimulate antigen-activated T cells, which are associated with potent anti-tumor activity, and avoid stimulation of toxicity causing immune cells, such as natural killer cells. Synthekine has presented data at AACR (Free AACR Whitepaper) 2021 from preclinical studies demonstrating a mouse surrogate of STK-012 achieved superior tumor regression compared to both wild-type mouse IL-2 and a non-alpha-IL-2 agent, representing a different approach to biasing IL-2. In toxicity models, the mouse surrogate of STK-012, unlike these same comparators, was well tolerated and did not induce capillary leak syndrome (CLS), a dose-limiting IL-2-related toxicity which can result in death. In non-human primate models, STK-012 demonstrated a significantly improved pharmacokinetic and toxicity profile versus both aldesleukin (a recombinant IL-2 therapy) and a non-alpha-IL-2 agent.

On October 28, 2021 Foundation Medicine, Inc. reported that the company has signed agreements for in-network provider status with Humana Military and Health Net Federal Services, which administer the TRICARE health program for military members, retirees and their families (TRICARE).1,2 TRICARE is one of the largest health plans in the United States with 9.6 million beneficiaries (Press release, Foundation Medicine, OCT 28, 2021, View Source [SID1234592137]). Under the new agreements, TRICARE beneficiaries now have improved access to Foundation Medicine’s FDA-approved comprehensive genomic profiling (CGP) tests, FoundationOneCDx and FoundationOneLiquid CDx, in accordance with their approved indications for all solid tumors.

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Through tissue or blood samples, FoundationOne CDx and FoundationOne Liquid CDx evaluate more than 300 genes known to drive cancer growth and identify patients who may be eligible for specific targeted therapies, immunotherapies or clinical trials. In-network coverage of FoundationOne CDx and FoundationOne Liquid CDx testing will support broader access to precision cancer care and may lead to lower out-of-pocket costs for patients who receive any such testing in accordance with their TRICARE policy.

"We believe all patients living with advanced cancer should benefit from comprehensive genomic profiling to inform their care and these agreements are an important step forward in making that happen through improved access to testing," said Brian Alexander, MD, MPH, chief executive officer at Foundation Medicine. "We’re proud to work with Humana Military and Health Net Federal Services to ensure service members, retirees and their families have access to these critical tools in the clinic and can therefore evaluate potential treatment options for their specific cancer."

As the two regional contractors of TRICARE, Humana Military and Health Net Federal Services administer care and manage the broad regional networks of civilian and community providers. The TRICARE program brings together the health care resources of the Military Health System (MHS), including military hospitals and clinics, with a network of civilian health care providers, and provides a robust benefit for military beneficiaries, including active-duty military and their families, as well as military retirees and their families. Foundation Medicine’s agreements with Humana Military and Health Net Federal Services will help bring precision medicine treatment options to more cancer patients across the country.

About FoundationOne Liquid CDx
FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and genomic alteration status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.

About FoundationOne CDx
FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit View Source