On May 26, 2020 Mauna Kea Technologies (Paris:MKEA) (OTCQX:MKEAY) (Euronext: MKEA) inventor of Cellvizio, the multidisciplinary probe- and needle-based confocal laser endomicroscopy (pCLE/nCLE) platform, reported that the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Technology and Value Assessment Committee (TAVAC) published a review on the safety and efficacy of confocal laser endomicroscopy as a diagnostic tool for the evaluation of gastrointestinal pathologies (Press release, Mauna Kea Technologies, MAY 26, 2020, View Source [SID1234558493]). This article, entitled "SAGES TAVAC safety and efficacy analysis confocal laser endomicroscopy," was published in a peer reviewed international journal, Surgical Endoscopy (doi.org/10.1007/s00464-020-07607-3).

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SAGES TAVAC publishes Technology Alerts on a monthly basis and longer safety and efficacy reviews on a periodic basis. The publication in Surgical Endoscopy was based on TAVAC’s systematic review of clinical studies on PubMed/Medline involving CLE in May 2018 as well as bibliographies of key references for relevant studies not available on PubMed. TAVAC’s objective was to evaluate the safety, value, and efficacy of CLE in the gastrointestinal tract. The results of TAVAC’s analysis concluded that CLE offers an excellent safety profile with rare adverse events related to the use of fluorescent agents. It has been shown to increase the detection of dysplastic Barrett’s esophagus, gastric intraepithelial neoplasia/early gastric cancer, and dysplasia associated with inflammatory bowel disease when compared to standard screening protocols. It also aids in the differentiation and classification of colorectal polyps, indeterminate biliary strictures, and pancreatic cystic lesions.

"The process of the TAVAC review and experience of the Committee members show that Cellvizio has an excellent safety profile and clear clinical utility and efficacy as an adjunct to the standard of care across a range of gastrointestinal diseases and conditions," said Shawn Tsuda, MD, FACS, board-certified surgeon and Chair of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Technology and Value Assessment Committee (TAVAC). "Early diagnosis and effective surveillance can have significant positive impacts on therapeutic management, and Cellvizio is an essential tool to improve diagnostic accuracy and reduce inappropriate interventions."

"We are extremely pleased by SAGES’s endorsement of Confocal Laser Endomicroscopy in the diagnosis and surveillance of gastrointestinal diseases including GERD, Barrett’s Esophagus, and pancreatic cysts," said Robert L. Gershon, Chief Executive Officer of Mauna Kea Technologies. "This peer reviewed analysis reinforces the position of Cellvizio as an adjunct to the standard of care to effectively target biopsies and increase diagnostic yield, thereby improving patient outcomes and optimizing clinical costs through increased diagnostic accuracy."

In their analysis, the Committee outlined the high diagnostic accuracy of CLE as an advanced imaging adjunct across all gastrointestinal endoscopic indications compared to current standard of care. They also highlighted the improvement of diagnostic yield for specific indications such as chronic GERD, Barrett’s Esophagus, early gastric cancer, gastric intestinal neoplasia, and pancreatic cystic lesions, as well as the effectiveness for evaluation and ongoing surveillance of inflammatory bowel disease (IBD).

One important consideration for endorsement of a new technology for gastrointestinal disease diagnosis is its potential for reducing inappropriate or unnecessary therapy for non-neoplastic conditions, therefore improving overall procedure-related complications, optimizing surveillance intervals, reducing unnecessary interventions, and limiting histological analysis of insignificant lesions while detecting early dysplasia to improve patient outcomes.

About SAGES
SAGES (The Society of American Gastrointestinal and Endoscopic Surgeons) was founded in 1981 to foster, promote, support and encourage academic, clinical and research achievement in gastrointestinal endoscopic surgery. SAGES currently boast more than 6,500 general surgeon members from countries all around the world. SAGES annual meeting is oriented toward minimally invasive surgery and in 2018 had an attendance of over 2,700 surgeons.

On May 26, 2020 precision oncology company Lucence reported that it will be presenting data this week demonstrating high sensitivity of its liquid biopsy technology in detecting clinically relevant biomarkers in lung cancer, alongside promising data in breast and blood cancers (Press release, Lucence, MAY 26, 2020, View Source [SID1234558492]). The data, presented as part of ASCO (Free ASCO Whitepaper)’s Virtual Scientific Program, show the Company’s AmpliMARK technology detection capability for recommended biomarkers with 97.4% concordance between two orthogonal liquid biopsy platforms in lung cancer. The Company is planning to make its LiquidHALLMARK test, powered by AmpliMARK, commercially available in the United States later this year for biomarker detection in lung cancer patients.

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Clinical utility of a liquid biopsy diagnostic approach in lung cancer using amplicon-based next-generation sequencing in parallel with allele-specific PCR presents data from a multinational study examining real-world diagnostic outcomes of Lucence’s liquid biopsy technology in 374 lung cancer patients. Patients who were tested with an innovative combination of two blood-based liquid biopsy platforms achieved a one-day result for a key treatment decision, together with a subsequent comprehensive analysis of recommended markers, with a 97.4% concordance between the two platforms. This study highlights that ultrasensitive blood-based liquid biopsy is a key platform to support lung cancer diagnosis and appropriate treatment selection.

Ultrasensitive multiplex detection of structural rearrangements in ALK, RET, ROS1 and PD-L1 using a comprehensive next-generation sequencing assay, #302, will be presented on Friday, May 29th from 8:00-11:00 am Eastern Time in a virtual session. This poster reports AmpliMARK’s high sensitivity in detecting cancer-related structural variants in cfDNA samples from lung cancer patients, cfDNA samples from lymphoma patients, and tumor tissue DNA samples from natural killer(NK)/T-cell lymphoma patients. A second poster, Detection of actionable gene mutations in breast cancer by amplicon-based next-generation sequencing liquid biopsy, #120, reports AmpliMARK’s high sensitivity in detecting key PIK3CA, ESR1 and other driver gene mutations non-invasively in plasma cfDNA of breast cancer patients in a multinational study.

These new studies suggest that the LiquidHALLMARK liquid biopsy test, powered by amplicon-based sequencing technology AmpliMARK, has the potential to shift the paradigm in precision oncology. LiquidHALLMARK offers highly sensitive, target-rich insights into established biomarkers spanning 80 gene mutations and 10 gene fusions in 15 cancer types (available in the United States starting Q3 2020 for investigational use only). The data showcase AmpliMARK’s excellent performance in rapidly detecting multiple somatic variants, highlighting the technology’s potential to deliver fast insights for clinicians to develop the most effective treatment plans for patients.

To adapt to the virtual format of ASCO (Free ASCO Whitepaper)20, Lucence has created an online hub at lucence.com/asco2020. Attendees can book a meeting with the Lucence team, see a complete list of posters and abstracts, and register for a webinar on COVID-19 and lung cancer presented by the Singapore Society of Oncology, taking place on June 4th, 2020 at 5 PM Pacific Time/8 PM Eastern Time and June 5th at 8 AM GMT+8.

On May 26, 2020 Freenome, a privately held biotechnology company that has pioneered a comprehensive multiomics platform for early cancer detection with a routine blood draw, reported that several new developments: initiating its PREEMPT CRC clinical trial; adding Gary Reedy, CEO of the American Cancer Society, to the Board of Directors; and appointing William Quirk as the Chief Financial Officer (Press release, Freenome, MAY 26, 2020, View Source [SID1234558491]).

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"Following strong data presented at ASCO (Free ASCO Whitepaper)-GI, which demonstrated 91% sensitivity (94% in Stage I/II patients) with 94% specificity for colorectal cancer (CRC), we are initiating the pivotal trial for our blood-based CRC test," said CEO, Gabriel Otte. "More recent studies using our multiomics platform have revealed that different biomarkers are required for the detection of precancerous polyps versus CRC, and the availability of a blood test with adenoma detection rates as good or better than any known fecal test will meaningfully improve patient adherence and revolutionize CRC screening," added Chief Medical Officer, Dr. Girish Putcha.

PREEMPT CRC is Freenome’s prospective clinical trial that will enroll 14,000 individuals to validate its multiomics blood test for CRC screening and FDA approval. The study will include asymptomatic, average-risk patients between the ages of 45 and 85 undergoing a screening colonoscopy.

"In conjunction with the initiation of PREEMPT CRC, we are delighted that Gary Reedy has joined our Board of Directors as an observer," said Mr. Otte. "Gary’s 40+ years of fighting cancer makes him an ideal partner in our mission of making cancer screening tests accessible for everyone and improving patient adherence to cancer screening guidelines."

"It is incredibly important to improve CRC screening rates as much as possible," said Reedy. "The National Colorectal Cancer Roundtable has set a goal of 80% screening adherence in every community. If Freenome’s multiomics approach can help us achieve that goal, it would be wonderful. This is why our BrightEdge impact fund has chosen to invest in Freenome’s work."

Mr. Reedy became Chief Executive Officer of the American Cancer Society in April 2015, but his work with the organization began more than 20 years ago, when he first became a volunteer leader with the organization. Prior to his work with the ACS, Mr. Reedy had a distinguished 37-year career as a healthcare business and advocacy leader, most recently as Worldwide Vice President, Government Affairs and Policy, at Johnson & Johnson. Previously, Mr. Reedy held senior leadership positions with SmithKline Beecham, Centocor, and Johnson & Johnson. Mr. Reedy is a graduate of Emory & Henry College and holds an honorary Doctor of Humane Letters degree from Arcadia University.

"We are also happy to announce Bill Quirk has joined Freenome as our CFO," said Mr. Otte. "Bill’s extensive background covering the diagnostics industry for nearly 20 years, including his experience in helping growth companies raise capital, makes him a great addition to our team."

"Freenome has the rare combination of exceptional science and a mission-driven culture, which positions us to have a profound impact on human health," said Mr. Quirk. "I’m excited to join Freenome at such a meaningful point in our development."

Prior to joining Freenome, Mr. Quirk served as a managing director in the equity research division of Piper Sandler, a full-service investment bank. Mr. Quirk received a Bachelor’s of Business Administration from Saint Norbert College, an MBA from the University of Minnesota’s Carlson School of Management, and holds the CFA designation.

On May 26, 2020 AmerisourceBergen, a global healthcare solutions leader, reported that it has been selected by Deciphera Pharmaceuticals (Deciphera) to support QINLOCK (ripretinib) (Press release, AmerisourceBergen, MAY 26, 2020, View Source [SID1234558490]). AmerisourceBergen is providing a unified commercialization approach for QINLOCK which was approved by the U.S. Food and Drug Administration (FDA) on Friday, May 15, 2020. QINLOCK is an orally administered kinase switch control inhibitor approved for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

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In the United States, there are an estimated 4,000 to 6,000 cases of GIST, a rare form of cancer, diagnosed annually.1 The gastrointestinal cancer is characterized by disease-related symptoms, including vague abdominal pain, early feelings of fullness, vomiting and fatigue due to anemia.2 About 40-70% of GISTs are found in the stomach, 20-40% in the small intestine, 5-15% in the colon and rectum, and in rare cases, the esophagus (<5%).3 QINLOCK is a tyrosine kinase switch control inhibitor that was engineered to broadly inhibit KIT and PDGFRα mutated kinases, where genetic mutations or alterations in these kinases play a crucial role in the biology of these tumors leading to drug-resistance and disease progression.4

"At AmerisourceBergen, we believe we have a responsibility to help create healthier futures – for patients and our partners. The opportunity to work with Deciphera and support the launch of QINLOCK is the perfect example of how our integrated services work together to fulfill that purpose," said Jenny Fallone, Director, Global Branded & Specialty Sourcing, AmerisourceBergen. "We are proud that Deciphera selected us to help ensure patients affected by this rare disease – who have exhausted other treatments – have a new therapeutic option. By working together, we can accelerate product performance but, most importantly, increase patient access to this innovative treatment."

AmerisourceBergen’s established expertise in supporting rare disease treatments helps ensure that critical medications are safely delivered from manufacturers to patients every day. AmerisourceBergen is supporting QINLOCK through:

Specialty distribution: ASD Healthcare – one of the nation’s largest specialty pharmaceutical distributors that provides services to 95 percent of U.S. hospitals, as well as specialty pharmacies, outpatient dialysis clinics, hemophilia treatment centers, home healthcare companies and retail pharmacies – will support the distribution of QINLOCK to approved hospitals, specialty pharmacies and government entities. Oncology Supply, also a part of AmerisourceBergen, provides specialty distribution to independent oncology practices nationwide and will support the distribution of QINLOCK to oncology practices and clinics for in office dispensing.
GPO contracting for community oncology: AmerisourceBergen provides GPO contracting, integrated dispensing solutions and expertise through ION Solutions, the largest physician service organization and group purchasing organization specializing in the support of independent, community oncology practices.
Third-party logistics: ICS, a pharmaceutical third-party logistics provider, aims to increase supply chain efficiency and ensure commercial success for this product. ICS will support distribution to specialty pharmacies and distributors and provide full order-to-cash services.
Dispensing: AmerisourceBergen’s specialty pharmacy US Bioservices has more than 25 years of experience supporting small patient populations and is dispensing QINLOCK. The pharmacy also provides customized clinical care, focused on supporting adherence and patient outcomes. Physicians may submit prescriptions for this medication to US Bioservices via phone (877-757-0667), fax (888-899-0067), ePrescribe or the MyPathpoint Prescriber Portal.
AmerisourceBergen’s unified approach is supported by world-class commercialization support services – from global clinical trial and specialty logistics to patient access and adherence. By offering assistance at all stages of the product life cycle, AmerisourceBergen enables manufacturers to stay focused on developing life-saving therapies, while also having the confidence that their developments are expertly commercialized and brought to patients in need.

On May 26, 2020 Kronos Bio, Inc., dedicated to drugging transcriptional regulatory networks in cancer, reported that Norbert Bischofberger, Ph.D., President and Chief Executive Officer will present at the Jefferies Virtual Healthcare Conference taking place June 2-4, 2020 (Press release, Kronos Bio, MAY 26, 2020, View Source [SID1234558489]).

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Presentation Date: Wednesday, June 3, 2020
Presentation Time: 4:30 PM ET

A webcast will be made available on the Company’s website at www.kronosbio.com in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.