On January 13, 2020 Geneoscopy, Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal (GI) health, reported that its preventive screening test for colorectal cancer and precancerous adenomas earned FDA Breakthrough Device Designation (Press release, Geneoscopy, JAN 13, 2020, View Source [SID1234553116]). The agency’s Breakthrough Devices program expedites the development and prioritizes the review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions to provide patients and health care providers with timely access to these technologies.

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Geneoscopy’s preliminary data indicate that its screening test could provide a more effective method for early detection of advanced adenomas, thereby facilitating the removal of precancerous lesions that have the highest propensity for malignant transformation. Geneoscopy’s device could significantly reduce morbidity associated with the second deadliest cancer in the United States by detecting advanced adenomas at a higher rate than existing screening tests and preventing the development of colorectal cancer.

"Reduction in morbidity is the best way to reduce mortality associated with colorectal cancer," said Erica Barnell, CSO of Geneoscopy. "We are excited that the FDA has recognized the potential for Geneoscopy’s test to improve the health of the more than 100 million Americans recommended for colorectal cancer screening."

On January 13, 2020 Illumina, Inc. (NASDAQ:ILMN) reported that it will issue results for fourth quarter and fiscal year 2019 following the close of market on Wednesday, January 29, 2020 (Press release, Illumina, JAN 13, 2020, View Source [SID1234553115]).

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On the same day, at 2:00 pm Pacific Time (5:00 pm Eastern Time) Francis deSouza, President and Chief Executive Officer, and Sam Samad, Senior Vice President and Chief Financial Officer, will host a conference call with analysts, investors, and other interested parties to discuss financial and operating results.

Conference Call Details

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Wednesday, January 29, 2020. Interested parties may access the live teleconference through the Investor Relations section of Illumina’s website under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1 (866) 211-4597, or 1 (647) 689-6853 outside North America, both with Conference ID 2966099.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

On January 13, 2020 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported a strategic collaboration to develop tissue-based companion diagnostics for Amgen’s investigational cancer treatment AMG 510 to identify patients with cancers that have the KRAS G12C mutation (Press release, Qiagen, JAN 13, 2020, View Source [SID1234553114]). The agreement focuses initially on companion diagnostics for non-small cell lung cancer (NSCLC) but allows for further development of the tests for Amgen’s other oncology clinical development programs.

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"We are pleased to support Amgen by building on the success of our therascreen platform to develop a tissue-based companion diagnostic to identify patients who would benefit from AMG510. QIAGEN’s Sample to Insight workflows and experience in developing diagnostic solutions for Precision Medicine are well-suited to help aid in evaluating patients with non-small cell lung cancer," said Thierry Bernard, Interim CEO of QIAGEN and Senior Vice President, Head of the Molecular Diagnostics Business Area. "The success of our long-standing collaboration with Amgen is a demonstration of QIAGEN’s capabilities as a preferred partner of pharmaceutical and biotech companies for the creation of companion diagnostics."

"Amgen is committed to driving broad accessibility to biomarker testing in order to select appropriate patients who will directly benefit from targeted treatments," said David M. Reese, M.D., Executive Vice President of Research and Development at Amgen. "With one in eight patients with NSCLC having KRAS G12C, there’s a critical need to improve access to high quality diagnostics and more routine screening."

The therascreen-based companion diagnostic will screen for KRAS G12C, a genetic mutation that is one of the most common causes of cancer. The RAS gene family, studied for almost 40 years, includes the most frequently mutated oncogenes in human cancers with KRAS being the most prevalent driver mutation in NSCLC.

On January 13, 2020 McKesson Corporation (NYSE:MCK) reported that it will present at the 38th Annual J.P. Morgan Healthcare Conference at the Westin St. Francis Hotel in San Francisco tomorrow, January 14, 2020 at 9:00 AM PT (12:00 PM ET). Brian Tyler, chief executive officer of McKesson, will provide a company overview and review topics including (Press release, McKesson, JAN 13, 2020, View Source [SID1234553113]):

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McKesson’s strategic growth initiatives
McKesson’s differentiated specialty portfolio
Company innovation such as the recent launch of AMP: Access for More Patients
Overview of McKesson’s capital allocation approach
Updated Fiscal 2020 Adjusted Earnings per diluted share outlook: the company now anticipates Adjusted Earnings per diluted share of $14.60 to $14.80 for full-year fiscal 2020, an increase from the previous range of $14.00 to $14.60.
"The focus on executing against our strategic growth initiatives and disciplined capital allocation is reflected in our updated outlook for fiscal 2020. Our businesses are well positioned to continue to deliver growth," said Brian Tyler, chief executive officer. "Based on the continued momentum and trends in our business, we have narrowed and raised our Adjusted EPS guidance range for fiscal 2020."

The live audio webcasts for the J.P. Morgan Healthcare conference will be available on McKesson’s Investor Relations website at View Source McKesson will host a conference call at 8:00 AM ET on February 4, 2020 to discuss third quarter fiscal 2020 financial results. A live audio webcast of the conference call will be available on McKesson’s Investor Relations website, along with the company’s earnings press release, financial tables and slide presentation. The conference call can also be accessed by dialing 786-815-8297. The password is ‘McKesson’.

Adjusted Earnings

McKesson separately reports financial results on the basis of Adjusted Earnings. Adjusted Earnings is a non-GAAP financial measure defined as GAAP income/loss from continuing operations, excluding amortization of acquisition-related intangible assets, transaction-related expenses and adjustments, LIFO inventory-related adjustments, gains from antitrust legal settlements, restructuring, impairment and related charges, and other adjustments as well as the related income tax effects for each of these items, as applicable.

The company does not provide forward-looking guidance on a GAAP basis prospectively as McKesson is unable to provide a quantitative reconciliation of this forward-looking non-GAAP measure to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because McKesson cannot reliably forecast LIFO inventory-related adjustments, gains from antitrust legal settlements, restructuring, impairment and related charges, and other adjustments, which are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially.

On January 13, 2020 Illumina, Inc. (NASDAQ: ILMN), the global leader in DNA sequencing and array-based technologies, and Roche, a global pioneer in pharmaceuticals and diagnostics, reported a 15-year, non-exclusive collaboration agreement to broaden the adoption of distributable next-generation sequencing-based (NGS) testing in oncology (Press release, Illumina, JAN 13, 2020, View Source [SID1234553112]). As the understanding of genomic drivers of cancer evolves, NGS has the potential to transform cancer risk prediction, detection, diagnosis, treatment and monitoring.

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This agreement brings together complementary capabilities of each company to broaden global adoption of NGS in cancer care. As part of this agreement, Illumina will grant Roche rights to develop and distribute in-vitro diagnostic (IVD) tests on Illumina’s NextSeq 550Dx System, as well as on its future portfolio of diagnostic (Dx) sequencing systems, including the forthcoming NovaSeqDx. Roche will in turn collaborate with Illumina to complement Illumina’s comprehensive pan-cancer assay, TruSight Oncology 500 (TSO 500), with new companion diagnostic (CDx) claims. The financial terms of the deal were not disclosed.

Under the IVD terms of the agreement, Roche will develop, manufacture and commercialize AVENIO IVD tests for both tissue and blood for use on Illumina’s NextSeq 550Dx System. Illumina will continue to sell the NextSeq 550Dx Systems and core sequencing consumables. Under the CDx terms of the agreement, Illumina and Roche will develop tests and pursue CDx claims on TSO 500 for both existing and pipeline oncology targeted therapies on the NextSeq 550Dx System. Illumina will lead the development and regulatory approval process, and will continue to manufacture, supply and commercialize TSO 500. Roche will support the development of the claims and regulatory filings.

"We are excited Roche has selected Illumina’s sequencers as their platform of choice to accelerate the adoption and broaden the reach of oncology-based, distributable IVD tests into clinical care," said Francis deSouza, CEO of Illumina. "This partnership complements and strengthens our strategy to establish TSO 500 as a comprehensive NGS panel for cancer therapies by expanding the supported set of CDx claims on this universal panel. Building on the momentum of other recently established diagnostic and pharmaceutical partnerships, together we aim to advance critical access to NGS testing to improve patient outcomes."

Illumina’s TSO 500 is a comprehensive pan-cancer assay designed to identify known and emerging tumor biomarkers. TSO 500 utilizes both DNA and RNA from tumor samples to identify key somatic variants underlying tumor progression, such as small DNA variants, fusions and splice variants. When used to test for companion diagnostics claims, TSO 500 is poised to identify cancer patients globally who might benefit from targeted therapeutics. As the anchor tenant of Illumina’s oncology product portfolio, TSO 500 enables labs to adopt a comprehensive genomic profiling panel, in a decentralized testing model, leveraging the accurate and reproducible results of Illumina’s diagnostic sequencing systems.