Quest Diagnostics Updates Outlook For Full Year 2021

On September 9, 2021 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported its financial outlook for full year 2021 (Press release, Quest Diagnostics, SEP 9, 2021, View Source [SID1234587568]).

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Since the company reported its financial performance for the second quarter of 2021 on July 22, 2021, COVID-19 molecular testing volumes were stronger than anticipated through the end of August and are expected to continue to be stronger than anticipated because of the surge of the Delta variant. The low end of the company’s outlook now assumes average COVID-19 volumes of at least 40,000 molecular tests per day for the second half of the year. Organic testing volumes in the company’s base business (excluding COVID-19 molecular and antibody testing and the impact of recent acquisitions) remain consistent with its previous outlook.

Updated Outlook for Full Year 2021

The company revised its full year 2021 outlook as follows:

The company is scheduled to participate in the Morgan Stanley 19th Annual Global Healthcare Conference today at 9:30 a.m. Eastern Time. The presentation will be webcast live during the conference and will be available on the company’s investor relations page which can be accessed at ir.QuestDiagnostics.com. During the discussion, the company’s management plans to discuss the company’s vision, goals and two-point strategy to accelerate growth and drive operational excellence, as well as the company’s current perspective on the impact of the COVID-19 pandemic.

Management continues to believe that the COVID-19 pandemic’s impact on its future operating results, cash flows and/or financial condition will be primarily driven by a number of factors beyond the company’s knowledge and control, including: the pandemic’s severity and duration; healthcare insurer, government, and client payer reimbursement rates for COVID-19 molecular tests; the pandemic’s impact on the U.S. healthcare system and the U.S. economy; and the timing, scope and effectiveness of federal, state and local governmental responses to the pandemic including the impact of vaccination efforts.

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP operating performance measures that exclude special items such as restructuring and integration charges, certain financial impacts resulting from the COVID-19 pandemic, amortization expense, excess tax benefits ("ETB") associated with stock-based compensation, costs associated with donations, contributions and other financial support through Quest for Health Equity, the company’s initiative with the Quest Diagnostics Foundation to reduce health disparities in underserved communities, a gain on the sale of an ownership interest in a joint venture and other items.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts; and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional table attached below includes a reconciliation of non-GAAP adjusted measures to GAAP measures.

OncoBeta initiates international EPIC-Skin study with Rhenium-SCT® for the treatment of Skin Cancer

On September 9, 2021 OncoBeta GmbH, a medical device company specialized in innovative epidermal radioisotope therapies reported the initiation of a phase IV international multi-centre study evaluating the Complete Response Rate of patients with non-melanoma skin cancer after treatment with Rhenium-SCT (Press release, OncoBeta, SEP 9, 2021, View Source [SID1234587567]).

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The EPIC Skin study (Efficacy of Personalised Irradiation with Rhenium-SCT- for the treatment of non-melanoma skin cancer) is based on the proven effect of the ß-emitter rhenium-188 in the treatment of basal cell (BCC) and squamous cell carcinomas (SCC)1,2. The Aim of the study is to further evaluate the efficacy of Rhenium-SCT as well as important Patient Reported Outcome Measures such as quality of life, treatment comfort and cosmetic outcomes.

OncoBeta has contracted the Australian based Contract Research Organization (CRO) Molecule2Market (M2M) for this significant international, multicentre clinical study (www.molecule2.com.au).

The study will enrol a minimum number of 175 adult patients with a confirmed histologically of stage I or II non-melanoma skin cancer to participate for 12 months, with a follow up period to 24 months. Study centres participating in the initiative are located in Australia, Austria, Germany and the United Kingdom. Enrolment for the EPIC-Skin trial is expected to open as soon as November 2021.

Dr. Gerhard Dahlhoff, Medical Director at OncoBeta GmbH stated: "Rhenium-SCT has proven to be effective and safe in previous studies. With this new study we want to further evaluate the efficacy and safety of the Rhenium-SCT at an international level in NMSC patients. This will be done in different centres under the same conditions."

"The initiation of the EPIC-Skin Study is a significant milestone for the Rhenium-SCT", said Shannon D. Brown III, CEO and Managing Director at OncoBeta GmbH "This will further demonstrate how effective and safe this therapy is. Furthermore, aligning with our company vision of focussing on quality of life, this study will also report on outcomes from the patient’s perspective."

About the Rhenium-SCT (Skin Cancer Therapy)
Non-melanoma skin cancer (NMSC) is the most common form of cancer in humans. The most common cause of NMSC is sun exposure, while other predisposing factors include genetic skin conditions and immunosuppressive diseases or treatments. The Rhenium-SCT is a non-invasive procedure, painless therapy3 providing for unparalleled aesthetic results2,4, even in cases otherwise considered difficult to treat.

The Rhenium-SCT utilizes the radioisotope Rhenium-188 in an epidermal application with optimal properties for the treatment of NMSCs (non-melanoma skin cancers). The specially designed device ensures the Rhenium-SCT compound never comes in direct contact with the patients’ skin and the application is safe and www.oncobeta.com simple for the applying physician. Most cases of non-melanoma skin cancers (Basal Cell Carcinomas and Squamous Cell Carcinomas) can be treated using the Rhenium-SCT in one single session3. Scar-free healing4 of the treated lesion area and the regeneration of healthy tissue occurs usually within a few weeks after treatment4.

Thermo Fisher Scientific to Host Virtual Investor Day

On September 9, 2021 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that it will host a virtual Investor Day on Friday, September 17, 2021, starting at 9:00 a.m. and expected to conclude by 11:00 a.m. (EDT) (Press release, Thermo Fisher Scientific, SEP 9, 2021, View Source [SID1234587566]).

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The virtual format will feature presentations by members of Thermo Fisher Scientific’s senior management team and conclude with a Q&A session.

You can access the live webcast of the presentation via the Investors section of our website, www.thermofisher.com. A replay of the webcast will be available following the presentation.

Ambrx to Participate in Panel Discussion at the H.C. Wainwright 23rd Annual Global Investment Conference

On September 9, 2021 Ambrx (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, reported that Feng Tian, Ph.D., President and Chief Executive Officer of Ambrx, will participate in a virtual panel discussion at the H.C. Wainwright 23rd Annual Global Investment Conference, taking place September 13-15, 2021 (Press release, Ambrx, SEP 9, 2021, View Source [SID1234587557]). The discussion will be led by Michael King, Managing Director and Senior Biotechnology Analyst at H.C. Wainwright.

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Discussion Topic: Engineered Cytokines: The Next Big Wave in Immuno-Oncology.
Date and Time: Tuesday, September 14, 2021, at 1:30 pm EDT, 10:30 am PDT.

Individuals interested in listening to the panel discussion may do so using the webcast link under "Latest Events" in the Investors section of the company’s website at: www.ambrx.com.

ITM to Host Virtual Symposium at the ESMO Congress 2021 with Key Neuroendocrine Tumor Experts on September 17, 2021

On September 9, 2021 ITM AG, a leading radiopharmaceutical company, reported that it will host a virtual industry satellite symposium titled, "A Global Perspective on the Management of Neuroendocrine Tumors – the Evolving Role of Targeted Radionuclide Diagnostics and Therapy" at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 (Press release, ITM Isotopen Technologien Munchen, SEP 9, 2021, View Source [SID1234587556]). The symposium will feature renowned key opinion leaders in the field and will be held on Friday, September 17th, 2021, from 10:30 am – 12:00 pm CEST on channel 3, open to ESMO (Free ESMO Whitepaper) registered participants.

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The speakers are key precision oncology experts and will lead critical discussions addressing the changes within the treatment and diagnosis of neuroendocrine tumors. They will cover a range of topics examining the impact of NET diagnostic paradigms, treatment guidelines, and recent advancements within the clinical studies of Targeted Radionuclide Therapy. In addition to the ongoing COMPETE trial, the new phase III trial COMPOSE, a prospective study in high Grade 2 and Grade 3 gastroenteropancreatic NETs, will be presented. Participants will be able to interact with the speakers in a Q&A session at the end of the event.

Scientific Program and Participating Experts:

Welcome & Introduction
Raj Srirajaskanthan, MD, FRCP King’s College Hospital, London, UK (5 mins)
Changes in the Incidence and Prevalence of NETs – Impact of New Diagnostic Paradigms
Simon Singh, MD, MPH Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Canada (20 mins)
The Evolution of Guidelines for the Treatment of NETs
Namrata Vijayvergia, MD, FACP Fox Chase Cancer Center, Philadelphia, U.S. (20 mins)
The Role of Targeted Radionuclide Therapy in Clinical Trials
Grace Kong, MBBS (Hons), FRACP, FAANMS Peter MacCallum Cancer Center, Melbourne, Australia (20 mins)
Q&A and Closing Remarks (25 mins)
For further information please visit ITM’s ESMO (Free ESMO Whitepaper) 2021 Symposium website or the official ESMO (Free ESMO Whitepaper) webpage.