On April 23, 2019 OmniSeq, a CAP-accredited, molecular diagnostics spin-out of Roswell Park Comprehensive Cancer Center, and LabCorp (NYSE: LH), a leading global life sciences company, reported an extension of their exclusive distribution agreement as well as an additional investment by LabCorp (Press release, OmniSeq, APR 23, 2019, View Source [SID1234535323]). The distribution agreement and LabCorp’s initial investment in OmniSeq’s Series B financing round were first announced in August 2017.

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The distribution agreement originally provided LabCorp with exclusive distribution rights for the OmniSeq Comprehensive and Immune Report Card clinical assays. The agreement’s extension adds OmniSeq Advance, as well as the OmniSeq MSI NGS test. Together, OmniSeq’s next-generation sequencing (NGS)-based assays provide comprehensive genomic and immune profiling to enable oncologists to select the most appropriate therapies or clinical trials for each patient. Pursuant to the agreement, OmniSeq’s suite of advanced tests will be exclusively offered by LabCorp to U.S.-based physicians through Integrated Oncology, a member of the LabCorp Specialty Testing Group, and globally to biopharmaceutical customers through Covance, LabCorp’s drug development business.

Proceeds from LabCorp’s additional investment will be used by OmniSeq to pursue FDA approval or clearance of its proprietary NGS-based comprehensive genomic and immune profiling panels, to continue the development of new panels intended to predict the response to checkpoint inhibitors and other immune-therapies, and to support the expansion of testing operations.

According to Mark Gardner, CEO of OmniSeq, "We are honored to extend our partnership with LabCorp to expand access to OmniSeq’s advanced testing methodologies to help provide more precise guidance in the selection of the right therapy or clinical trial for patients diagnosed with a broad range of cancers. With LabCorp’s continued collaboration and support, we will have the funding to augment the clinical utility of our testing services, and to make the best of precision medicine more readily available to physicians and patients across the U.S. and to biopharmaceutical companies around the globe."

"OmniSeq has been an excellent partner for us in both clinical studies and clinical diagnostics," said Marcia Eisenberg, chief scientific officer of LabCorp Diagnostics, and a member of OmniSeq’s board of directors. "Working together, we have brought advanced NGS-based diagnostics to market, supporting more informed clinical decisions for targeted and immuno-oncology therapies. By combining the clinical trials capabilities of Covance, the single-source lab solutions services of Integrated Oncology, and the testing services of OmniSeq, LabCorp is uniquely positioned to bring precision medicine to oncology patients across the country."

To learn more about OmniSeq Comprehensive, Immune Report Card, OmniSeq AdvanceSM, or OmniSeq MSI NGS, call 1-800-781-1259 or visit www.omniseq.com.

On April 23, 2019 ExCellThera Inc., an advanced clinical stage biotechnology company delivering molecules and bioengineering solutions to expand stem and immune cells for therapeutic use, reported that the U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to its lead technology, ECT-001, in the treatment of hematologic malignancies (Press release, ExCellThera, APR 23, 2019, View Source [SID1234535340]). The RMAT designation is based on strong data from Phase I/II clinical trials using ECT-001 to expand stem and immune cells for the treatment of blood cancers.

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RMAT designation is granted by the FDA under the 21st Century Cures Act for cell therapies, tissue-engineered or similar products intended to treat or cure a serious disease, and which demonstrate preliminary evidence to address an unmet clinical need. It accords all the benefits of the FDA’s fast track and breakthrough therapy designation programs, including an ability to interact with the agency to discuss the potential acceleration of regulatory approval. Under the auspices of the RMAT designation, FDA will work closely with ExCellThera and provide advice on generating the evidence needed to support approval of ECT-001 in an efficient manner.

"The FDA’s RMAT designation is a clear signal of confidence in the potential of our lead cell therapy drug product, ECT-001, to treat patients with hematologic malignancies," said Dr. Guy Sauvageau, CEO and founder of ExCellThera. "We look forward to working with the FDA within the RMAT framework to advance ECT-001 through the final phases of clinical development in an expedited manner."

Various clinical studies using ECT-001 are currently ongoing in the treatment of multiple myeloma, high-risk leukemia and other hematologic malignancies. In addition, ExCellThera plans to initiate additional clinical trials, including a pivotal trial in the United States and Canada, in the coming months. ECT-001 has also received FDA orphan drug designation for the prevention of graft-versus-host disease.

About ECT-001
The ECT-001 technology is a combination of a small molecule, UM171, and an optimized culture system. The technology, capable of expanding the number of stem and immune cells exponentially in as little as seven days, is used in novel curative cord blood transplant therapies for patients with blood cancers, allowing rapid engraftment, greatly reduced incidence of transplant-related mortality, low risk of chronic graft-versus-host disease and low risk of relapse, resulting in better outcomes for patients.

On April 23, 2019 Varian (NYSE: VAR) reported that The Nairobi West Hospital in Nairobi, Kenya is the first clinic in the country and in West, Central, and East Africa to begin treating cancer patients using the Halcyon radiotherapy system (Press release, Varian Medical Systems, APR 23, 2019, View Source [SID1234535324]). The Halcyon system simplifies and enhances virtually every aspect of image-guided volumetric intensity-modulated radiotherapy (IMRT), including improved patient comfort and shortening the time from installation to first-treatment without sacrificing quality. The system is well suited to treat a majority of cancer patients, offering advanced treatments for lung, prostate, breast, head & neck, and many other forms of cancer.

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The Halcyon system features a streamlined workflow that only requires nine steps from the start to the end of treatment compared to up to more than 30 steps with older technologies thereby reducing the total treatment time. To assist in the reduction of time and construction costs from installation to first patient treatment, Halcyon offers expedited commissioning, requires less shielding than traditional systems, can fit in the majority of existing small vaults, and can be installed in two weeks or less.

"The installation and treatments on the Halcyon system is a major achievement for patients and cancer care delivery in Kenya and in the region," said Sukhmeet Sandhu, chief executive officer, The Nairobi West Hospital. "The streamlined workflow and the advanced capabilities of the Halcyon system will have a positive impact on the increased number of cancer patients we can treat every year."

"At Varian we believe that by increasing access to advanced cancer care we can move closer to achieving a world without fear of cancer," said Jean-Luc Devleeschauwer, president, Varian Oncology Systems EMEIA. "We are proud of our collaboration with The Nairobi West Hospital on the installation of the Halcyon system. The whole process from our first meeting, to treatment room construction, to installation and staff training, only took nine months. I commend the Nairobi West Hospital and Varian teams for quickly bringing this advanced treatment capability to cancer patients in Kenya and the region."

On April 23, 2019 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported financial results for the first quarter ended March 31, 2019 (Press release, Quest Diagnostics, APR 23, 2019, View Source [SID1234535341]).

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"We’re off to a good start in 2019, with solid volume growth from our expanded health plan access," said Steve Rusckowski, Chairman, President and CEO. "As we anticipated, volume accelerated through the quarter, and we look forward to continued progress as a member of UnitedHealthcare’s Preferred Lab Network beginning July 1. We continue to drive productivity to address ongoing reimbursement pressure, and are well positioned to meet our financial commitments for the remainder of 2019."

For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage of net revenues, net income attributable to Quest Diagnostics, and diluted EPS, see note 2 of the financial tables attached below.

Beginning in 2019, the company has changed how it presents adjusted income measures to additionally exclude amortization expense for all periods. We believe this presentation provides investors with additional insight to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business.

Outlook for full-year 2019

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under the 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, amortization expense, excess tax benefit ("ETB") associated with stock-based compensation, 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 tables attached below include reconciliations of adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, passcode: Investor; or via live webcast on the Company’s website at www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-480-3547 for domestic callers or 203-369-1551 for international callers. No passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on April 23, 2019 until midnight Eastern Time on May 7, 2019. Anyone listening to the call is encouraged to read the company’s periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On April 23, 2019 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer, reported that the United States Food and Drug Administration (FDA) has granted orphan drug designation to autologous enriched T-cells genetically modified with a retroviral vector to express two chimeric antigen receptors targeting CD19 and CD22 (AUTO3) for the treatment of acute lymphoblastic leukemia (ALL) (Press release, Autolus, APR 23, 2019, View Source [SID1234550819]).

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According to the National Institute of Health’s National Cancer Institute, in the United States, there will be an estimated 5,930 new cases of ALL and an estimated 1,500 related deaths in 2019. Patients are predominantly children; approximately 60% of cases occur at age < 20 years. ALL occurs when the bone marrow makes too many immature lymphocytes, which are a type of white blood cell. Despite a high rate of response to induction chemotherapy, only 30–40% of adult patients with ALL will achieve long-term remission. Similarly, pediatric patients typically respond well to first-line treatment (combination chemotherapy) but 10 to 20% of total patients relapse with chemotherapy-resistant disease, leading to a significant unmet need in pediatric patients with high-risk relapsed or refractory ALL.

"We are pleased to receive orphan drug designation for AUTO3 for acute lymphoblastic leukemia," said Dr. Christian Itin, chairman and chief executive officer of Autolus. "Earlier this year, we presented encouraging updated data from the AMELIA phase 1/2 trial of AUTO3 in pediatric ALL patients. We believe that AUTO3 has the potential to be a best in class therapy in pediatric ALL by addressing antigen escape, a common cause of relapse in these patients. AUTO3 may also provide an improved safety profile over currently marketed CAR T therapies with low levels of severe CRS and neurotoxicity observed in clinical studies."

Orphan drug designation is granted by the FDA Office of Orphan Products Development to drugs and biologics which are intended for the treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Under the Orphan Drug Act, the FDA may provide grant funding toward clinical trial costs, tax advantages, FDA user-fee benefits, and seven years of market exclusivity in the United States following marketing approval by the FDA. For more information about orphan designation, please visit the FDA website at www.fda.gov.

About AUTO3
AUTO3 is a programmed T cell therapy containing two independent chimeric antigen receptors targeting CD19 and CD22 that have each been independently optimized for single target activity. By simultaneously targeting two B cell antigens, AUTO3 is designed to minimize relapse due to single antigen loss in patients with B cell malignancies. AUTO3 is currently being tested in pediatric ALL in the AMELIA clinical trial and in diffuse large B cell lymphoma in the ALEXANDER clinical trial.

For more information about the AMELIA trial, visit www.ClinicalTrials.gov (NCT03289455). For more information about the ALEXANDER trial, visit www.ClinicalTrials.gov (NCT03287817).