On January 14, 2020 Genomic Testing Cooperative, LCA (GTC), a cooperative (Co-Op) company offering comprehensive genomic profiling of hematologic and solid tumors, and C2i Genomics, Inc, a tumor pattern recognition liquid biopsy company, reported collaboration to develop liquid biopsy tests for the staging and monitoring of solid tumors (Press release, Genomic Testing Cooperative, JAN 14, 2020, View Source [SID1234553208]). C2i Genomics approach is based on proprietary technology using AI-based pattern recognition of whole genome sequencing of cell-free DNA (cfDNA). The technology will be adapted by GTC and distributed to the Co-Op members upon completion of technical and clinical validation. This technology will be used for highly accurate personalized monitoring of patients with various types of cancer. The initial focus of this collaboration will be on cancers of the lung, colon, breast, and melanoma.

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Dr. Asaf Zviran, C2i Genomics Chief Executive Officer and Chief Scientific Officer stated, "We are delighted to be working with GTC to transition our technology from the research and development phase into a real-world clinical diagnostic test. Using our liquid biopsy approach to more sensitively and accurately stage and monitor patients with early stage cancer addresses an unmet need and we believe that the extensive experience of the team at GTC in developing and validating new clinically actionable tests will significantly accelerate bringing this innovation to patient care."

Dr. Maher Albitar, GTC Chief Executive Officer and Chief Medical Officer, said, "We believe that broad whole genome pattern recognition of genomic abnormalities is a reliable approach for cancer patients staging and monitoring. Working on the clinical development of this type of testing with C2i Genomics is aligned with GTC’s mission as an innovation company focused on expanding the use of genomics in improving patient care."

As part of the agreement, GTC will perform sequencing and participate in the efforts of technical and clinical validation. C2i will be responsible for the AI-based analysis of data, recruitment of samples and various clinical trial activities.

On January 14, 2020 Boston Scientific Corporation (NYSE: BSX) generated sales, reported that based upon preliminary unaudited financial information, of approximately $2.90 billion during the fourth quarter of 2019 (Press release, Boston Scientific Nordic, JAN 14, 2020, View Source [SID1234553204]). This represents growth of approximately 13.4 percent on a reported basis, compared to the company’s guidance range of 13 to 15 percent; approximately 14.1 percent on an operational1 basis, compared to the company’s guidance range of 14 to 16 percent; and approximately 7.3 percent on an organic2 basis, compared to the company’s guidance range of 8 to 9 percent, all compared to the prior year period.

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For the full year 2019, the company generated sales, based upon preliminary unaudited financial information, of approximately $10.74 billion. This represents growth of approximately 9.3 percent on a reported basis, compared to the company’s guidance range of 9 to 9.5 percent; approximately 11.1 percent on an operational basis, compared to the company’s guidance range of 11 to 11.5 percent; and approximately 7.3 percent on an organic basis, compared to the company’s guidance of approximately 7.5 percent, all compared to the prior year period.

Preliminary net sales for the fourth quarter by business and region:

Sales growth rates that exclude the impact of foreign currency fluctuations and/or the impact of recent acquisitions and divestitures with significant sales are not prepared in accordance with U.S. GAAP.

While the company is still conducting financial closing procedures for the fourth quarter and full year, the company estimates that it will exceed its previously issued guidance for earnings of $0.22 to $0.25 for the fourth quarter and $0.72 to $0.75 per share for the full year 2019, on a GAAP per share basis, primarily due to a significant non-cash tax benefit arising from an intra-entity asset transfer of intellectual property completed in the fourth quarter of 2019. The company estimates adjusted earnings, excluding certain charges (credits), will be within its previously issued guidance range of $0.42 to $0.45 per share for the fourth quarter of 2019 and a range of $1.55 to $1.58 per share for the full year 2019.

All of the information in this press release is preliminary and subject to completion of year-end financial reporting processes, reviews and audit.

1. Operational revenue growth excludes the impact of foreign currency fluctuations.

2. Organic revenue growth excludes the impact of foreign currency fluctuations and sales from the recent acquisitions of NxThera, Inc., Claret Medical, Inc., Augmenix, Inc., Vertiflex, Inc. and BTG plc (BTG), each with no prior year comparable sales. Organic revenue growth also excludes the impact of the divestiture of our global embolic microspheres portfolio, a transaction entered into in connection with obtaining the antitrust clearances required to complete the BTG transaction.

3. We have three historical reportable segments comprised of Medical Surgical (MedSurg), Rhythm and Neuro, and Cardiovascular, which represent an aggregation of our operating segments that generate revenues from the sale of medical devices (Medical Devices). As part of our acquisition of BTG on August 19, 2019, we acquired an Interventional Medicine business, which is now included in our Peripheral Interventions operating segment’s 2019 revenues from August 19, 2019 through December 31, 2019.

4. As part of our acquisition of BTG on August 19, 2019, we acquired a specialty pharmaceuticals business (Specialty Pharmaceuticals). Subsequent to acquisition, Specialty Pharmaceuticals is now a stand-alone operating segment presented alongside our Medical Device reportable segments. Specialty Pharmaceuticals net sales are substantially U.S. based. Our chief operating decision maker (CODM) reviews financial information of our globally managed Specialty Pharmaceuticals operating segment at the worldwide level without further disaggregation into regional results. As such, Specialty Pharmaceuticals net sales are presented globally, and our Medical Devices reportable segments regional net sales results do not include Specialty Pharmaceuticals.

J.P. Morgan Healthcare Conference on Tuesday, January 14, 2020
Also as previously announced, Boston Scientific will participate in the J.P. Morgan Healthcare Conference today in San Francisco. Mike Mahoney, chairman and chief executive officer, will present at approximately 8:00 a.m. PST. At 8:30 a.m. PST, Mike will be joined by Dan Brennan, executive vice president and chief financial officer, Dr. Ian Meredith, executive vice president and global chief medical officer, and Susie Lisa, vice president, Investor Relations, in a question-and-answer session with the host analyst and audience members.

A live webcast of the presentation and question-and-answer session will be available on the Investor Relations section of the Boston Scientific website at investors.bostonscientific.com. A replay of the webcast will be accessible at investors.bostonscientific.com beginning approximately one hour following the completion of the event.

Conference Call on Wednesday, February 5, 2020
As previously announced, Boston Scientific will webcast its conference call discussing financial results and business highlights for the fourth quarter and full year 2019 and provide first quarter and full year 2020 guidance on Wednesday, February 5, 2020 at 8:00 a.m. EST. A live webcast of the conference call will be available on the Investor Relations section of the website at investors.bostonscientific.com. A replay of the webcast will be archived and available at investors.bostonscientific.com beginning approximately one hour following the completion of the meeting.

On January 14, 2020 Caris Life Sciences, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, reported that The Preston Robert Tisch Brain Tumor Center at Duke University Hospital has become the 32nd member of its Precision Oncology Alliance (Press release, Caris Life Sciences, JAN 14, 2020, View Source [SID1234553203]). The Alliance is a collaborative network of leading cancer centers that demonstrates a commitment to precision medicine. These centers work together toward a common goal to advance tumor profiling and establish standards of care for molecular testing in oncology.

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The Preston Robert Tisch Brain Tumor Center was one of the first brain tumor research and clinical programs in the United States. Since then, it has advanced to become one of the best pediatric and adult neuro-oncology programs in the world—leading the way in comprehensive care that combines research breakthroughs, clinical trials and the newest therapies. The National Cancer Institute (NCI) has given the center the highest rating of "exceptional" for each of the last 15 years.

The mission of the Center is to provide hope and empower brain tumor patients with unparalleled care, research and education. The Center sees up to 900 new adult brain tumor patients and up to 75 new pediatric brain tumor patients per year from across the country and around the world.

"We are excited to welcome Preston Robert Tisch Brain Tumor Center into the Precision Oncology Alliance," said Brian J. Brille, Vice Chairman of Caris Life Sciences. "The Preston Robert Tisch Brain Tumor Center is globally recognized for its collaborative spirit and commitment to its patients and we expect this partnership with the Alliance members to help further progress the potential of molecular profiling."

Through the Precision Oncology Alliance – powered by Caris – The Preston Robert Tisch Brain Tumor Center will partner with other notable cancer centers and academic institutions to broaden patient access to precision cancer care, have early access to Caris’ Next Generation Profiling offerings, and establish evidence-based standards for tumor profiling and molecular testing in oncology. By leveraging the comprehensive genomic and proteomic tumor profiling services available through the Caris Molecular Intelligence platform, oncologists from the Center will be able to prioritize therapeutic options and determine which clinical trial opportunities may benefit their patients. Additionally, the Center’s researchers will partner with other Alliance members to contribute to and publish data and advance collaborative clinical trials.

"We are well known for pioneering cancer research that results in optimal, individualized treatment," said David Ashley, Ph.D., a Neuro-oncologist and Pediatric Neuro-oncologist at Duke Cancer Center. "We look forward to collaborating with Caris Life Sciences and the members of the Precision Oncology Alliance to fuel the next great discoveries in precision medicine."

The Precision Oncology Alliance comprises 32 academic, hospital and community-based cancer institutions, including ten NCI-designated Comprehensive Cancer Centers. The Alliance now includes over 1,350 physicians, spanning more than 400 locations, who provide services for over 280,000 people with cancer each year. Precision Oncology Alliance members also have access to Caris Pharmatech’s oncology trial network, which can help reduce the time it takes to identify and connect appropriate patients with novel targeted cancer therapies in clinical development.

On January 14, 2020 Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported its preliminary unaudited revenue for the fourth quarter and year ended December 31, 2019 (Press release, Nevro, JAN 14, 2020, View Source [SID1234553202]). In addition, the Company is providing its worldwide revenue guidance for the full year 2020.

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Fourth Quarter 2019
Preliminary unaudited fourth quarter 2019 worldwide revenue is expected to be $114.4 million, compared to $107.9 million in the fourth quarter in the prior year period. Preliminary unaudited fourth quarter 2019 U.S. revenue is expected to be $97.9 million, compared to $91.6 million in the prior year period. Preliminary unaudited fourth quarter 2019 international revenue is expected to be $16.5 million, compared to $16.3 million in the prior year period. Fourth quarter U.S. trial procedure growth was 17% and permanent implant procedure growth was 20%.

Full Year 2019
Nevro’s preliminary unaudited full year 2019 worldwide revenue is expected to be $390.3 million, compared to $387.3 million in the prior year period. Preliminary unaudited full year U.S. revenue is expected to be $326.0 million, compared to $321.8 million in the prior year period. Preliminary unaudited full year international revenue is expected to be $64.3 million, compared to $65.5 million in the prior year period.

Worldwide Revenue Guidance for Full Year 2020
Nevro currently expects full year 2020 worldwide revenue to be in the range of $435 to $440 million. The Company plans to provide additional guidance metrics for 2020 when it reports its fourth quarter and full year 2019 results in February.

On January 14, 2020 Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, reported that its Target Selector assays are now available to physicians in order to evaluate the cerebrospinal fluid (CSF) of their patients for the presence of circulating tumor cells (CTCs) and biomarkers for patients with breast or lung cancer suspected of brain or central nervous system (CNS) metastases (Press release, Biocept, JAN 14, 2020, View Source [SID1234553201]). The presence of tumor cells in CSF may be an indicator of brain metastases, which occurs when cancer has spread into the CNS. Up to 30% and 36% of patients diagnosed with breast and lung cancer, respectively, will develop brain metastases.

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"Testing the CSF for cancer biomarkers in patients suspected to have brain metastases can be important, as the rapid confirmation and characterization of CNS involvement enables appropriate treatment selection in a timely manner," stated Santosh Kesari, MD, PhD, Chair and Professor, Department of Translational Neurosciences and Neurotherapeutics, Director of Neuro-oncology at the Pacific Neuroscience Institute and John Wayne Cancer Institute. "Liquid biopsy tests offer the ability to analyze an additional specimen type, beyond blood, to help physicians identify biomarkers and hence inform clinical decision making."

"We are very pleased to make our Target Selector platform available for testing CSF, as a more rapid identification of molecular alterations in brain metastases can aid physicians in choosing the best treatment options for their patients with breast or lung cancer," said Michael W. Nall, Biocept’s President and CEO. "Among the significant capabilities of our technology is its versatility, which enables applications in a variety of clinical situations and for use with multiple types of biofluids."

About CSF Testing

A medical procedure known as a spinal tap or lumbar puncture is typically done to collect CSF when cancer patients present with CNS symptoms, for example confusion or dementia. Over 200,000 of these procedures are performed annually in the U.S. Biocept’s Target Selector testing provides an alternative and potentially more accurate means compared to cytology to evaluate CSF. For more information about Biocept’s Target Selector testing, please contact Biocept Customer Services at 888.332.7729.