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New Products

Tempus Unveils Tempus O, a Platform to Structure and Annotate Clinical Data at Scale
Nasdaq – Dec 7, 2017
Tempus announced the launch of Tempus O, a groundbreaking system that collects, structures and analyzes clinical data from electronic medical records, research databases, images, and physician notes to generate therapeutic insights.

SYGNIS AG Launches TruePrime(TM) Apoptotic Cell Free DNA Amplification Kit for the Liquid Biopsy Markets
Technology Networks – Dec 6, 2017
SYGNIS AG the Group which includes Expedeon Holdings, Innova Biosciences, and C.B.S. Scientific Company, has announced the launch of its TruePrime™ apoptotic cell free DNA amplification kit, under the Expedeon brand.

Cancer Institute Funds Blood Test for Early Pancreatic Cancer Detection
Healio – Dec 12, 2017
The National Cancer Institute’s Pancreatic Cancer Detection Consortium has awarded a $5.13 million grant to researchers from Baylor Scott & White Research Institute and the Translational Genomics Research Institute, which are developing a blood test for early detection of pancreatic cancer.

Regulatory and Reimbursement Updates

FDA Approves Foundation Medicines FoundationOne CDx, the First Pan-Tumor Comprehensive Genomic Profiling Assay Incorporating a Broad Range of Companion Diagnostics
Miltech PR Distribution – Dec 4, 2017
Roche announced today that the US Food and Drug Administration (FDA) has approved FoundationOne CDx™, Foundation Medicine’s comprehensive companion diagnostic assay for personalised oncology care.

CMS Issues Proposed National Coverage Determination of NGS IVDs Including Thermo Fisher Scientific’s Oncomine Dx Target Test
PR Newswire – Dec 7, 2017
The Centers for Medicare & Medicaid Services (CMS) has proposed coverage for the Oncomine Dx Target Test as part of a national coverage determination (NCD) for next-generation sequencing (NGS) in vitro diagnostic (IVD) tests. Once implemented, the NCD would provide Medicare beneficiaries with reimbursable testing using Thermo Fisher Scientific’s multi-biomarker non-small cell lung cancer (NSCLC) diagnostic.

Key Partnerships and Collaborations

UCSF, NantHealth Team on Metastatic Breast Cancer Study
Genome Web – Dec 4, 2017
Researchers at the University of California, San Francisco, will use NantHealth’s GPS Cancer™ panomic molecular analysis test to explore the molecular basis of patients with metastatic or recurrent breast cancer.

Tempus’ Latest Take on Cancer is Through Immunotherapy
Wings Journal – Dec 4, 2017
Tempus paired up with Georgetown Lombardi Comprehensive Cancer Center and John Theurer Cancer Center in a new research collaboration that will focus on identifying cancer patients that respond favorably to what is regarded the next generation of cancer care, namely immunotherapy treatment. This collaboration is considered to be part of the value-based care trend that relies on precise classification if illness and smarter use of data to advance clinical outcomes and reduce cancer-care costs.

NeoGenomics Joins Thermo Fisher Scientific’s Companion Diagnostic Center of Excellence Program with the Launch of Oncomine Dx Target Test
Markets Insider – Dec 5, 2017
NeoGenomics, Inc. has signed an agreement with Thermo Fisher Scientific to join the Next-Generation Sequencing Companion Dx Center of Excellence Program (COEP).

Eric Lefkofsky’s Tempus Health Tech Teams Up with CancerLinQ
Hi-Tech Chronicle – Dec 27, 2017
By partnering with Precision Health AI, a New York-based startup in artificial intelligence, and obtaining access to CancerLinQ, it recently took a step closer to that goal. CancerLinQ is a database of treatment results on about 600,000 patients, and it is developed by the American Society of Clinical Oncology, the top organization of cancer doctors.

Celsee, Zomedica Partner on Veterinary Liquid Biopsy Dx
Genome Web – Dec 21, 2017
Celsee, a developer of circulating tumor cell isolation technology, has partnered with Zomedica, a veterinary pharmaceutical and diagnostics company, to develop and commercialize Celsee’s liquid biopsy platform for use by veterinarians as a cancer diagnostic.

Research and Clinical Validation Updates

Comparison of miRNA Quantitation by Nanostring in Serum and Plasma Samples
PLOS ONE – Dec 6, 2017
We analyzed circulating miRNA in serum and plasma samples obtained concurrently from 28 patients, using a Nanostring quantitative assay platform. The diversity of miRNA detected was greater in plasma than in serum samples.

ITUS Will Present Data on Early Cancer Detection Technology at ASCO-SITC Symposium
PR Newswire – Dec 6, 2017
ITUS Corporation announced that its abstract titled, “The coupling of MDSCs with a computational analytic method to detect solid tumors,” was accepted for presentation at the 2nd annual American Society of Clinical Oncology-Society for Immunotherapy of Cancer (ASCO-SITC) Clinical Immuno-oncology Symposium in San Francisco, CA. Myeloid-derived suppressor cells, or MDSCs, are a key group of white blood cells that form the foundation for ITUS’ liquid biopsy technology.

OncoCyte Presents Positive Data from its Liquid Biopsy Breast Cancer Diagnostic Test at the San Antonio Breast Cancer Symposium
Nasdaq – Dec 7, 2017
OncoCyte Corporation presented positive data from its most recent breast cancer diagnostic test study at the 2017 San Antonio Breast Cancer Symposium (SABCS). The data were presented by Philip McQuary, Ph.D., Director of Product Development at OncoCyte.

Commercialization Milestones

First U.S. Patent Issued for Biocept’s Target Selector Oncogene Mutation Enrichment and Detection Liquid Biopsy ctDNA Platform
PR Newswire – Dec 5, 2017
Biocept, Inc. announced the issuance of U.S. Patent No. 9,834,817, entitled METHODS FOR DETECTING NUCLEIC ACID SEQUENCE VARIANTS. The patent is core to Biocept’s Target Selector™ assays for ctDNA analysis using real-time PCR, Sanger sequencing and next generation sequencing (NGS).

Anpac Bio Surpasses 100 Case Milestone Detecting Disease in Patients Deemed “Cancer Free’ by Traditional Screening
Markets Insider – Dec 27, 2017
Dr. Chris Yu, Chief Executive Officer of international life sciences corporation Anpac Bio-Medical Science Company, announced surpassing a new, international record. Anpac Bio’s breakthrough, proprietary, “Cancer Differentiation Analysis” (CDA) liquid biopsy technology identified the earliest cancer and pre-cancerous disease signals in over 100 individuals previously deemed “cancer free” by other traditional, standard-of-care screening tests.

Clearbridge BioMedics Expands Availability of the ClearCell(R) FX1 System to EMEA and APAC Regions
PR Newswire – Dec 12, 2017
Clearbridge BioMedics announced that its ClearCell® FX1 System is now broadly available in EMEA and APAC regions to complement its direct availability in the US and existing distribution channels. This was made possible through partnerships with twelve new distributors. The ClearCell® FX1 System is an automated liquid biopsy system for the enrichment of circulating tumor cells from blood.

Hiring & HR Activity

Roche’s Jennifer Cook Appointed CEO of Grail
xconomy – Dec 14, 2017
Grail has appointed Jennifer Cook to serve as CEO of the cancer screening company. Cook comes to Menlo Park, CA-based Grail from Roche, where she is head of clinical operations in product development for the company’s pharmaceuticals division.


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