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    Clear Labs Expands Pilot Ahead of Food Testing Platform Launch

    Article: In-Depth—in Sequencing

    Pilot participants have access to a version of Clear Labs' sequencing and analysis platform that is designed for high-volume food safety and quality testing.

    St. Jude Opens Its Pediatric Cancer Sequencing Data to Researchers Worldwide

    Article: In-Depth—in Informatics

    St. Jude Cloud, powered by DNAnexus and Microsoft, offers free access to thousands of WGS records plus cloud-based visualization and computational tools.

    A private payor survey by ClearView Healthcare Partners found that medical directors viewed CMS's decision with caution; half had no plans to align commercial plan coverage.

    Introducing the Interstitium

    Blog Post—in The Scan

    In a new study in Scientific Reports, researchers have classified fluid-filled spaces in connective tissues all over the body as a new organ called the interstitium.

    Science Frenemies

    Blog Post—in The Scan

    Can genomics help archeologists study the past, Nature News asks, or is it getting in their way of understanding ancient cultures?

    CMS Final Coverage Policy for NGS Cancer Panels Eases Some Lab Industry Concerns

    Article: In-Depth—in Sequencing

    The policy states that lab tests without FDA's blessing may pursue local coverage via Medicare contractors, but national coverage requires premarket approval or clearance.

    TriCore Considering Broader Launch of 16S Metagenomic Assay for Bacterial Dx

    Article: In-Depth—in Infectious Disease

    The firm's assay is designed to detect the relative abundance of bacteria species in a patient's sample, allowing doctors to improve long-term inpatient care decisions.

    CMS-Proposed Coverage of NGS Cancer Tests Could Lead to Off-Label Scripts, Oncologists Worry

    Article: In-Depth—in Molecular Diagnostics

    A perspective that hasn't gotten as much attention is that the CMS draft coverage decision could be bad for patients by increasing off-label drug use based on the results of NGS panels.

    Executives at two commercial payors said they'd follow CMS' lead when it comes to patients covered under Medicare but beyond that their support for the agency's policy is less clear. 

    NIPT Commentary Raises Physician Conflict as Factor in Average-Risk Adoption

    Article: In-Depth—in Molecular Diagnostics

    Adam Wolfberg argued that while corporate conflicts are widely discussed, physicians also have financial conflicts that can bias them against new technology.

    Some industry players are accusing CMS of advancing backdoor LDT regulation by proposing to cover NGS tests with FDA approval/clearance, except in a limited setting.

    Celmatix Plans to Expand Next Year Following New Funding, Test Approval From NY State

    Article: In-Depth—in Reproductive Health

    The firm recently won $4.5 million as well as approval for its Fertilome test from New York state, though some have questioned the test's clinical utility.

    In Stanford Survey, Majority of Genetics Professionals Supports Human Gene Editing

    Article: Breaking News—in Policy & Legislation

    According to survey results presented at ASHG, most genetics experts support somatic and germline gene editing, though few favor trait enhancement.

    CogenDx Uses Molecular Methods to ID 'Unusual Suspect' Pathogens in Wound Care

    Article: In-Depth—in Molecular Diagnostics

    The firm hopes its newly launched DxWound will improve pathogen detection in skin and soft tissue infections by including anaerobic and fungal microbes in its reports.

    A new set of papers reveals a range of gene expression influencers, identified using thousands of samples collected for the Genotype-Tissue Expression project.

    The government payor proposed rates that would reduce payment by $670 million, though CMS previously estimated a $390 million cut in 2018.

    Gutierrez Leaving FDA After Leading Dx Regulatory Efforts During Precision Medicine Revolution

    Article: Breaking News—in Molecular Diagnostics

    His time at OIVD was one of breakneck advancement in molecular diagnostics, to which the agency responded with regulatory action and efforts to reduce regulatory burden.

    Counsyl, Natera at Odds Over Simulation Study of NIPT Performance at Low Fetal Fraction

    Article: In-Depth—in Molecular Diagnostics

    Counsyl believes its data is robust, while Natera has called the methodology and conclusions "gratuitously wrong." Both published opposing response letters this week.

    ETH Zurich Team Develops Algorithm for DIA-Based PTM Analysis

    Article: In-Depth—in Proteomics & Protein Research

    The method will allow DIA-based studies of protein PTMs similar to what has been possible using conventional data-dependent acquisition mass spec approaches.

    'Quality Versus Quantity'

    Blog Post—in The Scan

    According to Nature News, researchers are moving toward measuring biodiversity by the quality of functional variants rather than just the quantity of species.


Researchers have sequenced the northern white rhinoceros to gauge whether it could be brought back from the edge of extinction, the New York Times reports.

Bavaria expands its forensic genetic analyses to include DNA phenotyping, raising discrimination concerns.

Tufts University researchers found a role for miRNA in transmitting stress between generations, the Economist reports.

In Science this week: gut microbiome influences liver cancer growth, spread; and more.