NantHealth’s TMB Assay Wins FDA Authorization

Omics Core is the first FDA authorized custom-targeted, whole-exome sequencing platform to report both overall TMB in tumor specimens from 19,396 protein-coding genes (whole exome) and somatic alterations in 468 cancer-relevant genes.
Biotechnology, conceptual illustration

UVM Health Taps LunaPBC, Invitae on Genomic Testing Pilot Project

The pilot project will provide information for 147 genes that are well-established indicators of increased risk for certain diseases for which clinical treatment guidelines are established.

Many Doctors Not Discussing Genomic Test Costs with Patients

As the use of genomic testing increases, many doctors are failing to discuss the costs of these tests with their patients, leaving them at risk of unexpected medical bills.

Testing Panel for Immune Response Following Organ Transplant

NanoString Technologies has announced the launch of nCounter Human Organ Transplant, a gene expression panel for researchers to evaluate the human immune response following organ transplantation.

Invitae to Acquire Clear Genetics for $50M, Adding Chatbots for Genetic Counseling

Through the acquisition, Invitae will gain access to Clear Genetics' chatbot named Gia, short for “Genetic Information Assistant,” which is designed to offer patients guidance for understanding test results.
Biocept intends to become Thermo Fisher Scientific’s “Center of Excellence” for oncology-focused liquid biopsy efforts as part of a commercial collaboration by the companies. [© AlexRaths/iStock]

Lexent, Illumina Enter Partnership for Cancer Monitoring Liquid Biopsy Kits

Confera Dx is currently in development with the intention to be made available next year as a laboratory-developed test performed by Lexent in a CLIA-certified laboratory with the intention of developing a distributed in vitro diagnostic at a later date. 
Transmission electron micrograph of AIDS, HIV-1

Vela Diagnostics Gets FDA Approval for HIV-1 NGS Assay

The Sentosa SQ HIV-1 Genotyping Assay uses the plasma of patients infected with human immunodeficiency virus-1 and is the first and only HIV-1 genotyping NGS assay currently available on the market to receive FDA marketing authorization.
Owlstone Medical will partner with Renji Hospital in Shanghai to conduct a clinical trial assessing the company's Breath Biopsy diagnostic breathalyzer platform in early detection of lung cancer

Owlstone Medical, Thermo Fisher Forge Breath Biopsy Technology Collaboration

The collaboration will integrate Thermo Fisher’s Orbitrap gas chromatography mass spectrometry (GC-MS) instrumentation into Owlstone’s breath biopsy platform to conduct metabolomics studies for unique biomarkers.

PredictImmune Partners with Foundation on Study to Validate IBD Test

The test stratifies patients based on their risk of subsequently experiencing a severe disease course, which is characterized by the requirement for multiple escalations in treatment due to frequently relapsing or chronically active disease.

Treading with Caution: PGx Test Developers Pursue Dialogue as FDA Maintains Enforcement Stance

Developers of pharmacogenetic tests cheered in August when United Healthcare (UHC) concluded in a policy statement effective October 1, that “the use of pharmacogenetic...
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