Chinese Market Comes to the Fore in Cancer Diagnostics

Chinese Market Comes to the Fore in Cancer Diagnostics

In 2016, China is a clear market development priority for the IVD industry in the areas of cancer screening tests, companion diagnostics, and sequencing-based cancer assays.


Moonshot Initiative Promotes Next Generation of Molecular Cancer Diagnostics

Moonshot Initiative Promotes Next Generation of Molecular Cancer Diagnostics

Cancer is the common thread through several fronts of U.S. regulatory development, whether approval of targeted therapeutics; coverage and reimbursement decisions for advanced diagnostic laboratory tests (ADLTs); or expansion of FDA regulatory oversight over laboratory developed tests (LDTs). The disease is also a healthcare and research and development (R&D) focus of the Obama administration. Just as instrumental as cancer’s high societal burden and aging-driven rise in incidence, the proliferation of its genetic analytes and druggable targets has caught the attention of regulators.


IBM Watson Health and Quest Diagnostics’ Bid to Advance Clinical Sequencing Informatics

IBM Watson Health and Quest Diagnostics’ Bid to Advance Clinical Sequencing Informatics

With next-generation sequencing (NGS), research scientists and clinicians are provided abundant raw data, but also too often deficient analytics software also known as informatics. Vendor-specific sequencing informatics software has limited access to third-party research discoveries in genomics. Sequencing analytics already in the clinical field may struggle to remain current with quickly evolving understanding of the genomic, epigenomic and transcriptomic underpinnings in cancer.


Ariosa Matches Sequenom-Illumina with NIPT LDT Licensing Move

Following the agreement between Sequenom and Illumina earlier this year allowing the latter to license pooled non-invasive prenatal testing (NIPT) IP to third-party labs worldwide, Roche Diagnostics’ Ariosa Diagnostics announced this week that it would grant licenses to labs for its own technology relating to NIPT. The three major players in prenatal testing operate their own labs to perform NIPT services on sent-out samples, but have encouraged outside labs to adopt their technologies in order ...


Carrier, Prenatal and Pediatric Genetic Testing Still a Big Draw for Investors and Labs

Carrier, Prenatal and Pediatric Genetic Testing Still a Big Draw for Investors and Labs

Genetic testing for inherited diseases has been a volatile industry space in recent years headlined by Myriad Genetics’ hold over BRCA testing and the subsequent opening of that market to competition with a 2013 Supreme Court ruling. Outside of testing for patient testing for oncology risk, a significant component of genetic testing is reproductive health-oriented testing for carrier genes and prenatal conditions. Atop the high-growth market for non-invasive prenatal testing (NIPT) are Sequenom ...


Next-Generation Sequencing Stays Ahead of the Market Curve

Next-Generation Sequencing Stays Ahead of the Market Curve

The impact of genetic sequencing on life sciences research, biotechnology and medicine is unprecedented. In 25 years, genomic knowledge has been built on a staggering scale: first enabled with the innovation and commercialization of Sanger sequencing, pieced together in coordinated efforts between various institutes, and then tremendously accelerated with the introduction of higher-throughput next-generation sequencing (NGS) technologies. Sequencing remains a dynamic space that has escaped marke...