As next-generation sequencing (NGS) reaches the clinical laboratory, a new analysis by Kalorama Information (New York, NY, USA) finds that small reference laboratories as well as over 50 companies now offer sequencing-based testing through their own CLIA-certified laboratories, some of which offer a wide range of tests.

“These firms and reference laboratories offer next-gen sequencing that they perform and charge for as a service,” said Bruce Carlson, Kalorama publisher. [Tests for presence of or] “Increased risk for breast and colon cancers, childhood epilepsy, renal disorders, prenatal tests, and many others are available now.” The new report, “Next Generation Sequencing Markets 2015,” features detailed information on top market competitors.

The large amounts of sequence date generated by NGS research can be valuable for trying to answer many questions regarding the genome and disease, but initially cannot be used by clinicians in making treatment decisions. Kalorama notes that diagnostic companies have realized the importance of more targeted approaches focusing on gene mutations with known clinical utility. In addition, sequencing platforms have traditionally been expensive, and using these instruments to test samples has been complex – with requirements for sample preparation, sequencing, and results analysis and interpretation. This has made it difficult to follow the traditional in vitro diagnostic (IVD) approach of developing kits that can be sold to clinical laboratories that would perform the tests. As a result, diagnostic sequencing has generally been performed by clinical laboratories or by companies that establish their own CLIA-certified laboratory.

Kalorama’s report provides details on NGS test offerings of each company as well as detailed tables indicating activities of competitors. The report breaks out system, consumable, and service segments, and provides information on brand ownership and regional installed base of sequencers.