Already in clinical validation with multiple world-leading cancer institutes, Signatera offers a novel personalized approach to cancer detection in plasma.
The technology analyses whole-exome sequencing data from a patient's tumor sample in order to custom design individual-specific assays, targeting 16 or more tumor signatures, mutations known to be present in the tumor tissue, enabling high sensitivity and specificity for ctDNA detection and monitoring.
By targeting 16 or more patient-specific mutations, Signatera has a higher probability of detecting ctDNA targets in plasma, compared with a generic-panel approach.
It detects variant allele frequencies down to 0.01%, and is optimised to achieve high specificity by requiring detection of multiple mutations for a ctDNA-positive call, leading to fewer false positives.
An early version of Signatera identified 43% more ctDNA-positive early-stage lung cancer cases than a generic lung cancer panel and demonstrated its potential to detect residual disease, measure treatment response, and identify recurrence up to 11 months earlier than the standard of care.
Natera is a genetic testing company that develops and commercializes non-invasive methods for analysing DNA.
It operates a CAP-accredited laboratory and offers proprietary genetic testing services primarily to OB/GYN physicians and fertility centers, as well as to genetic laboratories through its cloud-based Constellation software platform.
The company is also applying its unique technologies to develop non-invasive screening and diagnostic tools for earlier detection and improved treatment of cancer. These tests have not yet been cleared or approved by the FDA.
Apotex launches Teriparatide Injection in US
Teva Pharmaceuticals secures FDA approval for generic Forteo (teriparatide injection)
Upsher-Smith Laboratories introduces Pitavastatin Tablets
Par Pharmaceutical starts shipping colchicine 0.6mg capsules
Padagis launces Brinzolamide Ophthalmic Suspension with CGT exclusivity
Novartis completes Sandoz Spin-off
Novartis completes Sandoz spin-off, focusing on innovative medicines
Sanofi and Teva collaborate on innovative IBD treatment
Hikma marks KLOXXADO two-year anniversary by surpassing 375,000 doses donated in the US
STADA seeks full approval for Kinpeygo in IgA nephropathy from UK MHRA
Azurity Pharmaceuticals completes Slayback Pharma acquisition
Sandoz secures European approval for Tyruko biosimilar in MS treatment
Senores Pharmaceuticals introduces Nicardipine Hydrochloride Capsules USP, 20mg and 30mg in US
Lupin collaborates with Mark Cuban Cost Plus Drug Company and COPD foundation
Certara Simcyp receives FDA grants for advanced pharmacokinetic modelling