CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc., a pioneer successful molecular profiling for cancer, contiguous announced that the U.S. Food and Drug Administration (FDA) has approved its FoundationOne®Liquid CDx arsenic a companion diagnostic to place patients with non-small compartment lung crab (NSCLC) whose tumors person epidermal maturation origin receptor (EGFR) exon 19 deletions oregon exon 21 L858R substitutions and are due for attraction with a radical of existent and aboriginal EGFR tyrosine kinase inhibitors (TKI) approved by the FDA for this indication. Group approvals are granted erstwhile grounds is capable to reason that a companion diagnostic is due for usage with a circumstantial radical of therapies, alternatively than circumstantial products.1
Specific segments of the DNA molecule, called exons, incorporate accusation that helps to codification proteins. EGFR mutations seen successful NSCLC patients are owed to mutations wrong 2 circumstantial exons—deletions successful exon 19 and substitutions successful exon 21.2 Since EGFR mutations are the 2nd astir communal drivers of tumor maturation successful NSCLC patients, the quality to pinpoint 2 of the largest catalysts of crab maturation successful these patients provides oncologists with much penetration for their targeted attraction planning.
“For NSCLC patients whose tumors person EGFR exon 19 deletions oregon exon 21 substitutions, this support opens caller entree avenues for targeted attraction options,” says Mia Levy, M.D., Ph.D., main aesculapian serviceman astatine Foundation Medicine. “Following 3 caller radical companion diagnostic approvals for Foundation Medicine’s tissue-based test, FoundationOne®CDx, this archetypal radical support for FoundationOne Liquid CDx builds upon the momentum for much businesslike and innovative regulatory approaches to the companion diagnostic support process. These efforts assistance to support the high-quality standards and rigor of the process, portion streamlining the attack to processing TKIs to get these treatments to patients faster.”
As a companion diagnostic for each therapies successful this radical targeting these mutations successful NSCLC, FoundationOne Liquid CDx offers oncologists flexibility erstwhile selecting the close therapy for their patients and ensures each FDA approved attraction options are considered wrong this radical of therapies.
The existent therapies for which FoundationOne Liquid CDx is simply a companion diagnostic nether the radical approvals are Tarceva (erlotinib), Tagrisso (osimertinib) and Iressa (gefitinib). Moving forward, FoundationOne Liquid CDx volition automatically go a companion diagnostic for aboriginal TKIs wrong this radical for NSCLC that are approved by the FDA.
About FoundationOne Liquid CDx
FoundationOne Liquid CDx is simply a qualitative adjacent procreation sequencing based successful vitro diagnostic trial for medicine usage lone that uses targeted precocious throughput hybridization-based seizure exertion to analyse 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral full humor of precocious crab patients. The trial is FDA-approved to study abbreviated variants successful implicit 300 genes and is simply a companion diagnostic to place patients who whitethorn payment from attraction with circumstantial therapies (listed successful Table 1 of the Intended Use) successful accordance with the approved therapeutic merchandise labeling. Additional genomic findings whitethorn beryllium reported and are not prescriptive oregon conclusive for labeled usage of immoderate circumstantial therapeutic product. Use of the trial does not warrant a diligent volition beryllium matched to a treatment. A antagonistic effect does not regularisation retired the beingness of an alteration. Patients who are antagonistic for companion diagnostic mutations should beryllium reflexed to tumor insubstantial investigating and mutation presumption confirmed utilizing an FDA-approved tumor insubstantial test, if feasible. For the implicit label, including companion diagnostic indications and implicit hazard information, delight sojourn www.F1LCDxLabel.com.
About FoundationOne CDx
FoundationOne CDx is simply a next-generation sequencing based successful vitro diagnostic instrumentality for detection of substitutions, insertion and deletion alterations (indels), and transcript fig alterations (CNAs) successful 324 genes and prime cistron rearrangements, arsenic good arsenic genomic signatures including microsatellite instability (MSI) and tumor mutational load (TMB) utilizing DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor insubstantial specimens. FoundationOne CDx is for medicine usage lone and is intended arsenic a companion diagnostic to place patients who whitethorn payment from attraction with definite targeted therapies successful accordance with their approved therapeutic merchandise labeling. Additionally, FoundationOne CDx is intended to supply tumor mutation profiling to beryllium utilized by qualified wellness attraction professionals successful accordance with nonrecreational guidelines successful oncology for patients with coagulated malignant neoplasms. Use of the trial does not warrant a diligent volition beryllium matched to a treatment. A antagonistic effect does not regularisation retired the beingness of an alteration. Some patients whitethorn necessitate a biopsy. For a afloat database of targeted therapies for which FoundationOne CDx is indicated arsenic a companion diagnostic, delight sojourn www.f1cdxlabel.com.
About Foundation Medicine: Your Essential Partner successful Cancer Care
Foundation Medicine is simply a pioneer successful molecular profiling for cancer, moving to signifier the aboriginal of objective attraction and research. We collaborate with a wide scope of partners crossed the crab assemblage and strive to acceptable the modular for quality, technological excellence, and regulatory leadership. Our heavy knowing of crab biology helps physicians marque informed attraction decisions for their patients and empowers researchers to make caller medicines. Every day, we are driven to assistance our partners find answers and instrumentality action, enabling much radical astir the satellite to payment from precision crab care. For much information, delight sojourn america connected www.FoundationMedicine.com and travel america connected Twitter and LinkedIn.
Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.
1 U.S. Food and Drug Administration. “Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products.” https://www.fda.gov/media/120340/download
2 Peter T. Harrison, Simon Vyse, Paul H. Huang. “Rare epidermal maturation origin receptor (EGFR) mutations successful non-small compartment lung cancer.” https://www.sciencedirect.com/science/article/pii/S1044579X19303025
Source: Foundation Medicine
English (US)