GENE ONLINE|News &
Opinion
Blog

2019-12-09| R&DTrials & Approvals

FoundationOne®CDx Approved as Companion Diagnostic for Novartis’ Piqray

by Rajaneesh K. Gopinath
Share To

FoundationOne®CDx is a comprehensive genomic profiling test that became the first FDA approved broad companion diagnostic for all solid tumors. Last week, the genomic biomarker assay bagged FDA approval for its 19th indication.

Genetic testing is increasingly becoming a prerequisite for patients who are on their way to a cancer diagnosis and treatment. In screening for cancer, standard methodologies such as immunohistochemistry, FISH, and PCR helped physicians only to look for a handful of previously known mutations but the advent of next-generation sequencing improved that number. However, comprehensive genomic profiling (CGP) is a test that examines all the different classes of cancer-relevant mutations taking the entire coding region of a gene into account. In an exclusive interview with GeneOnline, Dr. Nicolas Martin, International Scientific Lead at Roche Foundation Medicine had likened the CGP technology to switching on a ceiling light in a dark room as compared to the earlier methods which are akin to using hand torches.

FDA Approval for 19th Indication

FoundationOne®CDx has been FDA approved based on stringent analytical and clinical validations of more than 6,300 samples. As an acknowledgment of this quality, it had been approved as a companion diagnostic for 18 FDA-approved targeted therapies previously. On December 4th, the company announced its FDA approval as a companion diagnostic for Piqray® (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with HR+/HER2-, PIK3CA mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen. Piqray is the first and only treatment specifically for patients with this indication and was FDA approved last May. This is a result of an ongoing collaboration between Foundation Medicine and Novartis to develop companion diagnostics for the latter’s oncology portfolio.

“Foundation Medicine is proud to achieve another FDA approval for FoundationOne®CDx as a companion diagnostic for Piqray for the treatment of metastatic breast cancer with a PIK3CA mutation,” stated Brian Alexander, M.D., M.P.H. Foundation Medicine’s Chief Medical Officer. “The advancements we are seeing in the treatment of breast cancer underscore the importance of harnessing genomic insights to enable personalized medicine. Taking a comprehensive and validated approach to genomic testing is critical for patients with metastatic breast cancer to help physicians determine a treatment roadmap upfront that may include FDA-approved targeted therapies like Piqray.”

References

  1. https://www.foundationmedicine.com/press-releases/a9f8e620-9997-43e1-a5c9-94c79616f07f
©www.geneonline.com All rights reserved. Collaborate with us: [email protected]
Related Post
Topo-1 and FRα: Key Focus Areas and Major Collaborations in ADC Research – Part I
2024-07-23
STLI Webinar Series 1: Experts Discuss Regulatory Trends in Regenerative Medicine
2024-07-16
Foreseen Biotech Strikes $1.03B Deal with Ipsen for First-in-Class ADC
2024-07-12
LATEST
Topo-1 and FRα: Key Focus Areas and Major Collaborations in ADC Research – Part I
2024-07-23
Eli Lilly’s Tirzepatide Gets Approval in China for Weight Loss Management
2024-07-22
Roche Reports Positive Clinical Trial Results for Two Diabetes-Related Eye Disease Therapies
2024-07-19
7th Person in History Possibly Cured From HIV After Stem Cell Transplant for Acute Myeloid Leukemia
2024-07-19
Large RCT Finds Time-Lapse Imaging for Embryo Selection in IVF Does Not Improve Live Birth Rates
2024-07-19
Assessment of Supply Chain Risk Key to Improving Medicine Access
2024-07-18
SK Biopharma and Full-Life Sign US$571.5 Million Deal for Innovative Radiopharmaceutical FL-091
2024-07-18
EVENT
Scroll to Top