Daniel Malarek, Chief Executive Officer at Foundation Medicine, shared a post on LinkedIn:
“Excited to share more incredible progress from the Foundation Medicine team. The US FDA has approved our first companion diagnostic indication to support pediatric patients.
Our high-quality tissue-based biomarker test can help healthcare providers connect their pediatric patients and families with a targeted therapy for those with relapsed or refractory pediatric-low grade glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. Our test is the first and only companion diagnostic for this therapy.
Thank you to the cross-functional team at Foundation Medicine for continuing to advance our mission of transforming cancer care. This approval adds to our legacy of developing high-quality diagnostic tests to identify the genomic mutations driving a patient’s tumor and match a patient to the most effective treatment options.
Read more here.”