Foundation Medicine Submits IPO Prospectus Following FDA Approval of FoundationOne CDx, the First NGS-Based Pan-Cancer Companion Diagnostic

Beijing Time 2017Year12Month1Day,FDAOfficially approved.Foundation One CDx（F1CDx) marketing application. This isFDAThe first approved based onNGSIn Vitro Diagnostics(IVD) Multi-cancer companion diagnostic genetic testing platform.

Concurrently with the FDA’s approval of the product, the Centers for Medicare & Medicaid Services (CMS) issued national coverage determinations for F1CDx and other similar NGS/IVD products, defining the scope of insured beneficiaries with advanced-stage cancer (i.e., recurrent, metastatic, or Stage IV cancer).

CMS spokesperson Seema Verma stated, “Through collaborative efforts and parallel review by the FDA and CMS, we have accelerated the efficiency and speed of certifying novel diagnostic technologies, enabling physicians to provide patients with high-quality medical care more effectively and promptly, while allowing patients to benefit from improved clinical outcomes through these cutting-edge testing technologies.”

It is understood that F1CDx covers solid tumors associated with 24 genes and two genomic markers. Compared with the 510(k)-cleared 468-gene assay from Memorial Sloan Kettering Cancer Center, approved by the FDA in November, F1CDx represents the first breakthrough multi-gene, multi-cancer companion diagnostic in the field of next-generation sequencing (NGS).

This platform can detect gene mutation information in solid tumors and play an auxiliary role in cancer diagnosis and treatment. In addition, F1CDx can also be used for drug screening, helping patients with non-small cell lung cancer, melanoma, breast cancer, colorectal cancer or ovarian cancer receive precise treatment from FDA-approved drugs, providing assistance to patients throughout the entire process of diagnosis and treatment.

Compared with other FDA-approved diagnostic technologies or drugs, F1CDx offers unparalleled coverage. This product provides clinicians with a broader range of testing methods, significantly aiding in the clinical diagnosis and treatment of cancer patients. Furthermore, based on personalized test results, F1CDx assists clinicians in selecting the optimal therapy from among 15 different FDA-approved targeted treatment regimens for various solid tumors. It delivers comprehensive reports to patients and healthcare professionals, thereby avoiding the need for repeated biopsies.

This platform can detect multiple FDA-approved genetic mutations associated with more than one type of solid tumor.

In other words, this platform has transcended the “one drug, one test” model. This is perhaps the most significant implication of the F1CDx approval, marking a major step forward in transitioning tumor genetic testing from the laboratory to clinical practice.

The developer behind F1CDx is Foundation Medicine, a renowned U.S. oncology genomic testing company. The company’s cancer whole-genome sequencing technology gained fame through Steve Jobs, who was the first high-profile individual to use its services.

The company was founded in April 2010 and is headquartered in Cambridge, Massachusetts. Eric Lander, Director of the Broad Institute in Cambridge, was a leading figure in the Human Genome Project and one of the founders of Foundation Medicine, rightly earning him the title of “a pioneer at the forefront of genomic research.”

Foundation Medicine raised a total of $251 million in investment prior to its IPO. The company boasts many prominent investors, including Russian billionaire Yuri Milner and Evan Jones, a legendary figure in the U.S. diagnostics industry. In January 2013, Bill Gates invested $13.5 million in Foundation Medicine.

Source: Translational Medicine Network, Foundation Medicine Official Website