FDA Approves FoundationOne CDx as Companion Diagnostic for Melanoma


FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements.

The FDA has approved FoundationOne CDx (Foundation Medicine) to be used as a companion diagnostic for 2 groups of current and future FDA-approved therapeutics in melanoma.

This will include BRAF inhibitor monotherapies targeting BRAFV600E and BRAF/MEK inhibitor combination therapies targeting BRAFV600E or V600K mutations. The approval makes FoundationOne CDx the only comprehensive genomic profiling test approved as a companion diagnostic across 2 groups of targeted therapies.1

“As the first group therapy approval for any comprehensive genomic profiling test, this milestone reinforces our dedication to pioneering advances that expand the power of genomic testing in cancer care,” Mia Levy, MD, PhD, chief medical officer at Foundation Medicine, said in a statement. “This approval will allow oncologists to uncover all possible FDA-approved treatment options for these indications through just one test, providing more insights for physicians and patients, more efficiently than ever before.”

According to the FDA, a companion diagnostic is a device that can be in vitro diagnostic devices to provide importation about a therapeutic product.2

FoundationOne CDx is a next-generation sequencing-based in vitro diagnostic device for detection, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements.

It is also used as a genomic signature including microsatellite instability and tumor mutational burden using DNA isolation from formalin-fixes. Paraffin-embedded tumor tissue specimens.

FoundationOne CDx is for prescription use only, and to help identify individuals who may benefit from treatment with certain therapies. It is also intended to provide a tumor mutation formula that could be used by health care professionals in accordance with professional guidelines in oncology for individuals with solid malignant neoplasms.

According to the Skin Cancer Foundation, melanoma is a serious form of skin cancer that can be dangerous because of its ability to rapidly spread to other organs.3 That makes early detection highly important for those with skin cancer.

BRAF mutations are also the most common type of mutation in melanoma with approximately half of all melanoma cases carrying this mutation, according to a study published in the Journal of Translational Medicine.4

The companion diagnostic can offer oncologists flexibility when selecting the right therapy for individuals with melanoma and ensures all treatment options are considered.

FoundationOne CDx is a companion diagnostic for Braftovi/Mektovi (Pfizer) and dabrafenib and trametinib combination (Tafinlar and Mekinist, Novartis).

This will automatically become a companion diagnostic for future BRAF inhibitors approved by the FDA under these groups, according to a press release.1


  1. FoundationOne®CDx receives FDA approval as a companion diagnostic for BRAF inhibitor Therapeutics in melanoma. Businesswire. News release. December 8, 2021. Accessed December 9, 2021. https://www.businesswire.com/news/home/20211208005268/en
  2. List of cleared or approved companion diagnostic devices (in vitro and imaging tools). FDA. Website. https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools
  3. Melanoma overview: a dangerous skin cancer. Skin Cancer Foundation. Website. https://www.skincancer.org/skin-cancer-information/melanoma/
  4. Ascierto, P A, Kirkwood J M, Grob, J, et al. The role of BRAF V600 mutations in melanoma. Journal of Translational Medicine. 2021;10:85. doi:10.1186/1479-5876-10-85.
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