Foundation Testing

[TXteacher]

Just found this online. It was a financial presentation but also has a lot of technical info on foundation tests: A presentation by Troy Cox, Foundation Medicine's CEO, the firm reported preliminary fourth quarter revenues that were 70 percent higher than the fourth quarter the previous year. The revenues of $48.9 million were well above analysts' average estimate of $39.2 million.

As Cox noted, among the firm's most biggest accomplishments this past year was the FDA approval of its FoundationOne CDx (F1CDx), which concurrently received a preliminary national coverage determination from the US Centers for Medicare and Medicaid Services (CMS) under the parallel review program. The comment period for the NCD is ongoing and will close later this month, with a final decision expected to be issued in February.

F1CDx detects genetic variants in 324 genes known to drive cancer and looks for two genomic signatures — microsatellite instability (MSI) and tumor mutational burden (TMB) — in solid tumors of any type, which may help doctors with the clinical management of cancer patients according to professional guidelines. It is the companion diagnostic version of its FoundationOne test, which has been launched in 27 countries worldwide thus far.

The NCD covers five tumor types: ovarian, lung, breast, colorectal, and melanoma. But Cox said it will be an expandable NCD, and Foundations aim is to make the test a universal platform for CDx development that is "evergreen" in nature, frequently being updated. He added that one of the company's growth pillars is shaping the targeted and immunotherapy landscape with new and emerging biomarkers.

While Foundation Medicine expects F1CDx to see an increase in revenues after the NCD is finalized and as the year progresses, the price CMS will reimburse remains uncertain. According to JP Morgan analyst Tycho Petersen, Foundation Medicine management has said that an "amount in the $2,500-3,400 range would be within the range of acceptable outcomes."

The landscape among commercial payors is a little murky and will partly depend on the tet's inclusion in National Comprehensive Cancer Network guidelines. The firm doesn't know the timing of when that will happen, and Cox noted that NCCN currently still makes decisions by tumor types.

Cox also highlighted the company's strong 2017 growth in revenues derived from pharma partners, $99.7 million compared to $78.8 million in 2016.

Cox said F1CDx is the firm's top priority in 2018, but it is expected to help with sales of the company's other tests including FoundationHeme and FoundationACT, its 62-gene cell-free DNA mutation test launched in 2016. He also said the firm has plans to expand its global footprint this year and strengthen its commercial capabilities with an expanded management team.