Thursday, September 10, 2020

Very Brief Blog: GRAIL Files for IPO; Discusses the USPSTF/CMS Process for Preventive Tests

As reported on September 9, 2020, by BioPharmaDive, GRAIL has filed with the SEC for an IPO.

  • See BioPharmaDive here.
    • Coverage at Stat-Plus (Subscription) here.
  • See the SEC Form S-1 online at SEC here.
    • Cloud copy here.
    • Aims to raise $100M during IPO.
    • Molike Ashford of Genomeweb discusses the S-1 in a premium article here.
There have been other large funding events in this space, Freenome raising $270M Series C in August (here) and THRIVE raising $257M in July (here).  

GRAIL makes liquid biopsy tests to detect minimal blood levels of oncogenes and methylated DNA which could be used for screening for cancer.   GRAIL has regularly published results of successful clinical accuracy studies. Its multi-cancer test is now branded "Galleri."  Since mid 2019, the CEO has been Hans Bishop, formerly CEO of biopharma Juno (here).

Generally, prevention or screening diagnostics are covered by commercial insurance and Medicare only after receiving endorsement from the US Preventive Services Task Force (USPSTF).  There are several explicit discussions of this issue in the GRAIL S-1, just search on keyword USPSTF.


Traditional fee-for-service Medicare does not cover screening tests, which are considered preventive services, such as our multi-cancer early detection test unless there is a statutory provision to explicitly authorize coverage. 

Under current law, Centers for Medicare & Medicaid Services (CMS), the agency responsible for administering the Medicare program, is authorized to cover additional preventive services that are not expressly covered by the statute if the service is (a) reasonable and necessary for the prevention or early detection of an illness or disability, (b) recommended with a grade of A or B by the USPSTF, an independent, volunteer panel of experts in the field of prevention, evidence-based medicine and primary care, and (c) appropriate for Medicare beneficiaries. 

CMS establishes coverage through a national coverage determination (NCD) process. This coverage authorization could take several years. Nonetheless, we plan to seek Medicare coverage for Galleri. Because multi-cancer early detection is not expressly authorized for coverage by the Medicare statute, a possible pathway for reimbursement is to first obtain FDA marketing authorization, and then obtain a grade of A or B from USPSTF, to enable CMS to issue a NCD.