Grail Galleri Test

We learned about the exciting new Grail Galleri Test at the San Antonio Breast Cancer Symposium today! It is a Multi Cancer Early Detection Test (MCED). The earlier cancer is found the higher chances for successful treatment and survival.

Today there are only screenings for six types of cancer; breast, cervical, lung, colorectal, prostate, and skin cancer. The MCED is not meant to replace screenings that we currently use. It will compliment existing screenings and help navigate what follow-up tests are needed, origins of cancer and recommended treatment.

The majority of cancers are asymptomatic until later stages, when chances of survival decrease. In fact, cancers not commonly screened for cause 71% of all cancer deaths. For these cancers that have no existing screening tools, the MCED will detect almost any type of cancer and predict where the cancer cell is coming from. It can determine 21 places of origin in the body – the breast, thyroid, lung, etc. It can detect cancer at earlier stages. This will allow for more precise treatment and earlier intervention.

Cancer cells have DNA mutations. The DNA that come from cancer cells and tumors are circulating tumor DNA (ctDNA). These mutations are shed into the blood stream. The MCED blood test detects these ctDNA in a blood sample that requires just two tubes of blood. The more aggressive a cancer is, the more ctDNA it will shed into the bloodstream, thus not detecting indolent cancers and avoiding over diagnosis and overtreatment.

Using MCED to detect breast cancer the studies are showing a very low false positive rate of less than 1% of only .5%. Currently mammography has a false positive rate of 7-10% depending on age. In addition, for screening for breast cancer, you could find you have another type of aggressive cancer that was asymptomatic.

GRAIL has partnered with 152 institutions including Mayo, Cleveland Clinic and more to study the efficacy of MCED. GRAIL has in place the STRIVE Study, a prospective, observation, longitudinal, cohort study with approximately 100,000 women to validate MCED for early detection of multiple cancers. The participants will be observed for five years to capture data.

It is a hopeful tool to be recommended as a routine annual screening for people fifty and over or those who carry hereditary or high risk factor(s) for cancers. Currently the test is $949.49, however they are working on getting approval for insurance carriers to cover the test. A bill has been introduced to Congress to have the test covered by Medicare - H.R. 1946 – 117th Congress- Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021. It received FDA medical breakthrough to expedite the process and receive FDA approval.

GRAIL Galleri Multi Cancer Early Detection Test could drastically decrease the mortality rate of all cancers. There is much hope for breast cancer and all cancers through science!

Our appreciation to the Alamo Breast Cancer Foundation for the opportunity to stay updated on the latest medical developments in breast health and cancer through the San Antonio Breast Cancer Symposium.