The Mercy Halo™ Test

Cancer deaths and cases continue to rise1

%

Rise in male cancer deaths

%

Rise in female cancer deaths

%

Rise in new cancer deaths

Cancer survival is 5-10x higher
when cancer found at early stage (stage I or II)2

A number of companies are exploring early cancer detection today. Most are based on analysis of circulating tumor DNA, or ctDNA. ctDNA is very scarce in early stage cancers,3 making it challenging and expensive to detect. In fact, ctDNA has not been shown to reliably detect when cancer is found at an early stage.

"Right now, we don't have anything that detects early stage cancer. And by the time we see them, they're stage 3 or stage 4 and their five-year survival is close to zero."

Dan Sherry, OB-GYN

The Mercy Halo™ Test is different

Halo is the first and only test for early cancer detection based on analysis of single extracellular vesicles (EVs), contained in abundance on every human cell and precisely traceable to their tissue of origin.

The large amount of available EV material for analysis in every simple blood draw, and its tumor specificity, have the potential to make cancer detection at every stage easier, more accurate and less expensive.

EVs are abundant
EVs are abundant

EVs ARE ABUNDANT

We hypothesize that a 1 mL blood draw from a stage 1 cancer patient, with a one-centimeter tumor, contains ~100,000 tumor-derived EVs. The same blood draw contains <1 copy of ctDNA3 One active tumor cell secretes ~1,000 EVs per day, every day. That same cell secretes no ctDNA until it dies, when it secretes 2 copies of ctDNA4,5
EVs are tumor specific

EVs ARE TUMOR SPECIFIC

Surface proteins on EVs carry information about their tumor of origin4 EVs can theoretically enable the detection of tumors less than 1 mm in diameter, small even for stage I cancer
EVs are tumor specific
EVs are stable
EVs are stable

EVs ARE STABLE

EVs are more stable than ctDNA, enabling Mercy to benefit from previously stored samples collected in large screening studies6

The Mercy Halo™ Test is different

Halo is the first and only test for early cancer detection based on analysis of single extracellular vesicles (EVs), contained in abundance on every human cell and precisely traceable to their tissue of origin.

The large amount of available EV material for analysis in every simple blood draw, and its tumor specificity, have the potential to make cancer detection at every stage easier, more accurate and less expensive.

EVs are abundant
EVs are abundant

EVs ARE ABUNDANT

We hypothesize that a 1 mL blood draw from a stage 1 cancer patient, with a one-centimeter tumor, contains ~100,000 tumor-derived EVs. The same blood draw contains <1 copy of ctDNA3

One active tumor cell secretes ~1,000 EVs per day, every day. That same cell secretes no ctDNA until it dies, when it secretes 2 copies of ctDNA4,5

EVs are tumor specific
EVs are tumor specific

EVs ARE TUMOR SPECIFIC

Surface proteins on EVs carry information about their tumor of origin4

EVs can theoretically enable the detection of tumors less than 1 mm in diameter, small even for stage I cancer

EVs are stable
EVs are stable

EVs ARE STABLE

EVs are more stable than ctDNA, enabling Mercy to benefit from previously stored samples collected in large screening studies6

EVs in Early Cancer Detection

Robust peer-reviewed literature demonstrates the potential of EVs in early cancer detection.

Our Initial Focus: Hard-to-Treat Cancers

Some cancers are more dangerous than others. It is our mission to develop a portfolio of early detection tests for a variety of difficult cancers in order to save more lives.
ovarian cancer

Ovarian

Ovarian cancer often causes no symptoms in its early stages, and so is detected in its late stages 80% of the time, when it has already spread. Each year in the USA, almost 14,000 women will die of ovarian cancer and almost 22,000 new cases will be diagnosed.7 There is currently no early detection test for ovarian cancer.

lung cancer

Lung

As the #1 cancer killer among both men and women, more people die from lung cancer each year than from colon, breast, and prostate cancers combined.8 Lung cancer symptoms usually do not appear until the disease is at a later stage. Even when symptoms appear, many people may misdiagnose themselves with an infection or side effects from smoking.

Mercy Halo™ Clinical Evidence

Evolution of the Mercy Halo Ovarian Cancer Test for High-Grade Serous Ovarian Cancer

Evolution Table

References

  1. Centers for Disease Control and Protection, Expected new cancer cases and deaths in 2020, updated August 16, 2018
  2. Aravanis AM, Lee M, Klausner RD. Cell. 2017; 168(4):571–574, 9.
  3. Bettegowda, et al. Science Translational Medicine. 2014; 6(224).
  4. Larssen, P. et al. Tracing cellular origin of human exosomes using multiplex proximity extension assays. Mol. Cell Proteom. 2017; 16, 502–511.
  5. Castillo, J. et al. Surfaceome profiling enables isolation of cancer-specific exosomal cargo in liquid biopsies from pancreatic cancer patients. Ann. Oncol. 2017; 29, 223–229.
  6. Ferguson, S. and Weissleder, R. Modeling EV Kinetics for Use in Early Cancer Detection. Advanced Biosystems. 2020; p.1900305.
  7. American Cancer Society, Key statistics for Ovarian Cancer.
  8. American Cancer Society, Lung Cancer Early Detection.