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Adrastia Biotech Looks to Bring Urine-Based Breast Cancer Dx to Market


NEW YORK (GenomeWeb) – Adrastia Biotech, a startup developing a urine-based breast cancer diagnostic test, has recently finished a proof of concept for its assay and is now looking to initiate its first clinical trial with hopes of bringing the test to market within two years.

In addition, Adrastia is looking to raise around $1.2 million in a first round of fundraising to support this work, the company's founders told GenomeWeb.

Angela Courtney, co-founder of Adrastia, first decided to explore breast cancer research while obtaining her PhD at the University of California, Davis. During her first year in the program, she was diagnosed with breast cancer and it changed her focus of study to breast cancer diagnostics, where she discovered that options were really limited. From there, Courtney felt strongly that she could come up with a better alternative to mammography.

"Not that mammography is bad," said Courtney, "but there are so many people that it actually doesn't work that well for." For many women, mammography isn't able to pick up masses in their breast tissue or are limited by the ability to only pick up masses at a certain visual size, she said.

By looking at DNA, you can determine whether there are mutations on relevant genes, but you don't know whether the mutation is being transcribed, Courtney said. Instead, Adrastia has identified several mRNA, microRNA, and protein biomarkers.  

It turns out that a good source of both of these biomarkers is urine. "We think of urine as a waste product, because it is, but really it is filtered blood plasma," Courtney said. This makes urine a very useful body fluid to look at since filtration by the kidney takes "a lot of the noise out of the data," but still leaves important traces of what's going on in the proteomic and genomic landscape of that person, she said.

Courtney found that by looking at urine, there is in fact a distinct proteomic and genomic pattern, made up of these protein, mRNA, and microRNA targets, only present in someone who is breast cancer positive and a separate distinct pattern for someone who is breast cancer negative.

Adrastia declined to disclose the equipment and workflow it is currently using for its assay. However, the company said in a statement that it's used targeted sequencing for the mRNA/microRNA biomarkers; and told GenomeWeb that for proof of concept it used mass spectrometry for protein identification.

The company's founders told GenomeWeb that the company does anticipate high demand for the test once it is implemented and plans to employ a standard automated technology to accomplish the high-throughput protein quantification and genomic identification. The company also plans to implement layered quality control.

"[The test] basically delivers on the promise of personalized medicine," said Courtney. "If a woman takes the test in her 20s and she's breast cancer negative, she will actually have her own control." So for this woman, a physician would be able to compare any future test results with her own previous negative result.

In order to further develop and market her product, in 2013 she entered the UC Davis Big Bang! Business Competition and workshop series, which is run through the Child Family Institute for Innovation and Entrepreneurship and helps startup companies collaborate and develop and test business visions. To develop her idea, Courtney teamed up with Michael Gilson, fellow co-founder of Adrastia Biotech and UC Davis alumnus.

"The whole beauty of the urine[-based test] to me was that [it] … has such broad applicability," said Gilson.

The first and foremost application is the possibility of obtaining an accurate diagnosis of either breast cancer-positive or -negative outside of a mammogram or self-examination. This could prove especially important for women under 45 who do not fall under American Cancer Society recommendations for regular mammograms, Gilson said. About 25 percent of the approximately 40,000 women who die each year of breast cancer are under 45 and don't have many diagnostic options, he said.

Another potential application is a way to monitor people who are genetically at high risk of developing breast cancer. Courtney explained that at present the only thing option for women who are genetically high risk is a double mastectomy, since physicians do not currently have non-invasive ways to monitor these women regularly. However, this test could give these women the option to monitor their condition instead of immediately opting for major surgery.

The test also offers the possibility for breast cancer diagnostic testing in communities that have never had it before. The idea would be that this is a test that could be done anywhere in the world, said Gilson, not just in a lab in downtown San Francisco or Manhattan. There are millions of women in the world who don't have access to mammography in their lifetime and might not even be diagnosed with breast cancer until after their death, said Courtney.

"This [test] gives that person, that healthcare provider who is coming to the village to actually provide the healthcare, a way to test and determine whether or not a woman needs to go to a larger facility to be checked out," Courtney told GenomeWeb.

Adrastia is working with an outside consultant to determine the exact target price for its product. The company foresees the test being inexpensive, even in the US, but would look to gain support from non-governmental organizations and the government to help underwrite the cost of the test to prevent a cost barrier in the developing world, Adrastia told GenomeWeb.

The company has filed national and international patents for its technology. "We are hopeful that we should hear good news here [about the patents' issuance] quite soon," said Gilson. The company also plans to begin a clinical trial where it will test approximately 140 samples from patients with well-documented breast cancer by stage and immunohistopathology. It also plans to conduct an additional, ongoing prospective study to follow negative and post-treatment participants over time.

Once the product is ready for market, Adrastia plans to offer it through a CLIA-certified laboratory first. The hope is to have something on the market by late 2017 to early 2018. "We are talking to a European company that seems to have some real interest in making the test available sooner, rather than later," Gilson said.