Startups, Diagnostics

Is your chemotherapy working? This simple test could tell you

It takes several months and several tests to determine whether chemotherapy is working. San Diego startup Biological Dynamics just raised $22.8 million for its simple, inexpensive blood test that can tell whether a patient is responding to a cancer treatment.

It’s still largely trial and error to determine the efficacy of cancer treatment – there isn’t any one test that can determine whether a course of chemotherapy is killing off cancer cells.

San Diego biotech Biological Dynamics is developing a pancancer test – requiring just a few drops of blood – that could gauge whether a patient is responding to the given cancer therapy. Its diagnostic, working in the Theranos vein, is meant to be a quick and inexpensive way to monitor treatment response, CEO Raj Krishnan told MedCity News. 

The startup just raised a $22.8 million Series C, coming largely from an unnamed investment fund and several angel investors. The startup is using some of this funding to push some of its cancer diagnostics through the regulatory process – both in the U.S. and internationally.

It takes several months, and a combination of imaging and in some cases, biomarker-based blood tests, to determine whether the chemotherapy or immunotherapy is actually working. Even then, sometimes these tests aren’t effective in patients who don’t express the biomarkers associated with existing tests.

“For chemotherapy patients undergoing expensive, toxic, complicated therapies, it’s almost like Russian Roulette – except that the bullet saves you,” Krishnan said.

Biological Dynamics is meant to provide a faster methodology to determine whether the chemotherapy is actually working, and here’s how:

All cells die from necrosis, after all – so the company’s chasing necrotic DNA that can correspond with all cancers. Biological Dynamics’ platform isolates self-recirculating necrotic DNA –  the free-floating DNA that floats around the bloodstream after a cell has died.

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

Krishnan describes Biological Dynamics’ technology as an “electronic fishing net” that sifts out the big pieces of this cell-free DNA from a small blood sample – then determines whether it’s coming from a cancerous cell.

Right now, Biological Dynamics is choosing which cancers it’ll run by the FDA to approve for a diagnostic, but Krishnan said that the company’s ultimate plan is to create a single-blood-drop-test that could work for any cancer. It can process the samples in under 20 minutes.

Biological Dynamics, founded in 2010, is after a CE mark and is starting FDA clinical studies, with aims to get FDA clearance some time next year. Notably, the company has a strong scientific advisory board that’s led by the storied Eric Topol.