San Diego company’s test to detect pancreatic cancer in early stages moves to human trials

For more than a decade, Biological Dynamics has been working on technology licensed out of UC San Diego to enable early detection of diseases ranging from cancer to tuberculous to Alzheimer’s.

Now, that technology has matured to the point where the San Diego biotech firm is eyeing commercialization of its initial product — a lab-on-a-chip plasma test to uncover pancreatic cancer before it’s too late.

The 76-employee company, which counts Qualcomm co-founder Irwin Jacobs as an investor and chairman of its board, has received regulatory clearance to begin enrolling high-risk patients in a clinical study to validate its lab-developed test for pancreatic cancer. When diagnosed in late stages, the disease has a five-year survival rate of less than 12 percent.

“We want to show in patients, particularly patients who have high risk, that we can improve the number of patients who are detected at the early, curable stage than the current standard of care,” said Dr. Paul Billings, chief executive of Biological Dynamics.

The clinical study is called ExoLuminate. It has one patient enrolled so far. The company expects to conduct the study at roughly 50 sites throughout the globe.

Founded in 2009, Biological Dynamics has developed proprietary technology that repels red blood cells and platelets to exclusively isolate exosomes — which are tiny structures inside a cell that contain some of the cell’s proteins, DNA and RNA. The lab-on-a-chip then detects the concentration of a handful of individual bio-markers specific to pancreatic cancer.

The technology, which can be “tuned” to pinpoint other diseases, came from well-known nano-engineering professor Mike Heller’s lab at UC San Diego. There, researcher and Biological Dynamics founder Raj Krishnan, figured out how to use alternating current to ferret out very small bio-markers from blood and other liquid solutions.

“No one thought you could use alternation current to successfully isolate cells or other proteins — DNA or RNA — because the thought was the alternating current and charged molecules did something that would be toxic to either the cells or the proteins,” said Billings.

The company has raised $125 million since its founding to refine the technology. Biological Dynamics has 49 patents either granted or pending around its UCSD technology license.

There are other early cancer detection tests available, most notably from Grail, which San Diego gene sequencing giant Illumina acquired last year for $7.1 billion.

Grail claims to be able to detect 50 different types of cancer from a single blood draw. Anti-monopoly regulators in Europe and the U.S. have challenged Illumina’s acquisition of Grail, with legal proceedings ongoing.

Asked about competitors, Billings said Biological Dynamics expects the overall costs of using its technology to be less than gene sequencing methods.

After the pancreatic cancer study, the company aims to expand into diagnosing other cancers, said Billings.

“Within the next 12 months, our plan is to commercialize the early pancreatic cancer test and to then begin a similar process for an early ovarian cancer test and an early lung cancer test as well,” he said.