Prostate cancer test leads Bio-Techne's expansion into diagnostics

Bio-Techne Corp. is expanding into the realm of diagnostics with its ExoDx Prostate cancer test and a development pipeline of comparable products — a new area of business for the company, best known for selling proteins and antibodies to pharmaceutical developers and researchers.

"I want to get a new leg in the stool for the company," said Chuck Kummeth, CEO of the Minneapolis-based Bio-Techne. "We see this as a billion-dollar or a billion-dollar-plus platform of products over the next ten years."

ExoDx Prostate is a liquid biopsy test that uses a urine sample. Exosomes are secreted from all cells and house biological information. The test analyzes cancer-specific biomarkers to determine a patient's risk of having high-grade or clinically significant prostate cancer. If results show that a patient is higher risk, the next step would be a biopsy.

High-grade prostate cancer is fast-growing. Kummeth said that exosome technology offers a way to diagnose diseases earlier.

"You don't know without good testing what you have. Our test will identify high-grade prostate cancer," Kummeth said.

Baseball legend Cal Ripken Jr. credits the ExoDx test with prompting him to get a biopsy, which detected prostate cancer in its early stages. Ripken was a paid spokesman for ExoDx for two years.

ExoDx became part of Bio-Techne's portfolio through its 2018 acquisition of Massachusetts-based Exosome Diagnostics Inc. for $250 million. At the time, Kummeth said that its technology "is a game-changer."

Exosome Diagnostics was founded on the work of Johan Skog, who is now the chief scientific officer for the business.

"This is a technology that we're now leveraging for a variety of diseases. Liquid biopsies have typically focused on cancer ... but we can do many more things," Skog said. "We can look at cancer as well as neurodegenerative diseases or autoimmune diseases. It's really just a better mousetrap than other types of liquid biopsies."

Bio-Techne also is developing exosome tests for solid tumor mutation, transplant rejection, Sjogren's syndrome and colorectal cancer, according to the company's investor presentation in January.

Last year, Bio-Techne struck a development and licensing agreement with industry giant Thermo Fisher Scientific for ExoTRU, a test to measure if patients are rejecting a kidney transplant. Thermo Fisher is a $45 billion life sciences, diagnostics and lab equipment company.

Thermo Fisher is based in Waltham, Mass., as is the Exosome Diagnostics business.

Kummeth said that Bio-Techne will look to partnerships and licensing arrangements for some exosome pipeline products and would keep others for itself.

"We are working with big pharma," said Kummeth.

Bob Wasserman, a senior research analyst with New York-based Benchmark, said that he sees encouraging signs of growth for Bio-Techne's new diagnostics.

"It's been a smaller part of the business. It's an area of growth that they're looking for," said Wasserman. "So far it's been slow ... They thought that this would be a nice niche."

Wasserman said that the diagnostic tests open the company up to new markets. Historically, he said, Bio-Techne has sold its products more to other businesses than consumers.

Bio-Techne closed its Exosome Diagnostics facility in Germany in 2022 as part of a restructuring of the division.

The company's revenue increased 3% in the first six months of fiscal 2023 over the same period of 2022. Income was down about 1% to $139.7 million for that period.