RESEARCH TRIANGLE PARK – New funding will help beef up Biofidelity’s presence in North Carolina as it prepares to launch its first commercial product.

The cancer diagnostics company – founded in 2019 in the United Kingdom – has announced the completion of a $23 million fund raising effort to support its ASPYRE-Lung diagnostic assay for lung cancer. The new financing follows the successful completion of a $12 million Series A financing in 2020, bringing the total raised by the company to $36 million.

Biofidelity’s HQ in RTP. (Biofidelity photo)

“Our mission is to ensure all patients diagnosed with cancer have access to the genomic information they need to receive the best treatment,” said Biofidelity CEO Barnaby Balmforth, Ph.D. “This financing is an important step towards making this vision a reality, enabling us to launch our revolutionary technology and to make comprehensive biomarker testing faster, more affordable and more accessible than ever before.”

The company said it plans to almost triple the current workforce at its U.S. headquarters in Research Triangle Park – from six to 15 people – by the end of this year. Global headcount is expected to increase to around 70 employees, 40% of whom will be located in the United States.

The most recent Series A+ investment round, which attracted venture capital firms from Europe and Japan, will support the rollout of commercial operations, according to Biofidelity Chief Commercial Officer Steve Miller. The company’s headquarters located in Morrisville, which opened this past summer, will play an important role.

Biofidelity’s test kit.

The site houses an advanced clinical cancer diagnostic laboratory to perform the ASPYRE-lung assay for oncologists, pathologists, laboratories and pharmaceutical companies. The company’s UK lab will handle research and development before sending the product to the Morrisville facility.

Biofidelity said ASPYRE is a brand new category of molecular diagnostic technology. It simplifies and speeds up the detection of genomic biomarkers through the ultra-sensitive multi-gene characterization of lung cancer mutations from tissue or blood samples.

This information can help physicians identify patients who might benefit from targeted precision cancer therapies that offer better outcomes, including improved survival rates and fewer side effects.

Biofidelity said its technology runs on existing polymerase chain reaction, or PCR machines – the same instrumentation used for COVID-19 testing. So comprehensive genomic biomarker analysis will be available to far more patients globally.

While its initial focus is on non-small cell lung cancer, the company intends to expand broadly to other types of cancer in the future. ASPYRE-lung is expected to hit the market by the end of this quarter.

The genetic evaluation of cancer is typically handled through next-generation sequencing, which can take a few weeks. Biofidelity said it can turn assay results around in just a few days. “The fact that we get results back in one or two days is a disruption in the market,” Miller told the Triangle Business Journal recently. “It’s game changing.”

(C) N.C. Biotech Center