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RESEARCH TRIANGLE PARK – Biofidelity, a medtech company with a lab in Morrisville, is launching new technology with the goal of helping lung cancer patients access targeted treatments more quickly and at lower costs.

Lung cancer is the leading cause of cancer deaths in the US, with more than 200,000 cases diagnosed every year, according to a Biofidelity press release from Tuesday. And while targeted treatments can offer big benefits to lung cancer patients, the company says that 65% of lung cancer patients start treatment without them.

That’s because current tests are too slow to help most lung cancer patients, says Stephen Miller, Chief Commercial Officer at Biofidelity.

“When patients are diagnosed with lung cancer, their first question is, ‘When can I start treatment?’” Miller told WRAL TechWire in an exclusive interview.

He explained that the targeted diagnostics and therapeutics on the market today require a comprehensive biomarker test—and many patients don’t have time to wait for those results.

In the release shared Tuesday, Dr. Kashyap Patel, MD, Carolina Blood and Cancer Care CEO and Immediate Past President of Community Oncology Alliance, commented on the need for new solutions.

“Due to the length of time it takes for current methods of testing to return actionable results, clinicians are faced with the impossible choice of waiting for NGS results before starting non-small cell lung cancer therapy or prescribing what could be sub-optimal therapy for our patients,” said Patel. “It’s time we overcome the complexity and inefficiency of testing that is limiting the potential survival advantage of precision medicine.”

Biofidelity debuts ASPYRE-Lung in the US

Biofidelity is developing “ASPYRE-Lung,” what the company calls “a novel assay that dramatically simplifies and accelerates the detection of biomarkers for non-small cell lung cancer.”

An “assay” is an analysis done to determine how much of one substance is in another substance, according to rx.com.

ASPYRE-Lung can provide biomarker test results within days of diagnosis, enabling clinicians to offer their patients the best possible treatment options more quickly, according to the  release.

Miller says the test is both faster and cheaper than current options on the market.

“Current sequencing-based solutions, like next-generation sequencing (NGS), must identify a few abnormal molecules of abnormal DNA from the 99+% of the patient’s sample which is normal,” said Miller. “It is the equivalent of finding a needle in a haystack, which requires hundreds of steps and is very costly.”

The ASPYRE-Lung assay works differently, with synthetic probes that target only the abnormal DNA or RNA, Miller says—which makes the process faster.

“We eliminate all the steps that would be required to separate out normal from the abnormal DNA with existing sequencing technologies,” said Miller.

And the faster process has cost benefits.

“The price of ASPYRE-Lung is less than half the price of DNA sequencing, and the test covers all of the genes recommended for lung cancer patients by NCCN guidelines,” said Miller.

And since it’s a Lab Developed Test (LDTs) run in a Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited lab, it does not require FDA approval, Miller told TechWire.

Biofidelity’s RTP presence

Biofidelity has a lab in Morrisville, and Miller said there were a number of reasons the company chose the RTP.

“We elected to locate our lab in the RTP area due to the vibrant community, exceptional talent pool, close proximity to a national/international airport, attractive cost of living compared to other US biotech hubs, and the significant number of specialty genetic/genomics labs in close proximity,” said Miller.

According to Miller, Biofidelity’s long-term strategy is “to increase headcount” to support business growth. And that means growing its RTP presence.

“In North Carolina we are currently hiring for an experienced IT Analyst to manage and develop our IT infrastructure in line with security best practices,” Miller told TechWire. “The person in this role will work closely with the UK-based computational team, Biofidelity’s IT provider, and lab colleagues in Morrisville, NC.”

Miller, who’s US-based, also said that the company recently hired a Lab Director based in NC.

Biofidelity has 60 employees, 23 of which are US-based, including the company’s Chief Medical Officer, Wendy Levin, MD, said Miller.

Current and future openings can be found at biofidelity.com.