bioAffinity Technologies Inc (NASDAQ: BIAF) is expanding the use of its lung cancer test. The firm aims to apply CyPath Lung to monitor for cancer return in people who have finished treatment. News of this plan revealed in a press release lifted the stock by more than 45 per cent on Tuesday.
The effort focuses on more than 680,000 Americans living after a lung cancer diagnosis. Return rates often range from 20 to 55 per cent, as highlighted by the Texas-headquartered company. Regular scans form the main follow-up, but they can leave uncertainty about whether a new mark is cancer or scar tissue and also expose patients to radiation.
CyPath Lung takes a simple sputum sample and returns a clear likely or unlikely result. This may help doctors decide on further steps and reduce unneeded procedures for patients. For investors, this extended scope of usage may open a larger market for a screening tool that is already selling reasonably well. Test volumes rose 216 per cent year-over-year in the Q2, physician accounts grew 122 per cent and first-half revenue from the test climbed 159 per cent to about US$800,000.
The plan is still its early stages though. Strong past results apply to initial detection rather than post-treatment checks. Full studies for this new use are incomplete. bioAffinity also continues to lose money, though this is typical for a firm at this stage of development. It reported a second quarter net loss of about US$3.4 million.
Read more: Breath Diagnostics advances pre-op pneumonia screening with FDA breakthrough designation
One of a kind system
bioAffinity remains the only company with a commercially available lung cancer test that uses a sputum sample. The test has now been on sale for three years.
Key steps that led up to bioAffinity’s latest announcement include the start of a 2,000-patient long-term study at veterans’ and military sites, a federal distribution deal, and attaining patents in Canada and Australia. Specific case studies have shown the test detecting cancer at its earliest stage, helping avoid risky biopsies in elderly patients and identifying a second primary cancer in a survivor under watch.
These advances helped support the new move into survivor monitoring.
U.S. sector sees momentum elsewhere
bioAffinity’s survivor work comes alongside other progress with American lung cancer screening modalities.
Breath Diagnostics is in advanced stages of development with its OneBreath exhale test. This tool has produced solid accuracy figures in multiple studies involving hundreds of patients. The firm recently raised over US$2.5 million to support further R&D.
Blood tests from American players like Grail Inc (NASDAQ: GRAL) (FRA: NL0) and Freenome, Inc. (NASDAQ: FRNM) are also gaining ground through ongoing studies and regulatory steps.
Read more: Prestigious medtech intelligence firm recognizes Breath Diagnostics for innovation
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