Biotech company bioAffinity Technologies and medical device maker Smiths Medical have partnered to boost patient care with at-home collection of sputum, which can be analysed by a non-invasive flow cytometry diagnostic test for lung cancer, CyPath Lung.
The diagnostic test is being developed as a Laboratory Developed Test (LDT) by Texas-based Precision Pathology Services.
bioAffinity Technologies president and CEO Maria Zannes said: “The partnership enables the use of the acapella vibratory PEP therapy system made by Smiths Medical for at-home collection of samples that are analysed by bioAffinity’s CyPath Lung, a patient-friendly test shown to have high sensitivity and specificity in detecting lung cancer in people at high risk for the disease.”
“One of the hallmarks of CyPath Lung is the ease, by which patients collect their sputum samples at home, using the acapella device.”
Smiths Medical CEO JehanZeb Noor said: “Innovation is a cornerstone of Smiths Medical. As a leader in airway management solutions, we are proud that our acapella device can facilitate the use of this non-invasive breakthrough test that can detect lung cancer at its earliest stages when treatment can be most effective and lives can be saved. Smiths Medical and bioAffinity Technologies share a commitment to putting patients first and making quality healthcare accessible and affordable.”
As a flow cytometric test, CyPath Lung helps in the diagnosis of lung cancer. Patients can gather sputum samples non-invasively at home through the acapella device. The laboratory can then process the samples.
Sample data is gained by flow cytometry, which is a technique that can not only count but also quickly sort and profile individual cells.
Using an automated analysis with parameters that are pre-set, CyPathLung makes a profile of the lung micro-environment, including the presence of cancer-associated cells. Test results are available in minutes.
A validation trial of the test carried out by bioAffinity Technologies, comparing people who are at high risk for lung cancer to high-risk patients with the disease, indicated CyPath Lung specificity of 88% and sensitivity of 82%, just as the far more invasive procedures used in the diagnosis of lung cancer.
In the cohort of cancer and cancer-free high-risk participants who had no nodules or small nodules of less than 2cm in diameter, CyPath Lung has performed even better with 92% sensitivity and 87% specificity.