Sept. 26, 2023
As published in 360Dx
By Greg Cima
NEW YORK – bioAffinity has its eyes on expanding sales of its sputum-based lung cancer test nationwide through its recent acquisition of the pathology laboratory that had licensed and developed that technology into a laboratory-developed test.
According to its CEO, a national launch of the test called CyPath Lung could happen in 2024.
The San Antonio, Texas-based firm announced Sept. 19 it was acquiring the laboratory assets of Precision Pathology Services for $3.5 million in cash and common stock. bioAffinity CEO Maria Zannes said the deal gives her firm full control over the development and marketing of the CyPath Lung assay as well as all revenues from that test and the laboratory facilities needed to accelerate R&D into the technology underlying the test for additional flow cytometry-based assays.
CyPath Lung, she said, is a powerful, quick assay that is building momentum.
“In a matter of minutes after we gather this big data that comes from the analysis of a sample – we use sputum – we can produce a report for a physician and that report really provides actionable results,” she said.
The firm plans to continue operating the CUA-certified, College of American Pathologists-accredited lab as Precision Pathology Laboratory Services, a slight rebranding that Zannes said takes advantage of the firm’s good reputation from the prior 16 years of operations, primarily in Texas. She said bioAffinity also sees the potential to scale up the lab’s operations to handle rising test volume as the company pushes to expand sales of CyPath Lung in Texas, the southwestern US and, eventually, nationwide.
“One central lab could run all of the samples in the United States should we want to grow Precision into that size of a lab, and that’s certainly possible,” she said.
CyPath Lung is an early detection test for patients who have suspicious CT results. It uses flow cytometry to detect in sputum a fluorescent porphyrin molecule, TCPP, that binds to cancer cells and cancer-related cells. Cells in the sample are also stained with fluorescently labeled antibodies for identification of hematopoietic and epithelial cells. The firm uses Al-assisted algorithms for automated analysis of each sample and provide risk-based scores for the likelihood that a patient has cancer.
Patients who have high scores are the most likely to have cancer and should undergo more invasive testing, and mid-range scores can give physicians information they can use along with other clinical factors such as the patient’s age and lung nodule sizes when considering the next steps.
Zannes said lung cancer has an approximately 21 percent five-year survival rate because it often lacks an obvious clinical presentation in early stages and can go undetected. Early detection through screening could drastically improve five- and 10-year survival. Low-dose CT has a high rate of false positive results that can lead to unneeded and invasive procedures, and Zannes said using CyPath Lung in combination with low-dose CT can give healthcare providers more clarity about what steps to take next.
According to bioAffinity, in a multisite 150-patient validation trial CyPath Lung performed with 82 percent sensitivity and 88 percent specificity among patients at high risk of lung cancer and stages I-IV lung cancer patients. The firm said the test performed particularly well on patients with small lung nodules, with 92 percent sensitivity, 87 percent specificity, and 99 percent negative predictive value in patients with high risk for lung cancer and nodules smaller than 20 mm.
Precision Pathology licensed the testing technology from bioAffinity in 2018 and has been selling CyPath Lung as an LDT, mainly in Texas. Under the terms of that deal, bioAffinity and Precision split the revenues from each test.
“We have worked with Precision for the last five years, we have built a very strong partnership with them, and so the acquisition was very well received,” Zannes said.
The acquisition of Precision quadruples bioAffinity’s headcount, from an 18-employee science-focused test developer to a 72-person combined developer and lab post-acquisition. It also combines the sales and marketing operations related to CyPath Lung under one roof, giving bioAffinity full control over the processes from teaching physicians about the product to collecting samples. No layoffs are planned.
bioAffinity hopes to secure US Food and Drug Administraiton de nova authorization for CyPath Lung, which the firm is supporting with a trial of 1,800 patients who have lung nodules of six mm to 30 mm. The test design involves the combined use of CyPath Lung and low-dose CT, and Zannes expects the trial will take two to three years. However, the firm will continue performing all CyPath Lung tests at its Precision Pathology laboratory, as bioAffinity has no plans to develop a kitted test.
The company also has received notice that the American Medical Association and Centers for Medicare and Medicaid Services intend to provide a CPT code for the test, effective October 1. Although Zannes declined to provide the reimbursement amount for the code, she said it was an attractive recommended price.
The market for early cancer detection tests is heating up, especially among sequencing-based multi cancer early detection tests. Early adopters of Grail’s Galleri MCED have been weighing its value in clinical practice while competitors such as Harbinger Health and EDGC work to bring alternatives onto the market. . A slew of other firms has developed or updated their entries into the lung cancer testing market, including Hummingbird Diagnostics, Delfi Diagnostics, ChromaCode, and C2i Genomics, among others.
bioAffinity sees an advantage in the convenience of home-based sputum sample collection. Patients collect sputum once daily for three consecutive days and ship it overnight to Precision’s lab. Zannes said sputum travels well, making it possible to receive viable samples after days after they have been collected and shipped. According to the company’s website, sputum has a higher concentration of cancer-related cells and other cancer-related materials than blood.
Precision performed about 20 CyPath Lung tests in the last quarter and is seeing rising adoption, Zannes said. It has been particularly well-received in rural communities and small cities where the option of at-home sample collection has resonated well with patients who would have more difficulty making repeated in-person appointments for low-dose CT and invasive procedures. The firm is conducting further market research in Texas and is eyeing a test market launch among pulmonologists in San Antonio ahead of the firm’s anticipated early 2024 national launch. bioAffinity is trying to boost sales through marketing efforts focused on increasing sales through pulmonologists. The firm plans to use the results to refine its physician ordering, sample collection, and results reporting systems before a wider rollout.
Zannes said the firm also plans to apply its newly added research capabilities to its pipeline of assays that use sputum samples and flow cytometry to identify changes in a patient’s lung microenvironment. A test for early diagnosis of chronic obstructive pulmonary disease (COPD) is next in the pipeline, and the firm is in the early stages of research into a test for asthma diagnosis.
She said the firm also is collaborating with researchers at the Brooks Army Medical Center on two small clinical trials, one of which uses CyPath Lung as a front-end test before low-dose CT, and the other intended to develop a lung cancer test that uses bronchoalveolar lavage instead of sputum. The bronchoalveolar lavage-based test would be used with bronchoscopy to provide clearer answers than bronchoscopy alone.
Zannes noted that bronchoscopy is typically used in patients who are at elevated risk of lung cancer, but it can deliver unclear results. Many US Department of Veterans Affairs patients fall into that high risk category because of heavy tobacco use, their age, or both.
“What we hear from physicians is that having a companion test to bronchoscopy that is both highly sensitive and highly specific would be critical,” she said.
Zannes anticipates the company will begin small clinical trials of the COPD and bronchoalveolar lavage tests in 2024. Though “nothing goes fast in our business,” she said bioAffinity’s new assets are letting it hasten development of its testing lineup.