FDA Events for bioAffinity Technologies (BIAF)
This section highlights FDA-related milestones and regulatory updates for drugs developed by bioAffinity Technologies (BIAF).
Over the past two years, bioAffinity Technologies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CyPath. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CyPath - FDA Regulatory Timeline and Events
CyPath is a drug developed by bioAffinity Technologies for the following indication: For detection of early-stage lung cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CyPath
- Announced Date:
- July 9, 2025
- Indication:
- For detection of early-stage lung cancer
Announcement
bioAffinity Technologies, Inc today released a new case study of a complex clinical case in which CyPath® Lung identified Stage 1A adenocarcinoma lung cancer in a patient whose PET imaging and risk model probability indicated a low risk of malignancy.
AI Summary
bioAffinity Technologies, Inc. released a case study showing how its noninvasive CyPath® Lung test played a crucial role in diagnosing early-stage lung cancer. In a challenging case, a patient’s PET imaging and risk models indicated a very low chance of malignancy—a 0.2% probability—yet the CyPath® Lung test returned a positive result. The test’s score of 0.83 helped reveal a Stage 1A adenocarcinoma, prompting doctors to choose surgical intervention over routine annual CT surveillance. This early detection was critical, as traditional imaging and risk calculators did not provide enough evidence to justify invasive procedures. Early diagnosis is key in fighting lung cancer, and CyPath® Lung’s ability to detect malignancy when other methods fall short may help improve patient outcomes in similar cases.
Read Announcement- Drug:
- CyPath
- Announced Date:
- March 19, 2025
- Indication:
- For detection of early-stage lung cancer
Announcement
bioAffinity Technologies, Inc today released a study of a complex clinical case in which CyPath® Lung's real-time assessment of the lung microenvironment identified a hidden recurrence of breast cancer in an 80-year-old high-risk patient.
AI Summary
bioAffinity Technologies, Inc. released a study highlighting a complex clinical case where their CyPath® Lung test was key in detecting a hidden recurrence of breast cancer in an 80-year-old high-risk patient. The patient, a former smoker with COPD who had previously been treated for breast cancer, was being monitored for lung issues. During routine low-dose CT scans, an indeterminate nodule raised concerns. Traditional methods like PET scans and serum markers were not ideal for further clarification. However, the CyPath® Lung test provided a real‐time assessment of the lung microenvironment, suggesting a likely malignant nodule. This result prompted the care team to conduct a follow-up mammogram, which confirmed a new breast cancer recurrence. The study underscores the potential of CyPath® Lung to guide oncological decision-making and reduce the need for more invasive diagnostic procedures.
Read Announcement- Drug:
- CyPath
- Announced Date:
- March 13, 2025
- Indication:
- For detection of early-stage lung cancer
Announcement
bioAffinity Technologies, Inc announced the release of physicians' case studies showing the benefit to patients and their doctors of using CyPath® Lung, the Company's noninvasive test for early detection of lung cancer.
AI Summary
bioAffinity Technologies, Inc. has released physicians’ case studies highlighting the benefits of using its CyPath® Lung test, a noninvasive method for detecting early lung cancer. The case studies show that CyPath® Lung can help both patients and doctors avoid unnecessary invasive procedures. In one detailed example, an 85-year-old patient at high risk for lung cancer was spared a robotic bronchoscopic biopsy after the test indicated “Unlikely Lung Cancer,” allowing the patient and his doctor to choose watchful waiting instead. This decision led to the resolution of pulmonary nodules over three months.
Dr. Gordon Downie from Titus Regional Medical Center noted that CyPath® Lung provided critical additional information in managing small nodules, enabling a safer approach compared to more invasive options. bioAffinity’s CEO, Maria Zannes, emphasized that these results demonstrate how the test can reduce anxiety and lower healthcare costs by avoiding risky procedures.
Read Announcement- Drug:
- CyPath
- Announced Date:
- January 22, 2025
- Indication:
- For detection of early-stage lung cancer
Announcement
bioAffinity Technologies, Inc announced that the Australian Patent Office (IP Australia), has accepted bioAffinity's patent application for the method of predicting the likelihood of lung cancer used by the CyPath® Lung diagnostic test for early-stage lung cancer.
AI Summary
bioAffinity Technologies, Inc. announced that IP Australia has accepted its patent application for the method used in its CyPath® Lung diagnostic test. This patent covers a process that utilizes automated flow cytometry combined with machine learning to predict the likelihood of lung cancer, thereby aiding early-stage detection.
Once issued, the patent will be valid until 2042, marking a significant addition to the company’s intellectual property portfolio. The acceptance underlines the global potential of bioAffinity's innovation in noninvasive lung cancer screening. The CyPath® Lung test, which highlights malignancy in sputum samples using a fluorescent porphyrin and sophisticated data analysis, stands out as a promising tool to pinpoint early lung cancer when treatments are most effective.
Read Announcement- Drug:
- CyPath
- Announced Date:
- January 13, 2025
- Indication:
- For detection of early-stage lung cancer
Announcement
bioAffinity Technologies, Inc today reported the results of the Company's CyPath® Lung pilot marketing program using Texas for our beta launch with sales of more than 600 tests delivered in 2024.
AI Summary
bioAffinity Technologies, Inc. announced the successful beta launch of its CyPath® Lung pilot marketing program in Texas, delivering over 600 tests in 2024. This achievement highlights the company’s growing impact in noninvasive lung cancer detection and early diagnosis of lung disease. The pilot program has attracted increasing interest from physicians and pulmonary practices, supporting future plans for broader market adoption.
Looking ahead, bioAffinity plans to build on its recent momentum by further expanding its marketing efforts and integrating CyPath® Lung into the U.S. Federal Supply Schedule. This step will make the test available to Veterans and active military personnel across U.S. government health systems, enhancing patient care and early lung cancer detection even more. The success of the Texas beta launch marks a significant milestone in the company’s mission to improve outcomes for patients at risk.
Read Announcement- Drug:
- CyPath
- Announced Date:
- September 18, 2024
- Indication:
- For detection of early-stage lung cancer
Announcement
bioAffinity Technologies announced that CyPath® Lung Test Shows Potential Significant Healthcare Savings by Reducing Unnecessary Follow-Up, Medical Complications and Overdiagnosis
AI Summary
The recent study by researchers at Brooke Army Medical Center and the South Texas Veterans Health Care Systems highlights the potential economic benefits of using bioAffinity Technologies’ CyPath® Lung test for early lung cancer detection. The noninvasive test, which uses advanced flow cytometry and AI, may reduce the need for further diagnostic assessments and invasive procedures. For Medicare patients, integrating CyPath® Lung into the standard screening process could save about $2,773 per patient, reaching total savings of $379 million in 2022. For privately insured patients, the savings may be even higher, averaging $6,460 per patient and totaling around $895 million. By decreasing unnecessary follow-up procedures and reducing procedure-related complications, the test not only helps lower overall healthcare costs but also minimizes overdiagnosis and improves patient outcomes by facilitating earlier and more effective lung cancer diagnosis.
Read Announcement
bioAffinity Technologies FDA Events - Frequently Asked Questions
As of now, bioAffinity Technologies (BIAF) has not received any FDA approvals for its therapy in the last two years.
In the past two years, bioAffinity Technologies (BIAF) has reported FDA regulatory activity for CyPath.
The most recent FDA-related event for bioAffinity Technologies occurred on July 9, 2025, involving CyPath. The update was categorized as "Provided Update," with the company reporting: "bioAffinity Technologies, Inc today released a new case study of a complex clinical case in which CyPath® Lung identified Stage 1A adenocarcinoma lung cancer in a patient whose PET imaging and risk model probability indicated a low risk of malignancy."
Currently, bioAffinity Technologies has one therapy (CyPath) targeting the following condition: For detection of early-stage lung cancer.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:BIAF) was last updated on 7/12/2025 by MarketBeat.com Staff
