bioAffinity Technologies grows lung-test sales but flags funding needs

Nine-month lung-test revenue rose 79 per cent as bioAffinity Technologies, Inc. NASDAQBIAF reported results on Nov. 6 alongside a going-concern warning. Cash stood at approximately US$2.6 million on Sept. 30, and management said further capital would be needed unless operating revenue increased significantly.

The results release put CyPath Lung testing revenue at approximately US$1.1 million for the first nine months of 2026. That growth did not extend to total quarterly revenue, which fell to approximately US$1.1 million from US$1.4 million a year earlier.

BioAffinity is a small San Antonio diagnostics developer commercializing a sputum-based lung-cancer test through its pathology laboratory subsidiary. Its third-quarter net loss widened to approximately US$5.3 million from US$5.1 million, leaving commercialization dependent on financing as well as sales.

BioAffinity NASDAQBIAF shares closed at US$2.72, up 4.42 per cent, on Nasdaq at 4 p.m. EST on Nov. 6, according to Google Finance. That close preceded the results release at 5:40 p.m. EST and therefore does not establish investors' reaction to the announcement.

Higher Orders Have Not Removed Funding Needs

CyPath Lung unit sales doubled through September compared with the first nine months of 2025. During the third quarter, the number of ordering physicians increased 89 per cent year over year, while existing physician customers increased their test volume by 48 per cent.

Revenue growth lagged the increase in test units. BioAffinity attributed the decline in total quarterly revenue primarily to lower average CyPath Lung reimbursement and a slight reduction in cases completed at Precision Pathology Laboratory Services.

The company said internal business changes at three laboratory research clients contributed to the decline. Multiple accounts had since returned, and management was working to recover more accounts and improve reimbursement.

Read more: bioAffinity Technologies reports more than 1,620 CyPath Lung tests

The filing's going-concern note says significant losses and negative operating cash flows have persisted since inception and are expected to continue. Management concluded that substantial doubt existed about the company's ability to continue for at least twelve months after the financial statements were issued.

Further funding could come through equity, debt, strategic relationships, grants or other arrangements. Without acceptable funding, the company said its development plan could be curtailed; exercises of outstanding warrants were another possible source, with no guarantee.

BioAffinity reported US$8 million in combined gross proceeds from August and October financings for working capital and general corporate purposes, including CyPath Lung commercialization. The September cash balance precedes the October transaction and should not be treated as post-financing liquidity.

Lung Diagnostics Face A Revenue Conversion Test

Biodesix, Inc. NASDAQBDSX also reported test-volume growth outpacing revenue growth. Its Nov. 5 results showed third-quarter diagnostic testing revenue rising 16 per cent as volumes increased 24 per cent, partly offset by lower average revenue per test.

Biodesix attributed its lower average revenue primarily to a larger share of Nodify CDT tests. The companies' explanations differ: bioAffinity cited lower average reimbursement, alongside laboratory account disruption.

Read more: Biodesix adds lung imaging test to pipeline with 2028 launch target

The broader biotechnology market gained on Nov. 6: the iShares Biotechnology ETF NASDAQIBB closed at US$213.63, up 1.73 per cent, at 4 p.m. EST, according to Google Finance.

BioAffinity's longitudinal study had eleven active sites on Sept. 30, including nine VA and military centres that had begun enrollment. The company is also exploring surveillance following lung-cancer treatment.

"We are also advancing its potential use in surveillance following curative-intent treatment, where CyPath Lung could complement imaging in monitoring for recurrence and new cancers," bioAffinity chief executive Maria Zannes said in the release.

For the fiscal year ending Dec. 31, the remaining quarter will test whether stronger ordering translates into revenue while bioAffinity seeks capital to sustain commercialization.