Full Press Release Details
With a San Antonio biotech firm’s test, your phlegm could help save you from cancer.
As published by the San Antonio Express-News
By Brandon Lingle, Staff Writer
The screening method devel oped by bio Affinity Technol ogies Inc. uses Al – aided comput er analysis of a patient’s phlegm in a test that can spot lung can cer in high – risk patients earlier than other diagnosis methods . That can be the difference be tween starting treatment when it’s needed or waiting until it may be too late.
“ So many times what a physi cian will say is , ‘ Let’s wait – you have a nodule , it’s concerning , come back in six months . ‘ Or come back in eight months , and you can imagine for people that can cause a lot of anxiety,” said CEO Maria Zannes. “That’s where our test comes in … where there is some kind of question as to whether someone has lung cancer (and) they don’t want to go in and do a biopsy right away.”
Since being launched last year , bioAffinity’s CyPath Lung test has been fueling rapid growth for the company as its market expands across the U.S. That pace is likely to increase after it was awarded a long – term federal contract Wednesday that will streamline the test’s availability to patients served by the Veter ans Health Administration and Military Health System .
With CyPath Lung , bioAffin ity is aiming to fill a gap in a large and growing market , Zannes said . Lung cancer kills more people worldwide than any other type of cancer , according to the World Health Organization . Doctors can treat it if caught early but early detection can be difficult with current testing methods .
The noninvasive CyPath test can help when symptoms or prior test results require more investigation , she said . It only requires the subject taking a shower , breathing into a special device , spitting into a cup and mailing in the sample . Other current testing methods include CT scans and biopsies .
Rapid growth
Since the test received federal approval for patient use last year , it’s seen rapid acceptance by doctors and skyrocketing growth in orders . Interest in the $ 1,900 tests picked up after in surance , including Medicare , began reimbursing the costs .
In the three months through June , total company sales were up 217 % from the year’s first three months . Second – quarter revenue was $ 2.4 million , up from less than $ 20,000 a year earlier . Since Jan. 1, the number of physician offices ordering the test is up 144 % .
“ We’re projecting about 800 tests this year and then moving on from there , ” Zannes said before the federal contract was announced .
The contract announced Wed nesday is likely to boost those projections . Through the Veter ans Health Administration alone , about 8,000 veterans are diagnosed and treated for lung cancer annually , according to the Department of Veterans Affairs .
The company was launched in 2014 and has been working since to perfect and bring its CyPath Lung to market . It’s been pub licly traded since an initial public offering in 2022 , a move Zannes said has helped the company grow .
“ It’s been great to be in the public markets , and we’ve been able to access funds , ” she said . “ It is a difficult time for all small cap companies , but we’ve done okay . ”
As of Friday , the company’s market capitalization was $ 26.14 million .
It has about 100 employees working at its lab and headquarters on the 3300 block of Nacogdoches Road and a re search facility on the University of Texas at San Antonio campus .
After rolling out its flagship test first in Texas and across the Southwest , bioAffinity is expanding it to other markets in the U.S. and planning to take it to Europe and , eventually , Southeast Asia .
In the U.S. , the test’s accep tance has been aided by studies that found it both effective and economical .
A 2023 study published in the journal Respiratory Research concluded the test classified samples as cancer or non – cancer with “ high accuracy . ” And in mid-September, another study published in the Journal of Health Economics and Outcomes Research found that the test could save each patient between about $3,000 and $6,000 in medical expenses by catching the disease early.
It found the cost savings are “ primarily due to reductions in follow – up diagnostic assess ments and procedures . ” Among the study’s co – authors were Dr. Michael J. Morris , a Brooke Army Medical Center pulmonol ogy and critical care physician , and Dr. Sheila A. Habib , director of the Pulmonary Lung Nodule Clinic at Audie L. Murphy Me morial Veterans Hospital.
The Test
Among the reasons for the test’s rapid acceptance is that it’s non – invasive and can be done by patients at home .
It begins with a shower , which helps break up mucus in the lungs . Then , the patient breathes into an Acapella airway clearing device , a handheld plastic tool that further helps dislodge mu cus . Next , they spit into a cup . Three such samples are collected over three days before returning it to the lab .
Upon arriving at Precision Pathology Laboratory Services , a bioAffinity – owned subsidiary , technicians begin a two – day analysis process that involves flow cytometry , a way of measur ing cell characteristics with lasers .
The technique has been around since the 1960s and is widely used to diagnose blood cancers . But Zannes said her company adapted the technology to analyze sputum and screen for lung cancer .
The “ more groundbreaking ” aspect , she said : “ We’ve auto mated it . “
Using machine learning , a subset of artificial intelligence , the company developed an algo rithm to analyze the cytometry data to determine the patient’s likelihood of having lung cancer .
“ After the sample runs through the flow , which takes about half hour , the data goes into this algorithm and out comes the result , ” she said .
It looks at cell populations and how the lung environment is changing .
While the mucus is inside the lungs it captures cells and other markers that can provide hints to the organ’s health . One such marker is a porphyrin , an organ ic compound , that marks cancer and cancer – related cells .
“ There’s a battle going on in the lungs , ” Zannes said . If cancer is there “ you’re going to have more cancer cells , you’re going to have more dead cells and you’re going to have more immune cells , because the immune sys tem is started to fight the can cer. “
Automation is important because each sample might have 16 million cells , and each cell has a dozen or more parameters to evaluate .
“ It’s big , big data , ” Zannes said , and “ machine learning very quickly can determine what kind of (cell ) populations are there . “
The system provides a report that says whether the patient is “ very unlikely , unlikely , likely or very likely ” to have a malig nancy .
What’s Next
Looking forward , Zannes said the company wants to continue its expansion in the U.S. and beyond – and through the mil itary long – term contract . It’s also continued to raise funds through private investment .
“ There are certain areas where we’ve already seen signif icant interest – New Jersey , for example , we have several larger practices there that we’d like to talk to , ” she said . “ So , I think we’ll strategically grow the busi ness . “
The military contract will play a part in that .
“ Lung cancer is the leading cause of cancer – related death in veterans , despite being one of the most preventable cancers in the world , ” Zannes said in a statement . “ My father was one such veteran who died from lung cancer at age 39. That is just one of many reasons I am immensely proud that VA and Department of Defense physicians will be able to order CyPath Lung for their patients to help detect early – stage lung cancer with the goal of leading to better treat ment and longer lives . “
The other part of bio Affinity’s strategy growth is bringing other tests to market . The company now is looking to apply the same technology to screen for chronic obstructive pulmonary disease .
“ Finding COPD early has a similar positive effect on people , ” Zannes said . “It can slow the disease and people can start to make changes that can make a difference and give them a longer life . ”