San Antonio — For bioAffinity, a company that relocated its diagnostic research program to San Antonio two years ago, the proof is in the sputum.
BioAffinity, the maker of a diagnostic test that is currently focused on lung cancer, aims to use its technology to identify whether cells in a person’s sputum are cancerous, thus indicating he or she may have a tumor. After bioAffinity collects the sputum—basically phlegm that’s coughed up from the lungs—it adds its diagnostic agent, called CyPath, which is a type of molecule known as a porphyrin.
It’s bioAffinity’s belief that the porphyrin—a type of naturally occurring molecule in the human body, though bioAffinity’s is synthetic—will be absorbed more by cancer cells than noncancerous cells. A unique characteristic of porphyrins is that they will fluoresce or light up under certain conditions, the company says. So when a cancer cell takes up bioAffinity’s porphyrin more readily than a regular cell, the company says it can measure the amount of cancer cells there are in a person’s sputum because the ones with more porphyrins emit a different light.
BioAffinity says it is aiming to raise a round of $10 million in venture funding to continue its study of the agent and, potentially, commercialize it. It plans to initially target high-risk people who might receive low-dose computed tomography (CT) scans, a group of 14 million Americans who receive scans each year, according to bioAffinity CEO Maria Zannes.
A large percentage of those diagnosed with a tumor by CTs do not actually have one, Zannes says. BioAffinity aims to be a second test after someone receives a positive CT scan, believing it can better show when a person will test positive, reducing the number of bad diagnoses.
BioAffinity wants to possibly prevent something like an unnecessary biopsy, which is a typical next step, she says. Plus, the test is noninvasive and relatively cheap—$150 to $300—so if it is able to prove its effectiveness, it could be more broadly used than just as a companion to CTs, she says.
“Our vision is to have this test used on a global market,” Zannes says. “The beauty of the test is that it is simple in its application, and therefore can be used not just in the first-world countries that have top healthcare, but in countries that are not able to have low-dose CT or imaging or more expensive technologies.”
The company still has plenty of work to do before it gets to commercialization, in part proving out its ability to accurately differentiate cancer patients from noncancer patients. In July 2015, it published results from a study it completed in 2011, which showed that the test was indeed successful at classifying which patients had cancer and which ones didn’t. Now, in San Antonio, the company is contracting research out to the University of Texas Health Science Center at San Antonio to try to improve the test and to study why the cancerous cells take in the porphyrin.
Zannes says that the San Antonio researchers have already had some success by using a machine called the Opperetta, an imaging system that automates the process of examining the sputum, which was previously done slide by slide, Zannes says. The machine can process sputum more quickly, and can measure an entire sputum sample, while previous studies only measured one-third of a sample. It also more accurately measures the fluorescence of the cells, she says.
“It provides an automated system for analysis,” she says. “The more we look, the more accurate we find the assay to be.”
The company is also licensing its technology to Meridian Health System, a group of six hospitals in New Jersey. BioAffinity may use any data collected there as a part of a broader patient-centric study it hopes to produce in the next two years.
The researcher and surgeon at Meridian who is working with bioAffinity, Thomas Bauer, was also the lead investigator of the study the company completed in 2011. That study focused on veterans and was funded through $1.6 million in grants from the state of New Mexico (more on that below).
While the veterans study was an important step for the diagnostic, it was not easy to accomplish. It was completed while CyPath was owned by another company that Zannes also ran—Albuquerque, NM-based Biomoda, which filed for Chapter 11 bankruptcy in 2013.
Zannes, an attorney by trade who has experience as a consultant, came to the company in 2008. She had recently moved to New Mexico to support a brother, Tom, who was suffering from glioblastoma. After he passed, her other brother, Timothy, asked her to join the board of directors of Biomoda, where he was the general counsel.
Given her family’s history with cancer—besides her brother, Zannes’s mother fought breast cancer and her father died from lung cancer—Zannes says she decided to stay with the business, which was traded publicly over the counter. She helped secure the $1.6 million in grants for the early trials, and eventually took over the role of CEO of Biomoda in late 2010.
The company hit financial trouble, in part because of deals it made with hedge funds that controlled warrants that could be used to buy stock at very low prices, Zannes says. Zannes says the warrants suppressed the company’s stock price, so that Biomoda could not find additional investors to raise capital.
In April 2012, Biomoda took on a couple of convertible loans, totaling about $450,000 in value, from unnamed lenders to continue operating. If the company defaulted on the loans, its patents were at risk—the company has 41 now, Zannes says—and the deal also made it possible for the lenders to “convert their loan to equity in Biomoda in the event the Company restructures its business,” according to regulatory documents.
Biomoda’s bankruptcy documents show that the 2012 lenders were Steven Girgenti—now bioAffinity’s chairman—and 10 other individuals or limited liability corporations. In the end, a group of 13 investors provided $2.4 million of financing for 14.6 million shares of the reorganized company, according to the reorganization plan.
“The interesting thing is with many of the investors, they’ve been touched by cancer, or a loved one has died or has cancer,” Zannes says. “It’s a group who wants to do well. They want to not only invest, but they want to invest in something that makes a significant difference.”
Zannes attempts to distance bioAffinity today from the previous company, citing a new group of investors and changes to the management team. Zannes left Albuquerque in 2014 for San Antonio because of the research contract with the UT Health Science Center, and she incorporated bioAffinity with the Texas Comptroller’s office in May of that year. BioAffinity leased an office from The Texas Technology Development Center, which is part of the Texas Research & Technology Foundation, but it has since moved its office to UTSA.
The next target for bioAffinity, Zannes says, is securing venture funding and expanding the company’s research on the diagnostic.