As biotech booms, so do bacteria

by Saemmool Lee

Applying new tech solutions for stubborn health care challenges is big business. At the CITRIS Foundry, in-house startup accelerator of CITRIS and the Banatao Institute, about 40 percent of their current portfolio of companies are either in the health field or life sciences. The startups vary from therapeutics and medical devices to consumer health care, and one cluster is tackling antibiotic-resistant bacterial infections, often called “superbugs.”

“We’re seeing technologies from other disciplines now being applied to health and life sciences,” explains Alic Chen, CITRIS Foundry co-founder. “Along with AI and machine learning, there have been huge advancements in physical technologies such as high throughput screens, and scalable manufacturing methods.” Health startups have generally faced higher costs and higher chances of failure than other startups, but Chen says that
calculation is changing.

“All the components to starting a biotech company – access to expensive capital equipment, access to cutting edge reagents, DNA synthesis and sequencing – the cost for all of these has been dropping precipitously,” Chen says. “And the previous generation of
biotech startups have created the enabling technologies that are now readily available to
today’s startups.”

While bio startups often require bigger investment, their potential to generate high returns offers a competitive advantage. At a CITRIS-sponsored talk on “Building a Successful Bio Startup” last spring, Y Combinator president Sam Altman emphasized that investors think in terms of “return relative to risk” rather than “absolute cost in dollars.” Says
Altman, “People are not afraid of big numbers if the payoff is really big as well.”

It is these changing conditions that have spurred several ambitious startups to tackle previously insurmountable health challenges, namely: bacterial infections.

BioAmp Diagnostics

A pair of Berkeley postdoctoral researchers founded BioAmp Diagnostics to develop rapid point-of-care diagnostic tests to detect antimicrobial resistance in bacteria. The team’s first target is urinary tract infections, the most common bacterial infection worldwide, resulting in nearly two million emergency room visits per year in the U.S. alone.

Antibiotic treatment is usually helpful in treating urinary tract infections, however, there are currently no diagnostic tools on the market to help doctors determine which antibiotic to prescribe at the point-of-care, says BioAmp Diagnostics CEO Tara deBoer. “Over- prescribing and inappropriate prescribing of antibiotics are significant factors driving the
presence of bacteria that are resistant to different drugs,” she says.

Current techniques to detect antimicrobial resistance in bacteria can take up to 72 hours. BioAmp Diagnostics aims to combat the rise of antibiotic-resistant bacteria through the development of innovative diagnostic tests.

“The core technology was developed by Tara and our research group as part of a collaborative effort,” says Nicole Tarlton, co-founder and CSO. “As a company, we are now working to define the first intended use, which will be directed towards improving the treatment of urinary tract infections.”

DeBoer and Tarlton has performed a research study at Highland Hospital in Oakland this past summer to validate the company’s core technology as part of their postdoctoral research, deBoer in Bioengineering, and Tarlton in Infectious Diseases and Vaccinology.

Their first small-scale study was conducted with urine samples from Berkeley’s University Health Services, which were predictably from younger and otherwise healthy individuals. But samples from Highland Hospital represent a much more diverse patient population to better evaluate the limits and potential of the test.

The journal ChemBioChem featured the work on the cover of the October edition. The article, “An enzyme‐mediated amplification strategy enables detection of β‐lactamase activity directly in unprocessed clinical samples for phenotypic detection of β‐lactam resistance,” demonstrates the capacity of the team’s unique strategy to amplify the signal of the target biomarker that confers resistance to beta-lactam antibiotics directly in patient samples.

Next, BioAmp Diagnostics aims to expand its scope into other types of antibiotic resistance mechanisms and bacterial infections, for example, infections in the bloodstream.

mFluiDx

Another CITRIS Foundry startup, mFluiDx, aims to create the most accessible DNA point-of-care diagnostics at the world’s lowest cost in small clinics. “Detecting DNA is one of the fastest and most sensitive ways to detect a disease caused by bacterial and viral infection,” says Berkeley alumnus Charlie Yeh, CEO and founder of mFluiDx.

Currently, it could take days or even weeks to get the results of DNA tests, because primary care doctors need to send patient data to separate testing centers, where the most sensitive DNA test methods are in use. mFluiDx’s product is designed to shorten that time to 15 minutes and reduce the cost 100 times compared to Polymerase Chain Reaction (PCR), the current highly sensitive molecular DNA test.

After an in-house pilot study on campus, Yeh traveled to Africa this fall to test the technology on malaria patients. “The results were looking very good,” he says. “We got perfect matching results with all the other standard testing techniques.” The team is now building a complete proof-of-concept prototype.

“I truly believe that the method we are developing can decrease cost, and this type of technology can have a huge social impact,” says Yeh. “If you save time, you also save cost and improve the patient’s quality of life.”

Nosocom Solutions

CITRIS Foundry startup Nosocom Solutions builds products to prevent and] combat nosocomial infections, that is, infections originating in hospitals and healthcare-associated infections. About one in 25 hospital patients has at least one healthcare-associated infection on any given day in the U.S., according to the Centers for Disease Control and Prevention.

The team has developed a device they call “DCab,” which can automatically disinfect near all bacteria transmitted by lead aprons and white coats in 10-15 minutes with ultraviolet-C radiation.

Research performed at Alta Bates Medical Center in Berkeley and at UC San Diego Medical Center last December demonstrated that DCab was able to achieve 95-100 percent disinfection of bacteria on samplings of lead aprons that carried bacteria.

“People did not know the kinds of bacteria that were growing on lead aprons and white coats, which could be transmitted to patients and also affect healthcare professionals,” says Naresh Sunkara, CEO and co-founder of Nosocom Solutions, also a former postdoctoral researcher at Berkeley. “So, we have to create that awareness before being able to sell the product – hence the longer path to market.”

For every 100 hospitalized patients, 7 in developed countries and 10 in developing countries will acquire at least 1 healthcare-associated infection at any given time, according to the World Health Organization.

“We are creating a new market by identifying a new solution to an old problem that everyone overlooked,” says Sunkara.