According to the World Health Organization, tuberculosis is the second greatest killer worldwide due to a singular infectious agent (a bacterium called Mycobacterium tuberculosis). Only HIV/AIDS is more deadly. All but 5 percent of TB deaths occur in low- and middle-income countries, and it is among the top five causes of death in women ages 15-44.
Between 2000 and 2013, an estimated 37 million lives were saved through TB diagnosis and treatment. A Branford, Connecticut-based startup aims to greatly increase that number. Tangen Biosciences, founded by John Nobile, a mechanical engineer and UConn graduate with more than 40 patents to his name, and John Davidson, Ph.D., a Harvard-educated biochemist and researcher, have developed an instrument that provides fast and accurate diagnosis by detecting “DNAs of interest” directly from patient samples. The innovation—a portable device about the size of a smartphone—is faster, easier to use, and less expensive than existing commercial technologies, and does not require a skilled operator or a laboratory in order to work.
Speed and accuracy of diagnosis are critical for containing the spread of TB. They’re also crucial to the eventual eradication of the disease. According to Nobile, the current rapid diagnostic techniques take two hours and are not sensitive enough, while the sensitive techniques are quite slow, taking from 2-6 weeks. “From the beginning, we set out to create a platform that would be more sensitive than the best available techniques, but with a speed on par with the fastest available tests,” he said.
Although Tangen’s device can be used to detect many diseases, the company’s co-founders are focusing on tuberculosis first. “Rapid and accurate TB diagnosis is a huge unmet need in both the developing and developed world,” said Nobile. “The predominant diagnostic methods used today are about 100 years old and not very effective.” The focus is also personal: Both Nobile and Davidson have family members who were affected by TB in the early part of the last century.
Tangen’s founders approached Connecticut Innovations for funding after learning of the state’s venture arm through an advisor. After conducting due diligence, CI approved a $150,000 investment from its pre-seed fund in January 2014. (Tangen also received funding from a private angel investor.) Later that year, in December, the Connecticut Bioscience Innovation Fund (CBIF) made a $500,000 investment in the company. Nobile and Davidson used the funds to produce data that proved its prototype was effective—important not only for the eventual marketing of the platform but also for attracting new investors—and to hire more full-time employees.
With funding in place, Tangen Biosciences conducted its first blind clinical sample trial for infectious tuberculosis detection using 150 samples from the WHO TB sample bank, and submitted the results to the Foundation for Innovative New Diagnostics for review. The company’s system demonstrated sensitivity and specificity on par with the best-state-of-the-art molecular diagnostics systems.
Tangen is currently raising a Series A round to help finance clinical testing and an FDA 510(k) submission. (The FDA 510(k) submission serves to demonstrate that the device to be marketed is at least as safe and effective as a current legally marketed device.)
The funding from Connecticut Innovations and other sources, coupled with the initial data from the TB study, along with continued conversations with its scientific advisory board, signaled to Tangen that its novel technology has the potential to be used in many different disease indications. That includes MRSA, an infection caused by staph bacteria that has become resistant to antibiotics.
As of October 2015, the company has six full-time employees.
Tangen Bioscience’s instrument provides rapid nucleic acid detection, with the specificity and sensitivity of polymerase chain reaction (PCR) amplification, in a format that does not require laboratory resources or highly skilled operators. These characteristics enable accurate detection of DNAs of interest directly from patient samples faster, simpler, and at a lower cost than existing commercial technologies, all while being delivered in a portable form factor that does not require a laboratory.
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