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Dx Startup Tasso Wins SBIR Grant to Develop POC Sample Prep Module for HIV Viral Load Testing

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Tasso, a two-year-old startup focused on point-of-care, blood-based diagnostics, has been awarded a Phase I Small Business Innovation Research grant from the National Institutes of Health to develop a sample preparation and stabilization device for use with HIV viral load quantification assays.

During the first year of grant funding, worth just shy of $200,000, Tasso will combine its proprietary blood collection technology with a microfluidic exclusion-based biomolecular sample prep method into a single module that the company envisions being operated by a relatively unskilled worker or even the patient before it is shipped to a central laboratory for nucleic acid amplification-based testing.

Provided Tasso can successfully complete the first phase of its project, it also eventually hopes to integrate its device with a point-of-care nucleic acid testing methodology to reduce the economic and logistical barriers around viral load testing for HIV, hepatitis B, and hepatitis C patients.

"We are really focused on making a technology that will reduce as much as possible the cost of many of these steps in the viral load monitoring process," Erwin Berthier, acting president of Tasso and principal investigator on the grant, told PCR Insider.

"We really hope to ultimately reach a product that is going to be simple and cost-effective enough to reduce some of the current barriers of recurrent viral load monitoring … for underprivileged areas of the US," Berthier added. Given this goal, Tasso's grant is being administered by the NIH's National Institute for Health and Minority Disparities.

Tasso was founded in 2011 to commercialize a simple, self-administered, large-volume blood collection device called HemoLink. The device collects up to 500 mL of blood through a patch applied on the arm, and features a proprietary microfluidic handling technology that stabilizes the collected blood for shipping and analysis.

"You would order this patch, it arrives in your mailbox, you use it, and you just have to put it back in your mailbox," Berthier said. "It then gets shipped through a mailing service to a centralized laboratory."

The blood collection process is also relatively painless compared with typical lancet puncture of the fingertip, making it even more conducive to patient use.

In order to create an integrated blood collection and sample preparation device, Tasso has been collaborating with the laboratory of David Beebe, a UW-Madison researcher who has developed several types of so-called "exclusion-based" sample prep methods that combine magnetic beads and the interface of different phases of matter.

In 2011, Beebe was awarded funding from the Bill and Melinda Gates Foundation to develop this technology, described at the time as a "microfluidic immiscible phase barrier to enable simplified sample preparation for point-of-care diagnostics in the developing world."

Berthier said that Tasso is working with a refined version of that technology. "We basically removed the oil interface, [instead] leveraging the liquid-air interface," he said. "That was important because it means that the manufacturing is much simpler, and we don't have to worry about having many different types of fluid on the device."

Berthier said that the Beebe lab technology can extract specific analytes such as RNA, DNA, proteins, or cells from complex samples like blood or sputum in a passive manner through a one-step process that pulls the magnetic beads through this liquid-air interface.

When used in conjunction with Tasso's existing blood collection device, "this allows us to go all the way from sample collection down to having purified RNA on-site, in a very simple device that is entirely passive and entirely disposable, with no electronics."

In fact, Tasso believes the device can be used in the same manner as the standalone blood collection technology. "You put the patch on your arm, collect the blood, [which moves through] this microfluidics technology, and with a simple twisting motion, as if you were unscrewing the cap of this patch device, you can proceed to the sample preparation. The user, without even knowing, basically performs that sample preparation step. We end up with eluted RNA that is stable for a long amount of time, so the laboratory wouldn't even need to do any nucleic acid purification."

The team will use its Phase I SBIR funding to further optimize this process. Should it succeed, Phase II will involve testing the prototype on patients with the assistance of Frank Graziano, an expert in HIV-related clinical trials who is affiliated with the Joint Clinical Research Centre in Uganda, according to the NIH grant abstract.

Furthermore, in Phase II the researchers would explore developing and integrating a nucleic acid amplification and quantitation component that would enable complete sample-to-answer operation at the point of care.

"Our grand vision is: now that we have purified RNA on site, we are basically one step away from doing reverse transcription PCR on site," Berthier said. However, in the short term Berhier believes that Tasso would try to interface with clinical laboratories using established viral load testing platforms from companies such as Abbott or Roche.

"The main market we have in sight so far is HIV diagnostics," Berthier added. "[Eventually] we want to be able to diagnose HIV, hepatitis B, and hepatitis C, which are three major chronic infectious diseases where you want to monitor the viral load over time."

Berthier said that Tasso owns the intellectual property surrounding the blood collection device, but that the patents for the exclusion-based sample prep belong to UW-Madison. The company has thus far subsisted on grant funding, but has begun the process of seeking private investment.

Tasso's Phase I grant began in September and runs through the end of March 2014.

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