NEW YORK ─ Tasso is seeking US Food and Drug Administration Emergency Use Authorization that would enable convenient at-home blood collection for SARS-CoV-2 serology testing in laboratories, and pressing forward with initiatives to enable at-home blood collection for a range of other medical conditions.
The Seattle-based firm, fresh off of a Series A financing round that netted $17 million, already supplies its on-demand blood collection devices for research to academic medical institutions, government agencies, cancer centers, and pharma organizations, Ben Casavant, the firm's cofounder and CEO, said in an interview.
Its product is being validated for use in routine diagnostics, chronic disease monitoring, infectious disease surveillance, sports testing, and virtual clinical trials.
Importantly, a recently completed validation study has proven that its Tasso OnDemand at-home blood collection devices enable equivalent results to venipuncture for coronavirus serology testing, which should convince the FDA to grant authorization, Casavant said.
Blood collection has not been the most innovative part of in vitro diagnostic technology development. Venipuncture, once used for bloodletting to cure or prevent disease, has dominated as a method for drawing blood for testing by injecting a needle into a vein. Though most blood collection is done with an evacuated tube system that has been available since 1985, some blood tests are also conducted on capillary blood obtained by fingerstick.
To facilitate simpler blood collection, companies such as Tasso and others have pushed the envelope of innovation for blood collection by exploring products that could complement or provide an alternative to venipuncture, help decentralize testing, and reduce long wait times in hospitals and clinics.
According to Casavant, Tasso's devices are about the size of a ping-pong ball and, in use, are temporarily adhered to the user's shoulder. Pushing a button triggers the release of a lancet and initiates a vacuum. For about three minutes, microfluidic channels within the device pull blood into a tube that is subsequently mailed to a laboratory, a process far more convenient and less daunting than showing up at a clinic to have a needle inserted in a vein, according to Casavant.
If the firm is successful with its FDA submission, it would be among the first companies authorized to provide a product for blood collection used for SARS-CoV-2 serology testing in the US. The FDA has authorized a number of serology tests and at-home collection of swabs or saliva for RT-PCR tests during the pandemic. However, it hasn't authorized at-home blood collection for serology tests.
In its validation study, which included about 90 participants, Tasso had to demonstrate that its blood collection system and the processes of shipping and transportation didn't affect the performance of an undisclosed serology assay. The study ─ specifically for self-use ─ also included simulations of shipping under harsh conditions, above and beyond what the sample is likely to encounter in clinical use. "For us, showing performance is not about sensitivity and specificity, but about how much bias we are putting on the sample that could affect the assay's performance," Casavant said, adding, "We showed virtually no bias and strong reproducibility in a comparison with gold-standard venipuncture."
According to Casavant, Tasso's technology can be used for a number of different diseases and with different types of testing platforms, including molecular and antibody tests.
The company plans to use the proceeds from its Series A financing to scale manufacturing and operations to meet the demand for its push-button blood collection devices. To date, it has raised $38.6 million from funding awarded by the US Department of Defense's Defense Advanced Research Projects Agency, DoD's Defense Threat Reduction Agency, and the National Institutes of Health; investments from private venture firms; and codevelopment deals with other entities, the firm said.
In collaboration with the National Institutes of Health, for example, Tasso is working with approximately 12 academic medical center laboratories, Casavant said. The company is supplying its products to Cedars Sinai Medical Center in Los Angeles, one of its investors, for research use in a CLIA-certified laboratory. And Tasso has a research contract with Merck for use of the blood collection products in clinical trials.
"We see an important role for our products in enabling safe and convenient serology testing for COVID-19 patients, but in general, we are looking to provide access to care and diagnostics for many medical conditions," Casavant said. "Blood testing labs are handling billions of samples annually in the US, and Tasso is a way to extend access to such critical blood tests."
Casavant noted that outside coronavirus testing, diabetes testing presents an example of one area in need of the kind of home collection and testing enabled by Tasso. Diabetes patients need to monitor their levels of A1C on an ongoing basis. Some also need to take tests for kidney disease and conditions that could lead to heart disease, which are comorbidities associated with diabetes, he added.
Tasso is also working with anti-doping agencies, he said, and seeking to provide its products for the testing of athletes during the Olympics. The company offers a dried-blood-spot sample collection product that enables the storage of blood in harsh operating conditions, such as widely varying temperatures, and enables samples to be stored without refrigeration, which is useful for testing in low-resource and remote settings.
During the pandemic, the ability to conduct blood draws in the home and send samples to the lab means patients can avoid hospital visits, which can be especially important for those wanting to avoid exposure to coronavirus patients. Casavant said he believes that the coronavirus pandemic has amplified the need for diagnostic products that can be easily deployed at home.
Christopher Aulin, CEO of Stockholm-based at-home blood-collection startup Capitainer, said with the advent of the pandemic "the need for these types of products is exploding."
Aulin is familiar with Tasso but unaffiliated with the company. "We believe strongly that home sampling is a great complement to venous sampling," said Aulin. Investment in research and product development by Capitainer and, separately, Tasso is likely to pay dividends "when the demand for quality, consistency, and trust in the [home collection method] increases," he said. Like Tasso, Capitainer has started the FDA EUA submission process for COVID-19 antibody testing, Aulin said.
Tasso has been developing its technology since 2011 and in 2013 was 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.
Other developers of new blood collection systems include Magnolia Medical Technologies and Kurin.
Further, Becton Dickinson and Babson Diagnostics are also looking into alternatives to venipuncture. They are pulling together their resources in a bid to get retailers, including pharmacists, involved in the collection of capillary blood samples for testing. Testing would be done at a CLIA-certified laboratory, with results delivered to clinicians the same day or the next day.
The FDA in June granted EUA for a Babson Diagnostics SAR-CoV-2 immunoassay but not for its use along with at-home blood collection.
Overall, the agency granted dozens of authorizations to diagnostic companies for serology tests, but the rate of authorizations for such testing has slowed recently, and none of the authorizations allow at-home collection for serology testing. The agency has said in the past that at-home collection raises unique concerns about safety and accuracy, including whether a sample can be collected safely and properly by a layperson, and whether the sample can be shipped in a way that’s stable to ensure an accurate result once it reaches the lab.
Casavant said he believes that serology testing is and will be an important part of the overall testing toolbox for COVID-19. In addition, to help determine whether there is immunity and how long immunity might last, antibody tests are needed to determine whether people are responding to vaccines that are in development, he said.