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Houston health tech startup launches game-changing, at-home coronavirus testing

Houston-based Imaware has launched at-home testing that can identify if the patient has — or even had — the coronavirus. Photo via imaware.health

Politicians, scientists, public health officials, and others continue to stress the need for widespread testing to tame the spread of the novel coronavirus.

Houston-based startup Imaware, an at-home health testing platform, recently rolled out an at-home coronavirus test for high-risk people, such as someone with both a fever and recent exposure to someone infected with the virus. Now, it's gearing up to offer an at-home test designed to spot the presence of coronavirus antibodies in your blood.

Experts view antibody testing as a key to corralling the virus and rebooting the virus-crushed U.S. economy. However, some skeptics fear the benefits of antibody testing are being oversold.

As explained by Health.com, a nasal swab test can detect a coronavirus infection. But a blood test can pinpoint whether a person has been exposed to the novel coronavirus, which causes the COVID-19 respiratory illness, and might now be immune to it.

Jani Tuomi, co-founder of Imaware, says his company is working with the U.S. Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) on approval of Imaware's antibody test. The in-home blood test might be available as early as May.

"We're still trying to make sure that everything checks out and validation is completed," Tuomi says, "but it looks like it's headed in the right direction."

In early April, the FDA approved the first test in the U.S. to detect coronavirus antibodies.

Tuomi says the process for Imaware's coronavirus antibody test will be similar to the one for the coronavirus detection test. Both tests, for instance, will be administered by licensed clinicians.

Here's how the basic test works.

To request a coronavirus test, someone completes a 10-question assessment at imaware.health. Austin-based startup Wheel, Imaware's telemedicine partner, created the online assessment.

Someone is given the go-ahead for testing if, as determined by a licensed health care professional, he or she falls into certain risk categories. For instance, somebody who's been exposed to a person with coronavirus and is over 60 years old would be approved for a test.

If health insurance covers the test or a patient pays for it entirely out of pocket, the test costs $135. (The home-based antibody test will cost about $120 to $125.) Public health agencies, including the Houston Health Department, can authorize a test for someone who can't afford it.

A trained health care professional goes to a patient's home to collect a test sample (by taking a nasal swab for the coronavirus test or drawing blood for the antibody test). A CDC-authorized lab then tests the sample. If needed, a board-certified health care professional can provide post-diagnosis care.

Results of a coronavirus test typically are available within three days. Tuomi says he hopes the results window for the test can be narrowed to between one and two days by the end of April.

"As a patient-advocate company, we are uniquely poised to be part of the testing shortage solution in Texas," Tuomi says in a March 23 release announcing the Imaware coronavirus swab test. "Our online platform, telemedicine partner, and in-home sample collection empower patients to take control of their health and access COVID-19 testing from the comfort of home."

Founded in 2018, Imaware employs 14 people. Others involved in the testing process, such as in-home testing clinicians and telemedicine experts, work for third-party partners. As the company adds to its testing lineup, Tuomi envisions the workforce rising to around 30 to 40 people by the end of 2020.

Earlier this year, Imaware (whose legal name is Microdrop LLC) had concentrated on home-based remote screening and monitoring for conditions like celiac disease and heart disease. But once it became clear that the coronavirus pandemic would be striking the U.S., the company shifted to coronavirus testing and, now, to antibody testing.

Before Imaware jumped into coronavirus testing, Tuomi performed a swab test on himself and realized that it wasn't feasible for anyone to do self-testing. On top of that, evidence surfaced that self-collection of test samples was producing a lot of false-negative results, he says. Subsequently, the federal government blocked self-testing for the coronavirus.

Today, health care professionals handle Imaware's at-home coronavirus testing and will handle the at-home antibody testing. The testing initially launched in Houston then expanded to the rest of Texas.

Tens of thousands of people have done coronavirus self-assessments through Imaware's online tool, Tuomi says. Far fewer people — in the hundreds — have actually fallen into high-risk categories based on the self-assessments and then have qualified for testing.

Tuomi says that as testing capabilities grow, Imaware will be able to accommodate people who fit into medium-risk coronavirus categories. Also, the company plans to offer its coronavirus test in states that neighbor Texas. Imaware hopes to provide its antibody test throughout the U.S.

In tandem with the public testing, Imaware teamed up with Austin-based energy tech startup RigUp to enable daily coronavirus screening at oil and gas jobsites. Imaware and RigUp are piloting the screening with several RigUp customers; they hope it eventually can be supplied nationwide.

"A cornerstone of the Imaware solution is the patient-centric approach offering superior telemedicine care from diagnosis to recovery," Tuomi says.

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Building Houston

 
 

Allterum Therapeutics Inc., a portfolio company of Fannin Innovation Studio, is using the funds to prepare for clinical trials. Photo via Getty Images

Allterum Therapeutics Inc. has built a healthy launchpad for clinical trials of an immunotherapy being developed to fight a rare form of pediatric cancer.

The Houston startup recently collected $1.8 million in seed funding through an investor group associated with Houston-based Fannin Innovation Studio, which focuses on commercializing biotech and medtech discoveries. Allterum has also brought aboard pediatric oncologist Dr. Philip Breitfeld as its chief medical officer. And the startup, a Fannin spinout, has received a $2.9 million grant from the Cancer Prevention Research Institute of Texas.

The funding and Breitfeld's expertise will help Allterum prepare for clinical trials of 4A10, a monoclonal antibody therapy for treatment of cancers that "express" the interleukin-7 receptor (IL7R) gene. These cancers include pediatric acute lymphoblastic leukemia (ALL) and some solid-tumor diseases. The U.S. Food and Drug Administration (FDA) has granted "orphan drug" and "rare pediatric disease" designations to Allterum's monoclonal antibody therapy.

If the phrase "monoclonal antibody therapy" sounds familiar, that's because the FDA has authorized emergency use of this therapy for treatment of COVID-19. In early January, the National Institute of Allergy and Infectious Diseases announced the start of a large-scale clinical trial to evaluate monoclonal antibody therapy for treatment of mild and moderate cases of COVID-19.

Fannin Innovation Studio holds exclusive licensing for Allterum's antibody therapy, developed at the National Cancer Institute. Aside from the cancer institute, Allterum's partners in advancing this technology include the Therapeutic Alliance for Children's Leukemia, Baylor College of Medicine, Texas Children's Hospital, Children's Oncology Group, and Leukemia & Lymphoma Society.

Although many pediatric patients with ALL respond well to standard chemotherapy, some patients continue to grapple with the disease. In particular, patients whose T-cell ALL has returned don't have effective standard therapies available to them. Similarly, patients with one type of B-cell ALL may not benefit from current therapies. Allterum's antibody therapy is designed to effectively treat those patients.

Later this year, Allterum plans to seek FDA approval to proceed with concurrent first- and second-phase clinical trials for its immunotherapy, says Dr. Atul Varadhachary, managing partner of Fannin Innovation Studio, and president and CEO of Allterum. The cash Allterum has on hand now will go toward pretrial work. That will include the manufacturing of the antibody therapy by Japan's Fujifilm Diosynth Biotechnologies, which operates a facility in College Station.

"The process of making a monoclonal antibody ready to give to patients is actually quite expensive," says Varadhachary, adding that Allterum will need to raise more money to carry out the clinical trials.

The global market for monoclonal antibody therapies is projected to exceed $350 billion by 2027, Fortune Business Insight says. The continued growth of these products "is expected to be a major driver of overall biopharmaceutical product sales," according to a review published last year in the Journal of Biomedical Science.

One benefit of these antibody therapies, delivered through IV-delivered infusions, is that they tend to cause fewer side effects than chemotherapy drugs, the American Cancer Society says.

"Monoclonal antibodies are laboratory-produced molecules engineered to serve as substitute antibodies that can restore, enhance or mimic the immune system's attack on cancer cells. They are designed to bind to antigens that are generally more numerous on the surface of cancer cells than healthy cells," the Mayo Clinic says.

Varadhachary says that unlike chemotherapy, monoclonal antibody therapy takes aim at specific targets. Therefore, monoclonal antibody therapy typically doesn't broadly harm healthy cells the way chemotherapy does.

Allterum's clinical trials initially will involve children with ALL, he says, but eventually will pivot to children and adults with other kinds of cancer. Varadhachary believes the initial trials may be the first cancer therapy trials to ever start with children.

"Our collaborators are excited about that because, more often than not, the cancer drugs for children are ones that were first developed for adults and then you extend them to children," he says. "We're quite pleased to be able to do something that's going to be important to children."

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