🔒Local biotechs ride roller coaster of emerging COVID-19 at-home tests

The high stakes involved in COVID-19 testing were on everyone’s mind at a Feb. 11 event in Guilford, at the headquarters of biotech startup Detect.

“These devices are going to be seen together as something that changed people’s lives,” said Jonathan Rothberg, founder of Detect and a cluster of other high-profile bioscience companies.

Rothberg gestured at Detect’s existing COVID-19 at-home testing products, then spoke of combining that technology with a flu test — in a form that can be easily reprogrammed for other pathogens. The test would be an affordable, at-home testing solution for future pandemics.

“This is our moon shot,” Rothberg said.

Dignitaries on hand at the event were equally effusive. U.S. Sen. Richard Blumenthal held up Detect’s bright yellow box as he said a version of what every startup wants to hear: “Think of it as the iPhone of infectious-disease testing.”

Diagnostics, or testing products, have moved into the spotlight like never before since the onset of the pandemic, especially home tests that have become crucial to returning to work and school. Quest Diagnostics estimates the growing sector of at-home, consumer-initiated testing will be valued at more than $2 billion by 2025.

Connecticut is home to various startups and other companies — including Detect, Wren Laboratories, Saliva Direct, Sema4 and Genesys Diagnostics — that have tried, or are trying to compete in the space, which has proven challenging and unpredictable based on huge swings in demand, supply chain issues and other pressures.

Breakthrough opportunities

The Detect event in February was prompted by the company winning a contract worth up to $30 million from the federal Biomedical Advanced Research and Development Authority for its home-test products. With the funds Detect plans to leverage its virus-detecting technology to create a combination rapid at-home test for both COVID-19 and influenza variants.

Blumenthal, U.S. Rep. Rosa DeLauro and other notables gathered for the event at Detect’s campus at 351 New Whitfield St., in Guilford.

For Detect, the COVID-19 pandemic has provided opportunities both for breakthroughs and a higher profile. DeLauro and Blumenthal, who hold powerful posts in Washington, D.C., both pledged to do whatever they could to ensure continued funding for innovations by Rothberg, who launched Detect in March 2020. The company joined his other high-profile ventures including Butterfly Network and Hyperfine.

“This breakthrough is a matter of national security, it's a matter of economic security,” DeLauro said of Detect’s technology. “People need to go back to work and back to normal.”

On the commercial front, Detect did not disclose sales numbers for its current test, available as a starter kit for $75 at the company’s website, a discount from the usual $88. The kit consists of a single-use test and reusable “hub” that reads and reports the results of a nasal swab test.

Rothberg said his team was able to keep up despite a surge in orders due to the omicron variant.

“Obviously with omicron the demand skyrocketed beyond anything we had imagined. However, we had a team that could meet the challenge,” he said. “We designed this to be scalable so we're meeting demand but truthfully demand is way beyond anything we would have imagined.”

Riding the roller coaster

Shifts in demand have challenged diagnostics companies including major national biotech players like Abbott Laboratories, maker of the ubiquitous BinaxNOW home tests. As of last summer, analysts were predicting downturns for Abbott and other diagnostic firms like Qiagen and Quidel due to the ebbing of the pandemic’s first phase.

"Describing the ups and downs of COVID testing for Abbott during the pandemic as a 'roller coaster' does not fully capture the experience,” Credit Suisse analyst Matt Miksic told industry publication Medtechdive.com.

Political considerations can add to the roller coaster effect, as in the case of another Connecticut biotech, Stamford-based Sema4. Once one of the state’s biggest partners for in-person COVID-19 testing, Sema4 decided to quit the business late last year. That was around the same time when questions arose about venture capital investments in the company by Gov. Ned Lamont’s wife, Annie Lamont.

Fifteen COVID testing sites across the state were left without a contractor after the withdrawal of Sema4, the state’s second-highest paid testing contractor as of the end of 2021. Among the companies that stepped in to take over Sema4’s locations were Wren Laboratories, Quest Diagnostics, Progressive Laboratories and Genesys Diagnostics, headquartered near East Lyme.

Wren Laboratories of Branford rolled out its own home test in February 2021, offering a PCR-quality accuracy with easy-to-use and more comfortable saliva sampling. Wren’s test allows users to spit in a tube, combine that saliva with a proprietary buffer solution, then ship off the sample for results within 24 hours.

But Wren’s small size played a role in a setback for the company when it offered COVID-19 testing at New Haven’s 60 Sargent Dr. drive-through site, located just off major highways in the Long Wharf district.

Wren Laboratories signed a deal with the state to provide its innovative saliva tests at 60 Long Wharf and on the New Haven Green in late 2021, just before the omicron variant hit with full force, causing COVID infection rates to explode and testing demand to skyrocket.

Facing staffing shortages due to infections along with shortages of key supplies, Wren was forced to cut its number of daily testing slots from 300 per site per day to 150 during the holiday season. Lines for testing stretched down the block, like they did at many testing sites statewide, and complaints multiplied.

By mid-January, the state had replaced the Branford biotech with Saliva Direct, a Yale School of Public Health startup that partners with Yale’s pathology labs to process tests.

Saliva Direct took over the two Wren sites on Jan. 17 — just in time for in-person testing demand to fall off a cliff due to declining infection rates and a huge rollout of at-home test kits.

At Detect in Guilford, Rothberg said he’s ready to face the challenges of the diagnostics market for COVID-19, its new variants or whatever bug comes next. His team is using their experience making and marketing medical products like Butterfly Network’s bedside ultrasound and Hyperfine’s portable MRI to optimize manufacturing and explore international markets.

As for supply chain issues, Rothberg has an answer. Detect makes its own swabs and other supplies.

“We don’t call them issues, we call them challenges, and we’ve conquered them by creating all of our own components,” he said. “You have to reinvent the supply chain."