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Arul Chinnaiyan and Yashar Niknafs

The Headlong Growth of LynxDx

First it became Michigan's largest Covid tester. Now it's going after prostate cancer

by Ken Garber

From the August, 2021 issue

Biotech startup LynxDx moved into its new lab in February 2020 with just four employees: CEO Yashar Niknafs, a chief operating officer, a lab director, and a research scientist. They were developing a diagnostic test for prostate cancer.

"We were barely settled--there was still drywall being put out--when the pandemic came," recalls Niknafs. The lab, tucked into a quiet corner of Jackson Plaza across from Ann Arbor Indoor Golf, abruptly shifted to Covid-19 testing instead.

They went on a hiring spree, bought lab equipment, and adapted a saliva test from Yale University that was more user-friendly than the standard nasal swabs. Lynx contracted with the U-M to test its students and with St. Joe's to test patients ahead of hospital visits. But most Ann Arborites know it for its drive-thru tent in the parking lot of the 2|42 Community Church on Wagner.

That tent proved essential during last winter's surge, says Juan Marquez, medical director of both the 'Washtenaw and Livingston county health departments. "We didn't have the staff to do ... drive-thru testing," he says. "Most of our clinical team was really doing case investigation." The company also set up pop-up test sites for the county in neighborhood hot spots.

Marquez sometimes called Niknafs directly for the results, including the critical "cycle threshold value," which distinguishes true cases from old infections. "When you're working with a natiownal lab, it's pretty challenging to even get on the phone with somebody who can provide that information, if they're willing to do so at all," says Marquez. But such confirmation can be critical. "For example, if it's a student, and we're not entirely sure if it's a false positive or a true positive, that could mean quarantining forty or fifty students or not."

Some facilities hired LynxDx to retest individuals diagnosed with Covid by automated tests from other labs, and it sometimes reversed false positives. "We've actually had at least two sets of human eyes look at every single sample that

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we've ever reported," Niknafs says. And ... we run all of our positives at least twice."

That wasn't easy. "At our peak we were doing 4-6,000 samples a day," says Niknafs. "For quite some time we were the largest tester in the state."

Though individuals paid nothing out of pocket, Lynx billed their insurance companies or the federal government. "I don't think anyone thought that they would make as much money as they did, with adding in the Covid testing," says Patti Glaza, managing director at Invest Detroit (ID) Ventures, an early investor in the company.

The pandemic pivot "really has given the company a nice position on which to grow," Glaza adds. She calls Niknafs "an incredibly smart, hardworking, and thoughtful entrepreneur." And Lynx now has more than 140 employees.

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A native of Akron and a Case Western grad, Niknafs came to Ann Arbor in 2011 for the 'U-M's MD-PhD program. After a few years of medical school, he joined the lab of U-M molecular pathologist Arul Chinnaiyan, working to uncover numerous genes that get turned on in prostate cancer.

"At some point during that journey I became a little bit disenchanted with practicing medicine," he says, "and had been having conversations with Arul" about starting a company.

Chinnaiyan is a star cancer researcher and a serial entrepreneur, having cofounded at least seven U-M spin-off companies. His lab also contributed two genes to Decipher, a widely used genetic test that helps newly diagnosed prostate cancer patients make treatment decisions. He launched LynxDx in 2019 with Niknafs (who completed his doctorate in 2017) and U-M urologist Jeff Tosoian.

The company's first proprietary product will be a urine test called MyProstateScore (MPS). Chinnaiyan and U-M pathologist Scott Tomlins (now at Strata Oncology, another local biotech) developed it in Chinnaiyan's U-M lab after discovering, to their surprise, that two genes fused together drive more than half of all prostate cancers. The MPS test looks for the presence of that fused gene and measures another prostate cancer marker.

There's already a standard blood test for prostate cancer that measures a "'prostate-specific antigen." But because PSA alone is a poor predictor of cancer, men with high PSA levels may undergo biopsy after painful biopsy, looking for a cancer that isn't there.

Combined with PSA, the MPS test can detect 97 percent of prostate cancers. With so few false negatives, patients with a negative result can forgo a biopsy even if they have elevated blood PSA--sparing them from "PSA hell."

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Niknaf's next goal is to roll out MPS nationally. The U-M has quietly offered the test since 2015, but "there was no commercial effort really," he says. "All of the ingredients you need to really get a test used nationally and at a large scale--a lot of that effort is just beyond the scope of what a university can do."

LynxDx is working on getting insurers to cover the prostate test, so patients won't have to pay out of pocket. And it is scaling up for a national rollout. Although similar prostate tests are already widely available, MPS appears to perform better, based on trial results reported in the Journal of Urology in February.

Without a direct comparison, it's hard to know for sure. "It would be great to have head-to-head data, [but] there's very little of that," says U-M urologist Todd Morgan.

Glaza was convinced enough to invest in the company. Already having rights to an existing commercial product helped. For a startup company, "that can be a failure point, and it certainly was an incentive in terms of writing an early check," she says, as part of LynxDx's $925,000 round of seed funding that closed in January 2020. The company has since secured a $2 million grant from the National Institutes of Health.

But the big lure for investors is the prospect of a test that would be "disruptive in the prostate testing market," in Glaza's words. The MPS test "was their beachhead," she says, "but not their ultimate goal ... they have the second platform that's coming to market, that if all goes right, replaces the PSA test."

Niknafs is more circumspect but foresees a test that doesn't just diagnose prostate cancer when it's there--something MPS does very well now--but also avoids false positives, a current shortcoming of all such tests. That would make testing a lot more useful to urologists and their patients.

Lynx has licensed more than a dozen marker genes for prostate cancer discovered in Chinnaiyan's lab. "There is an intention to use those genes," says Niknafs, but "we don't yet know what that test will be."

In the meantime, he says, there are no plans to discontinue Covid testing, despite the county's high vaccination rate and plunging case load. The drive-thru Covid tent on Wagner still sees traffic, often kids who need to show a negative test to participate in team sports.

The contract with St. Joe's recently ended, but "we'll be testing the University of Michigan as long as they want to continue to test," Niknafs says. That's also true of the 107 Detroit public schools where LynxDx teams have been testing students once a week while school is in session.

Glaza credits Lynx's success with Covid testing for speeding the company along. The company recently hired a chief commercial officer and a chief reimbursement officer--"folks with experience and titles that you normally cannot hire at this stage," she says.

While Covid delayed their prostate work, "I don't think they've lost momentum, because Covid just took the attention away from everything," Glaza says. "The key now for them is to refocus."     (end of article)

 


 
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