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Environmental Biomarker Start-Up Gains $16M in Early Funds

Human body hair sample

Human body hair sample (Daniel Souza, Wikimedia Commons.

13 Jan. 2023. A new company developing diagnostics for neurological and other disorders based on environmental exposures is raising $16 million in venture funds. Linus Biotechnology Inc. in New York, founded in 2020 and led by researchers at Mount Sinai medical school, is based on studies of the exposome that probes effects of environmental factors to identify precise indicators of disease.

Linus Bio is commercializing technology developed by Mount Sinai researchers who study biomarkers for autism spectrum disorder, a set of related neurological conditions affecting the ability to communicate, learn, and interact socially. Symptoms of these disorders can appear in childhood and affect daily functioning, with repetitive and stereotyped patterns of behavior. According to Centers for Disease Control and Prevention, 1 in 44 children are identified with autism spectrum disorder, occurring across all races, ethnic groups, and social classes, and in four times as many boys than girls.

Diagnosis of autism or these related conditions is based largely on behavioral observations. Research by Manish Arora, professor of environmental medicine and dentistry at Mount Sinai, indicates that the extent of prenatal and early life exposure to certain chemicals and nutrients can affect a child’s development and life-long health in a dynamic way. Among their studies, Arora and colleagues found twin children with higher levels of certain metals in their baby teeth, like lead, and lower amounts of zinc and manganese, were more likely to be diagnosed with autism than their matched twins with normal levels of these metals.

Breakthrough device designation

In 2020, Arora with Mount Sinai colleagues Christine Austin and Paul Curtin — professors of environmental science and data science respectively — licensed their process and founded Linus Bio. The company technology takes non-invasive tissue samples, such as hair, and probes the samples with lasers that the company says keeps molecules intact for analysis. The laser probe, says the company, is combined with with robotics and deep computational techniques to identify biomarkers or indicators of disorders matched to phenotypes or traits. Linus Bio says the tests can be repeated over time to track changes in a condition, as well as early detection.

The company’s first test, called StranDx, is a diagnostic aid currently for autism spectrum disorder. StranDx uses a single strand of hair from infants through adults up to age 21. In Dec. 2021, StranDx received a breakthrough device designation from the Food and Drug Administration for medical devices that provide more effective diagnosis or treatment of debilitating diseases. A breakthrough device developer is given more access to FDA experts during pre-market review, as well as prioritized review of the device. The company says StranDx also received a CE mark, clearing the device for marketing in Europe.

Linus Bio says autism spectrum disorder is just the first condition to test for exposome factors, since early detection is considered crucial, with tests in development or planning for a wider range of diseases. “We chose to focus on autism first for many considerations,” says CEO Arora in a company statement, “an important one of them is the dramatically different trajectory in cases of an early detection and effective intervention. The impact on the patient and the patient’s family can be substantial.”

Linus Bio’s first venture round is raising $16 million led by health care investor GreatPoint Ventures and technology investor Bow Capital, both in San Francisco. Taking part in the round are Divergent Investments and a number of individual investors. According to Crunchbase, Linus Bio raised some $17.5 million in earlier financing.

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