LetsGetChecked Hit with Class Action Over Allegedly ‘Useless,’ ‘Inaccurate’ Lyme Disease Tests

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LetsGetChecked faces a proposed class action that alleges the health diagnostic company’s at-home Lyme disease tests are “shockingly” inaccurate.

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The 30-page lawsuit was filed by TruthCures, a nonprofit committed to education about Lyme disease, and claims LetsGetChecked has falsely marketed its direct-to-consumer finger prick tests as a reliable and effective way to receive a comprehensive Lyme disease diagnosis.

What consumers don’t know, the case alleges, is that LetsGetChecked’s product has a very high chance of producing an erroneous diagnosis, which may prevent a consumer from seeking medically necessary treatment and lead to serious health complications.

The suit explains that Lyme disease, one of the most common vector-borne diseases in the United States, develops when a tick bite transmits certain strains of bacteria known collectively as Borrelia burgdorferi sensu lato. Although dozens of bacterial strains cause Lyme disease, which is contracted by over one million Americans each year, LetsGetChecked’s product can detect only one type of disease-causing Borrelia bacteria in a test-taker’s body, the complaint charges.

Per the filing, LetsGetChecked fails to inform consumers that its tests cannot provide comprehensive results due to its inability to detect all Lyme disease-causing Borrelia strains.

Moreover, the complaint contends that LetsGetChecked fails to disclose to consumers that, according to guidance from the Centers for Disease Control and Prevention (CDC), Lyme disease must be diagnosed by a healthcare provider based on physical symptoms.

“Based on this omission, consumers erroneously (and tragically) believe they can rely solely on the Defendant’s laboratory test to diagnose Lyme disease,” the case summarizes, claiming that the product is essentially “useless” since consumers must pay for a doctor’s visit and another doctor-prescribed test to obtain a proper diagnosis.

As such, a report from the U.S. Food and Drug Administration (FDA) states that for early-stage infections, a positive test result produced by the defendant’s test is correct only 58 percent to 85 percent of the time, the suit relays. Concerningly, the FDA warns that a negative result produced by LetsGetChecked’s product “should not be used to exclude Lyme disease,” the complaint says.

The lawsuit alleges that LetsGetChecked actively conceals these pertinent facts because it knows that no consumer would buy its Lyme disease tests if they knew that the product “is no better than a coin flip for a positive diagnosis” and “utterly useless for a negative diagnosis.”

As a result, the case says, consumers who use LetsGetChecked’s Lyme disease tests may incorrectly believe they are healthy after receiving a false negative, causing them to forego or delay seeking medical attention.

When left untreated, the illness can quickly spread throughout the body and cause “debilitating and often permanent” physical afflictions, including crippling fatigue, cardiac arrest, cognitive dysfunction, chronic pain and more, the complaint relays.

The lawsuit looks to represent all persons or entities who purchased LetsGetChecked’s Lyme disease test for consumption by themselves, their families, or their members, employees, insureds, participants or beneficiaries, and not for resale.

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