Saliva test for Autism

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Groundbreaking autism test developed in CNY would diagnose children through saliva

A saliva test designed to help clinicians diagnose autism is expected to be available in the next few weeks. The test detects the levels of 32 small RNA molecules in saliva that its creators say distinguish autistic children from controls.

But some experts are skeptical of the test’s accuracy and value, saying the research it is based on is far too preliminary for clinical use.

The test, called Clarifi, is made by Quadrant Biosciences. The New York-based company has received permission for the test’s use from the U.S. Centers for Medicare and Medicaid Services, the federal agency that oversees lab tests. Once it goes to market, the test is expected to cost $989.

Clarifi is the latest in a string of biological tests for autism developed in the past year. In November [2018], the Wisconsin-based company Stemina debuted a blood test for autism. Another team is in the early stages of developing a urine test for autism.

So the key question is "What is the accuracy of this test?" Where is the research?

Quadrant published some of the research Clarifi is based on in November [2018] in Frontiers in Genetics. In that work, the company found that its test accurately picks up 82 percent of autistic children and identifies 88 percent of children who do not have the condition. But in that study, the researchers used Clarifi in isolation, without a prior screening test.

The company’s promotional material compares Clarifi directly with standard diagnostic tests, saying it is objective and “does not depend on somebody rating someone’s behavior at one particular point in time.” But experts say the data do not support these statements.

The test is based on research in 456 children — 238 with autism, 84 with developmental delay and 134 controls — who visited clinics in New York, Pennsylvania and California between 2015 and 2017.

The researchers analyzed small RNA molecules in the saliva of 372 of the children, including 188 with autism and 71 with developmental delay; some of the RNA is from microbes present in the children’s mouths. (The researchers excluded from the study children with unfilled cavities, dental diseases or upper respiratory infections.) The team measured the amounts of five types of RNA, including microRNA and noncoding RNA.

They used a machine-learning algorithm to rank the molecules by their ability to distinguish the autistic children from the two other groups. They ultimately identified a panel of 32 RNAs. The test analyzes levels of these molecules in each saliva sample.

The researchers evaluated the test in the remaining 84 participants. The test correctly identified 41 of 50 autistic children, 12 of 13 children with developmental delay and 18 of 21 controls.

Source: Doubts precede saliva test for autism, set to be available by July [2018]

this sounds scarey....... idk why but it does