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Quadrant Laboratories Launches At-Home Gene Panel for Autism-Related Conditions


NEW YORK – Quadrant Laboratories has pivoted from COVID-19 testing to autism spectrum disorder (ASD) and intellectual disability (ID) with the recent approval of its gene panel for ASD-related conditions by the New York State Department of Health (NYSDOH).

Quadrant Labs launched in 2021 in response to the COVID-19 pandemic and, along with Quadrant Life Sciences, is a subsidiary of Syracuse, New York-based Quadrant Biosciences.

Quadrant Labs is the company's clinical laboratory and focuses on molecular genetics and assays that support neurodevelopmental disorders, while Quadrant Life Sciences is the company's R&D outfit that helps develop multiomic assays for Quadrant Labs. Quadrant Life Sciences also operates the enterprise's 50-state pediatric contract research organization and maintains the company's biobank.

Quadrant Life Sciences already had experience working with RNA-based molecular testing prior to the pandemic, and Quadrant Labs CEO Bryan Greene said that the transition to COVID-19 testing when founding Quadrant Labs "was pretty natural."

However, he added that "COVID laboratory testing was not going to be a sustainable business model in the future."

Quadrant Labs' new ASD genetic test panel, which is available in all 50 states, includes 285 genes with known relationships to conditions often associated with ASD and ID, such as gastroesophageal reflux, generalized hypotonia, and seizures, as well as gene variants associated with underlying causes of ASD/ID.

The exact genetic causes of ASD remain unknown, and estimates of the proportion of cases that might result from genetic variants range from 20 percent to 80 percent.

Despite this uncertainty, Lia Boyle, a physician-scientist in a genetics residency at the University of Michigan, explained that testing for ASD-associated variants can provide meaningful and actionable information to physicians trying to decide how best to care for their patients.

"The current standard of care recommends anyone with an ASD diagnosis be offered genetic testing," she said. "Panel tests can make accessing a genetic diagnosis more accessible for patients, and you can absolutely get actionable results. [For example], a child with autism who has it in the context of fragile X syndrome would have different medical management from someone who has Rett syndrome."

Panel testing, as opposed to larger whole-exome or whole-genome sequencing assays, also plays an important role for non-geneticist medical professionals who order such tests, she said, as there are too few geneticists to see all the patients who would benefit from genetic testing.

"I think it's very important a doctor only order a test if she knows how to talk to her patients about possible results," Boyle said, adding that it's better for a patient to get an appropriate panel sent by a non-geneticist than to wait a typical 12 to 18 months for a geneticist.

Quadrant Labs contracts with genetic counseling firm DNAvisit to provide counseling to physicians and patients. Greene said that this arrangement provides access to a network of "eight to 10" genetic counselors that together provide coverage to all 50 states.

ASD diagnosis rates have been rising over time. The US Centers for Disease Control and Prevention, for example, tracked a rise from one in 150 children in 2000 to one in 36 in 2020.

Along with that rise, numerous companies have developed genetic panels to aid in the diagnosis of ASD or to diagnose and guide therapy for ASD-associated disorders. Companies within this space include GeneDx, Prevention Genetics, Blueprint Genetics, Fulgent Genetics, and Paragon Genomics, among others.

Quadrant's 285-gene panel includes more genes than many competing panels, which tend to range from 75 genes, as in the case of Blueprint Genetics, to 170 genes, as with Prevention Genetics. Prevention Genetics, however, also offers a wide-ranging 2,527-gene panel for ASD, ID, and epilepsy, which includes exome-wide copy number variant (CNV) detection.

Greene said that Quadrant's ASD panel better optimizes both comprehensiveness and specificity and that it especially differentiates itself by requiring saliva, rather than blood.

Not only is saliva easier to collect than blood, Greene said, but it makes at-home sample collection possible.

"We can ship these kits directly to the families' houses where they can sample their child without having to leave the house which is huge because we're talking about a population that has a lot of sensory issues," Greene said.

Blood draws and needles are a problem for any child, he continued, but can be especially problematic for autistic children, who are more likely to have social anxiety resulting in more difficult interactions at a doctor's office or in a clinical setting in general.

"Oftentimes," he said, "the stories we hear are of parents pinning the kids down to get these blood draws, and we [thought], there's got to be an easier way. DNA is in saliva, [so] why can't we do it this way?"

Saliva samples are sent to Quadrant Labs' CLIA-certified and CAP-accredited lab for targeted panel sequencing on an Illumina platform, with results returned to a patient's physician approximately four to six weeks after sample receipt.

Quadrant Labs' ASD panel received NYSDOH approval on March 18 and is covered by the Centers for Medicare and Medicaid Services. Last year, the company also received NYSDOH approval for its fragile X syndrome test.

"We've primarily focused on Medicaid," Greene said, "because [roughly] half the children in the US are covered by Medicaid plans."

As of 2023, the Medicaid program estimated that approximately 46 percent of children in the US were enrolled in Medicaid and Children's Health Insurance Programs.

Greene said that the company has also had "some good success" in getting private payor coverage and that while securing prior authorizations for ASD/ID genetic testing is occasionally challenging, "overall we're seeing good success there."

"We have found very few people who would be exposed to [paying] the cash price on this," he said, which is "in the $2,000 to $3,000 range."

Quadrant Labs has already begun processing its first batch of almost 100 samples.

"We've done the library prep, and we've sequenced our first run," Greene said. "Now, we're [doing] the data analysis, and we'll be resulting out that first batch later this week, with the rest of those 100 samples [coming out] throughout early April."