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NYC Selects Aria for Sample Collection Kits But Continues to Face Coronavirus Testing Challenges

NEW YORK ─ Responding to a lack of testing supplies, New York City Mayor Bill de Blasio this week said the city government will purchase 50,000 SARS-CoV-2 test collection kits per week from Aria Diagnostics, a little-known company in Indianapolis, Indiana.

During a webcast press conference on Tuesday, de Blasio said that New York City's government is also bringing together a group of industry stakeholders to begin making sample collection kits.

Mayor de Blasio said the deal with Aria Diagnostics was facilitated by his personal connection with Carmel, Indiana Mayor James Brainard. The need to reach out to another state for help is reflective of states being left to fend for themselves by the federal government as they try to ensure enough tests are available for detecting SARS-CoV-2, the virus that causes COVID-19, he said.

Starting in a few weeks, companies, universities, and other entities in New York will begin producing 50,000 collection kits per week for testing, de Blasio said. "Add that to the 50,000 a week from Aria Diagnostics [and] we'll have 100,000 full test [collection] kits per week that New York City can rely on, 400,000 per month, and that's just the beginning."

The collection kits have three components ─ a nasopharyngeal swab, a viral transport medium that preserves the swabs and sample, and a tube with a screw top.

New York-based hospitals and reference labs are expected to use them to supplement kits they are already using to run tests for SARS-CoV-2 on their RT-PCR platforms, Zak Khan, a partner at Aria Diagnostics, said in an interview.

Khan founded Aria Diagnostics five years ago to serve as a toxicology lab for doctors ordering tests through Carmel-based Surgery Center Development. He is CEO of Surgery Center Development, a firm that consists of surgery centers whose clinicians need testing.

Aria recently began testing for SARS-CoV-2 from its CLIA-certified, CAP-accredited laboratory in Indianapolis. The company uses Thermo Fisher Scientific's assay and platform that has received US Food and Drug Administration Emergency Use Authorization.

Though Aria does not anticipate receiving orders from New York for testing in its lab, the firm has available capacity to provide testing if needed. The lab is providing results in 24 to 48 hours from the time of testing, and New Yorkers could expect about the same time to result if samples are shipped overnight, Khan said.

The test collection kits for New York can be used with current approved RT-PCR platforms, Khan said. "We wanted to make sure they are compatible with platforms operating in the labs that New York is currently using for testing," he added.

Aria began making collection kits after hearing about diagnostic supply chain shortages in New York. The firm had begun assembling kits for its own lab. "We were able to find the raw components that made up the kits but were having a tough time finding fully assembled kits," Khan said.

The company conducted a feasibility study to ensure that the kits led to accurate test results, and it was getting ready to order supplies when it heard about the shortages in New York.

Aria sent 35,000 nasopharyngeal swabs ─ the component most urgently needed ─ on Monday and an additional 15,000 the following day. Going forward, the firm will supply fully assembled collection kits.

In its own lab, Aria conducts testing for SARS-CoV-2 for people in Indianapolis. People paying with cash upfront can come to the lab to be tested after arranging an appointment, but people who use insurance for reimbursement need a doctor's referral because of payor requirements, Khan said.

Aria Diagnostics had recently experienced SARS-CoV-2 reagent shortages for an undisclosed platform, but it moved those tests to its Thermo Fisher platform, which has the capacity needed to meet demand for its patients. Because several RT-PCR testing platforms have recently received FDA Emergency Use Authorization, reagent availability is less of a problem, Khan said.

However, in the press conference this week, de Blasio noted that having enough collection kits is just one tricky component of testing for SARS-CoV-2. "[A] whole other part of the equation is [to continue] to increase the capacity in labs to process these tests and give us the answer person by person, positive or negative," he said.

The New York City mayor's office did not respond to questions about the availability of testing.

However, in an interview on CNN Wednesday, New York Governor Andrew Cuomo described his dissatisfaction with the level of support for New York from the federal government and echoed some of de Blasio's frustration.

Cuomo noted that that states are being made to bid against each other for scarce resources and that the federal government is washing its hands of issues associated with testing. Cuomo said there are not enough vials, swabs, or testing machines, and labs do not have the capacity to meet testing demand.

"The major diagnostic test manufacturers are probably not producing as much reagent as their customers say they need, and there is no question, there is a shortage of collection kits," Robert Boorstein, medical director for oncology and esoteric testing at Brooklyn, New York-based Lenco Diagnostic Laboratories, said in an interview.

What is unclear about the collection kits expected in New York, he said, is whether laboratorians will need to revalidate them with their laboratory testing systems. Boorstein said he is awaiting a response about that from New York City's government.

"If you have to revalidate the collection kit, that's not a trivial matter," said Boorstein, whose lab on Wednesday rolled out serology tests for antibodies to the virus. Validation is doable, but it takes time, Boorstein said.