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Hardy Diagnostics distributing rapid test for coronavirus

By   /   Thursday, March 26th, 2020  /   Comments Off on Hardy Diagnostics distributing rapid test for coronavirus

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Santa Maria-based Hardy Diagnostics is distributing a rapid test for coronavirus.

Hardy said the test takes 15 minutes, doesn’t need to be processed by a lab, and it has clear, easy-to-read results.

The test can use either a blood, serum or plasma sample, a departure from current testing methods which use swabs from where the nose meets the throat to collect samples that are then tested for the virus.

A faster and simpler test doesn’t mean the general public will be able to get their hands on it, though. Hardy said the test is meant to be used by clinical laboratory personnel, and that a molecular diagnostic test should still be used to confirm coronavirus in a patient.

“This test will be useful in identifying asymptomatic and mildly symptomatic carriers,” said the company’s website. “It will also be helpful in identifying persons who were infected by the virus previously but may not have been properly diagnosed.”

Hardy Diagnostics, which also makes medical devices, isn’t making the coronavirus tests. The company is distributing them for Autobio Diagnostics, a publicly-traded microbiology medical device producer based in Zhengzhou, China.

“We are incredibly proud of the work our partners in China have accomplished,” said Andre Hsiung, director of technical services at Hardy Diagnostics, in a news release. “Because Autobio quickly developed this technology and because the FDA allowed Emergency Use Authorization, we will be able to more effectively leverage our sales network to get this product out to where it is needed the most.”

Hardy Diagnostics is also a distributor for COPAN, an Italian laboratory products manufacturer. One of the products COPAN makes is a viral collection medium, which health care workers use to collect samples from people being tested for COVID-19.

While the viral medium isn’t part of any test for coronavirus, the substance keeps the virus alive so it can be tested. Hardy Diagnostics has more than three million units of the collection medium on back order.

The supply is severely limited because of Italy’s own coronavirus crisis.

“We get some in, but it’s never enough,” said Jay Hardy, president of Hardy Diagnostics.

The company recently got a large shipment of the medium, which the military helped it secure and bring to the United States, but Hardy Diagnostics is doing more to help the response. The company is reviving its own FDA-approved viral medium, which it discontinued making because of a lack of interest.

Since Hardy started making its own, the company has sold thousands of units, and it’s pouring resources into producing as many as possible. Hardy said the company wants to make upward of 10,000 units of viral medium per day, and that th factories are running day and night to produce as much as possible.

“We’re cranking them out as fast as we can,” Hardy said.

In order to make that many supplies, the company is seeking governmental assistance to effectively quadruple its output. Hardy Diagnostics has two facilities, one in Santa Maria and one in Springboro, Ohio. The company would like to buy additional machines for both facilities, which Hardy said would help it meet a nationwide shortage.

The tri-county region is home to many companies working in biotech, and other companies are ramping up their production to meet skyrocketing demand for medical devices.

Laritech, a circuit board manufacture in Simi Valley, has set aside part of its 77,000-square-foot facility to manufacture medical device parts for InTouch Health, a telemedicine company based out of Goleta.

The device Laritech makes parts for is InTouch’s Lite 4 telehealth system, which allows doctors to provide patients with high-quality virtual care.

In a time when all public health systems are preparing for what they see is the eventuality of being overwhelmed with coronavirus patients, telehealth helps doctors see patients who may need limited help from a distance, allowing people to access medical care and advice without potentially exposing themselves to the disease.

Telehealth solutions also preserve precious time and resources for more critical cases, experts said.

Laritech is prepared to hire on additional people in a temporary role to help produce those devices.

Terry Gonzales, vice president of operation and sales at the company, said in an email that Laritech is supporting InTouch Health “anyway we can to get their telehealth solutions out to the hospitals.”

• Contact Amber Hair at

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About the author

Staff Writer at Pacific Coast Business Times, Inc.

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