Infrawear Obtains FDA IV.D Status Alongside Exclusive Deal with Genesprint for Worldwide Distribution of PCR Swab and NCOV-19 IGM/ IGG Antibody Test Kits for COVID-19

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Company Supplying Tests and PPE to 100+ U.S. Hospitals, Government Agencies, and Corporations with CLIA Certified Laboratories and/or with Authorization to work with CLIA Labs.

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Infrawear LLC, the go-to resource for medical professionals, hospitals, first responders, and companies with critical PPE and COVID-19 testing and antibody kits, today announced that it has obtained its IV.D status from the FDA. As an FDA IV.D (4D) listed and registered Class 2 medical device importer, the company is leveraging its deep operational supply chain experience to source and import critical PPE and COVID-19-specific tests as the exclusive distributor and partner for Genesprint Group Ltd., a leading research and manufacturing company for on-site antibody diagnostic kits for various infectious disease. As their exclusive worldwide distribution partner, Infrawear is able to sell their high-demand, PCR Swab and NCOV-19 IGM/ IGG Antibody Test Kits for COVID-19. Additionally, the FDA just listed Genesprint’s serology antibody test on their emergency notification list, enabling Infrawear to to distribute to anyone who has a CLIA lab or is certified to work with a CLIA lab. Additionally, they’ve increased capacity and can get tests to most doctor’s offices with NEXT DAY delivery.

"We’re amazed at what our agile team has been able to accomplish to help hospitals and medical professionals in the U.S. in just a short amount of time,” said Rachael McCrary, co-founder and President of Infrawear. “Our team has such deep supply chain experience and operational expertise that, after seeing the immediate need, we were quickly able to tap into our existing relationships and create an effective, affordable and, most critically, a reliable solution to aid in the fight against COVID-19. We’re thankful for our partnership with Genesprint, who knew how nimble we could be and didn’t go with a large corporation for distribution, due to our reputation for being able to get things done quickly and effectively.”

Infrawear has an established history of having the deepest level of sourcing and shipping expertise and supply chain know-how. Since the COVID pandemic, the Company has already built new relationships with more than 100+ hospitals, government agencies, and corporations across the U.S., in less than four months’ time. Infrawear is rapidly providing top-quality, high-demand medical supplies, tests and PPE to clinical laboratories or to healthcare workers for point-of-care testing covered by a laboratory’s CLIA certification for high-complexity testing, with ease and efficiency.

In partnership with Genesprint, Infrawear is one of the few companies that to outpace demand by easily sourcing and distributing these much needed, life-altering tests rapid tests for COVID-19. There are two types of tests offered: the PCR Swab Test (patent-pending) for COVID-19 virus testing, and the NCOV-19 IGM/ IGG antibody test kit and Nucleic Acid Collector that tests for COVID antibodies past and present. Testing is key in getting America back to work and back to normalcy, and Genesprint tests are known for their high-accuracy, accessibility and affordability. Where other large testing companies have reportedly only received 50,000 tests per month, Genesprint can produce 20 million per month. Their tests are available in the U.S. through Infrawear now, with shipments coming in daily for medical professionals to deliver antibody test results within 15 minutes and COVID-19 test results within three hours’ time.

“We’re making mass screening more accessible to those in need,” said Jonathan Sweetser, CTO at Infrawear. “The beauty of working with Infrawear is that physicians, medical professionals, and any company with medical staff don’t have to have to go through the bureaucracy or red tape to simply get needed supplies in-hand, without the hassle. By providing ease of access to the high-demand supplies, putting them in hands of those in need for today’s ever and rapidly-evolving medical demands, Infrawear is helping those in need at a much faster rate than large testing companies.”

Infrawear has experienced growth by more than 100% MoM. The Company’s ability to quickly provide effective and accurate tests at U.S. laboratories and hospitals is expected to improve and help flatten the infection curve.

About Infrawear, LLC
Infrawear, LLC is the go-to resource for medical professionals, hospitals and first responders for critical PPE and COVID-19 testing and antibody kits. We have a passion for innovation and an established track record for getting things done quickly and efficiently. As an FDA IV.D (4D) notify listed and registered Class 2 medical device importer, the company leverages its deep operational supply chain experience to source and import critical PPE and supplies such as N95 masks, gowns, testing kits and antibody tests. As the exclusive distributor and partner for Genesprint Group Ltd. we provide access to their sought after rapid COVID-19 tests, including NCOV-19 IGM/ IGG antibody test kit as well as its PCR Swab Test for COVID-19. Infrawear is also the parent company of RxBra, which manufactures proprietary vertical, and post-surgical garments to plastic surgeons. Our company is recommended by the American Hospital Association and is well-known for providing ease of access to high-demand supplies, putting them in the hands of those in need for today’s ever and rapidly-evolving medical demands. Infrawear LLC is a US-based company headquartered in Los Angeles, with offices in New York and Ohio. Learn more by visiting: Infrawear.com

About Genesprint Group Ltd
Genesprint Group Ltd is a Hong Kong based testing company founded by Dr. Paul Tam, with their lab and research team being led by Dr. Sherman Fung, Dr. Chi C. Wong. They have been developing research and manufacturing for on-site antibody diagnostic kits for various infectious diseases for more than three years. Recently, they launched the rapid tests for COVID-19, which can deliver results within minutes and provide mass screening to the general population.

About the PCR Swab Test for COVID-19
The Genesprint PCR Swab is patent-pending in Hong Kong and is only available in the U.S. through Infrawear, LLC. The test is made of nylon and is optimized for specimen collection. GP swab relates to the field of swabs, in particular to a swab optimized for specimen collection. In one embodiment, the swab comprises a stem having two ends at opposite sides along its longitudinal axis, and having a tip portion defined as an area proximate and terminating at an end of said stem; a layer of fiber strands attached to and covering said tip portion, said fiber strands are attached to said tip portion at a substantially perpendicular angle against said tip portion; wherein said layer of fiber strands forms a hydrophilic open fiber morphology and facilitates absorption of a fluid through capillary effect; said layer of fiber strands further optimizes elution of a specimen contained in said fluid. In a preferred embodiment, the nylon fiber strands are electrostatically charged. This swab has a better performance with liquid intake and release compared to existing swabs, such as cotton wound swabs.

About the Antibody Test for COVID-19 - NCOV-19 IGM/ IGG antibody test kit and Nucleic Acid Collector
Our sensitivity can detect as early as 2.5 days of exposure. The Serology Antibody finger prick test when compared to a PCR test:

  • Accuracy: 98.75
  • Sensitivity: 98.75
  • Specificity: 98.74
  • We have 85% accuracy on early onset

PRESS CONTACT:
Nicole Rodrigues
NRPR Group
(650) 815–5069
Nicole@nrprgroup.com

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Jessica Gilbert
NRPR Group
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