Inside Indiana Business

CARMEL – A life sciences startup has announced plans to grow its central Indiana operations. The Indiana Economic Development Corp. says Carmel-based 3Oe Scientific LLC will invest $500,000 to accelerate the growth of its patented hand sanitizing system technology and create up to 30 jobs by the end of 2022.

3Oe says its aqueous ozone hand sanitizing device infuses ozone molecules into water, which kills pathogens such as viruses, bacteria and spores naturally without soaps or chemicals. The company says users place their hands into the device for a few seconds allowing all surface areas of the hands to be covered with a steady stream of aqueous ozone.

“The technology is expected to revolutionize the healthcare and public health sectors in areas of efficacy, compliance and tracking,” said Dr. Tom Foust, founder and chief executive officer of 3Oe. “As an innovation-centric tech company, we look forward to not only positively impacting our community with our products but also growing our workforce here in Indiana as we expand and scale.”

The IEDC says the company has partnered with local hospitals and schools to beta test the technology and plans to submit it for approval from the U.S. Food and Drug Administration later this year.

3Oe plans to begin hiring for the new jobs later this year. The company says the positions will to come with salaries above the state average wage.

“Thanks to innovative life sciences companies like 3Oe, Indiana ranks as one of the five most concentrated life sciences states in the U.S., contributing $77 billion to our state’s economy,” said Indiana Secretary of Commerce Jim Schellinger. “We’re excited 3Oe is developing its game-changing product here, while simultaneously investing in Indiana’s workforce and creating good jobs for Hoosiers.”

The IEDC has offered 3Oe Scientific up to $600,000 in conditional tax credits, which the company will not be eligible to claim until Hoosier workers are hired for the new jobs. 

Inside Indiana Business

WARSAW – A Warsaw-based orthopedic product development company has announced plans to expand operations. Nextremity Solutions Inc. says it will invest more than $4.5 million to transform a shell building at the Warsaw Technology Park into its headquarters and create up to 111 jobs by the end of 2024. The Indiana Economic Development Corp. says the building will allow the company to consolidate its product development and manufacturing operations under one roof.

Nextremity Solutions is partnering on the project with West Hill Development, which originally developed the shell building.

“This is such an exciting time for our team at Nextremity Solutions as we expand our capabilities to create, manufacture and deliver innovative solutions to our strategic alliance partners and to other orthopedic companies,” Rod Mayer, chief executive officer of Nextremity Solutions, said in a news release. “The shell building provides the ideal location for us as we create a synergistic partnership with Lakeland Technology going forward.”

Construction is expected to be complete by April 2021 and the company plans to begin moving employees to the new facility before the end of this year. Nextremity Solutions currently employs 24 workers and says it will begin hiring for development and manufacturing positions as needs arise.

The expansion comes two months after Nextremity Solutions acquired Lakeland Technology Inc., a contract manufacturer for the medical device industry also located in Warsaw. Financial terms of the deal were not disclosed.

The IEDC has offered Nextremity Solutions up to $1.6 million in conditional tax credits and up to $100,000 in training grants, which the company will not be eligible to claim until Hoosier workers are hired for the new jobs. The Warsaw Redevelopment Commission and the Warsaw Common Council will consider additional incentives.

On Wednesday, Governor Holcomb announced that Indiana has earned the ability to move forward to stage 3 of the Back on Track Indiana plan, two days earlier than previously planned.

Cass, Lake, and Marion counties, which were hit hardest by the coronavirus, will be eligible to enter stage 3 on June 1.

Social Gatherings

Starting Sunday (May 24), social gatherings up to 100 people may take place following the CDC social distancing guidelines. Gyms and movie theaters are opening at limited capacity and playgrounds, sports fields and sports and community pools may open.  

Restaurants

Restaurant’s dining rooms will continue to operate at 50% capacity in Stage 3. In Stage 4, they can move up to 75% capacity, which is scheduled to begin June 14. 

Retail

Retail, currently operating at 50% capacity, can move up to 75% capacity in Stage 3. 

Manufacturing

If not already operating, manufacturers can open but must meet IOSHA and CDC guidelines, make provisions to maintain social distancing, and consult industry best practices.

What Limitations Will Remain?

• Hoosiers 65 and older and those with known high-risk medical conditions should limit exposure at work and in their communities.
• Continue remote work when possible.
• Face coverings are recommended.
• Nursing homes remain closed to visitors; nursing home guidance will continue to be evaluated. 

For more information on the Back on Track Indiana plan click here.

Whitley County EDC

COLUMBIA CITY, Ind. (May 13, 2020) ­­­– Iotron Industries, a global leader in radiation processing, broke ground on their expansion project during a time when sterilization is a key priority. The expansion will add 34,000 sq. ft. to facilitate another line of sterilization capability.

“Over the last few years, due to increased market demand in the U.S. and Canada, our Indiana facility has grown to full capacity,” said Aaron Starkey, Iotron’s Vice President of U.S. Operations and Head of Business Development. “The current global pandemic has further bolstered the need to increase the supply for reliable, high scale and domestically available irradiation services.”

Construction for the expansion began earlier today with a groundbreaking ceremony led by The Hagerman Group.

“We are honored to once again handle Iotron’s construction needs in the U.S.,” said Hagerman Executive Vice President Brad Smith. “Year over year, most of our projects are with existing clients, which demonstrates the relationships and trust we build and maintain with our clients. We congratulate Iotron on this expansion project, as together we build a better future.”

Iotron Industries currently operates in a 54,000 sq. ft. facility in Park 30 and provides sterilization, bio-reduction and material modification services for the orthopedic, medical device and agricultural industries. The existing site houses Iotron’s IMPELA® brand electron-beam accelerator system, which uses no radioactive materials and is powered by standard commercial electricity.

“Whitley County is fortunate to have this unique company as a part of our diverse economy,” said Dale Buuck, Whitley County EDC president.  “On behalf of our business community, I want to congratulate the Iotron team on their past success and I’m excited to see where the future leads them.”

At the request of the Whitley County Economic Development Corporation (EDC), the Whitley County Redevelopment Commission (RDC) approved financing for Iotron’s expansion project through a bond agreement.

“The bond was a great way to incentivize Iotron’s expansion to save the company interest costs and use funds already generated by the Tax Increment Finance (TIF) district to continually improve economic development in the county,” said Jim Argerbright, Whitley County RDC president. “The use of the bond shows our flexibility as a county and alleviates the use of a tax abatement for taxpayers.”

Iotron Industries expanded its operations to the United States and Whitley County in 2011 and chose to expand in Columbia City due to the proximity to local orthopedic, medical and agriscience industries, along with being ideally situated for coast-to-coast logistics and distribution.

“With this expansion, we will create 30 to 40 new jobs during the next three years,” added Jeff Blakely, Iotron’s Corporate Vice President of Organizational Development.  “This is just the next chapter in Iotron’s 30-year history,” Blakely continued.  “Our plan moving forward is to continuously innovate, add to our already superb skill sets, position our employees for success and scale our business to meet the needs of our customers. We are extremely proud to have reached this milestone, thanks to the continued dedication of our people, our strong customer partnerships and the unwavering support from Whitley County and the State of Indiana.”

The Iotron expansion is scheduled to be completed this year.

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Medical Device and Diagnostics Industry (MD+DI) – Amanda Pedersen

FDA has given the green light to Rutgers Clinical Genomics Laboratory for its COVID-19 laboratory developed test (LDT), which now offers the option of using home-collected saliva samples. The test remains prescription only.

To be clear, this isn’t the first test the agency has authorized with a home-collection option, but it is the first saliva-based COVID-19 test with a home-collection option. Rutgers’ test previously had been added to FDA’s high-complexity molecular-based LDT “umbrella” emergency use authorization to permit testing of samples self-collected by patients at home using the Spectrum Solutions SDNA-1000 saliva collection device.

Last month FDA authorized the first diagnostic test with a home-collection option, but that test uses a sample collected from the patient’s nose with a nasal swab and saline. That authorization is for LabCorp’s COVID-19 RT-PCR test using samples patients collect themselves with LabCorp’s Pixel home collection kit.

“Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19. This provides an additional option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor’s office, hospital or testing site,” said FDA Commissioner Stephen Hahn, MD. “We will continue to work around the clock to support the development of accurate and reliable tests, as we have done throughout this pandemic. The FDA has authorized more than 80 COVID-19 tests and adding more options for at-home sample collection is an important advancement in diagnostic testing during this public health emergency.”

For more information about FDA-authorized COVID-19 tests and policies, check out these frequently-asked regulatory questions on the subject.

To safely open Indiana’s economy and remain vigilant about protecting our health and well-being, Governor Holcomb has laid out a road map to get Indiana back on track.

5 Stages to get Indiana Manufacturing Back on Track

Stage 1: Essential Employees Only (March 24 – May 3)

Stage 2: Open with Restrictions (May 4 – 23)

• Manufacturers that have not been in operation may open following OSHA and CDC guidelines.
• Screen employees daily; utilize face coverings according to best practices guidelines
• Make provisions to maintain social distancing
• Consult industry best practices
• Provide employees, customers w/ your COVID-19 policies

Stage 3: Fully Open with Social Distancing (May 24 – June 13)

• Open, must meet OSHA and CDC guidelines

Stage 4: Fully Open with Social Distancing (June 14 – July 3)

• Open, must meet OSHA and CDC guidelines
• Screen employees daily; utilize face coverings according to best practices guidelines
• Make provisions to maintain social distancing
• Consult industry best practices
• Provide safety plans

Stage 5: Fully Open with Social Distancing (July 4 – Beyond)

• Open, must meet OSHA and CDC guidelines
• Screen employees daily
• Provisions for employees to maintain social distancing
• Consult industry best practices
• Provide safety plans

More information about the Back On Track Indiana plan can be found at www.backontrack.in.gov .

Reuters

(Reuters) – Roche (ROG.S) has won emergency approval from the U.S. Food and Drug Administration (FDA) for an antibody test to determine whether people have ever been infected with the coronavirus, the Swiss drugmaker said on Sunday.

Thomas Schinecker, Roche’s head of diagnostics, said the company aims to more than double production of tests from about 50 million a month to significantly more than 100 million a month by the end of the year.

Governments, businesses and individuals are seeking such blood tests to learn who may have had the disease, who may have some immunity and to potentially craft strategies to help end national lockdowns.

Basel-based Roche, which also makes molecular tests to identify active COVID-19 infections, said its antibody test has a specificity rate exceeding 99.8% and sensitivity of 100%, meaning tests would show very few false positives and no false negatives.

A false-positive result could lead to the mistaken conclusion that someone has immunity. Roche said its test relies on intravenous blood draws, with higher accuracy than finger-prick tests.

“If you take blood from a finger prick, you will never be able to achieve the same level of specificity that you will achieve … when you take blood from the vein,” Schinecker said.

“You have to have very, very high specificity. Even 0.1% or 0.2% makes a difference.”

RIVALS’ TESTS

Similar antibody tests have also been developed by companies including U.S.-based Abbott Laboratories (ABT.N), Becton Dickinson (BDX.N) and Italy’s DiaSorin (DIAS.MI).

Abbott has said the specificity and sensitivity of its test are 99.5% and 100% respectively. Diasorin has said its Liason XL test has 97.4% sensitivity and 98.5% specificity.

As demand escalates for antibody tests, an array of distributors with no background or established testing competency have also joined the experienced companies in an all-but-unregulated marketplace in the United States, according to a Reuters investigation.

Roche did not disclose a price for its test but said that it would be identical worldwide.

Schinecker foresees a high need for testing healthcare workers and their families for exposure, and those who showed signs and symptoms, to see if they have antibodies.

While antibodies typically confer some immunity, Schinecker acknowledged that much remains to be learned about the novel coronavirus before drawing definitive conclusions.

“Since this virus is not well known, one can hypothesise, but the proof will take longer,” he said. “Testing these people … is key to seeing whether or not people really have developed immunity.”

Read Reuters’ story here:
https://www.reuters.com/article/us-health-coronavirus-testing-roche-hldg/roche-wins-u-s-nod-for-covid-19-antibody-test-aims-to-boost-output-idUSKBN22F02Q