Staffing grows in preparation for seven FDA submissions and production later this year
CLEVELAND – IdentifySensors® Biologics, a leading developer of digital diagnostic technologies, has named four new industry specialists in regulatory, quality and supply chain to oversee good manufacturing and FDA submissions for the company’s Check4® digital diagnostics platform product pipeline.
“I am very excited about this new quality and regulatory team,” said IdentifySensors CEO Greg Hummer, M.D. “This is one of the most proficient and accomplished groups in the diagnostics industry, as we move this breakthrough technology through the regulatory process and on to large-scale manufacturing.
The new team will report to Ghazi Kashmolah, IdentifySensor’s executive vice president of regulatory affairs and chief quality officer. New team members include:
- Kevin Amacker. With extensive experience managing in vitro diagnostic devices, design control processes, ISO 13485 compliance and risk management, Amacker will serve as director of Quality.
- Felicia Hosey. Having overseen, written and formulated more than 75 successful medical device and in vitro diagnostic device submissions globally, Hosey will serve as director or Regulatory.
- Andrea Wallin. With more than 20 years of experience managing substantial sourcing and supply-chain groups, Wallin has overseen annual budgets of more than $200 million. Wallin will serve as director of Supply Chain.
- Herma Hoda. As a mechanical and software engineer in the medical device space, Hoda has extensive expertise with deploying, testing, design controls, process improvement, quality management and mechanical and materials engineering for in vitro diagnostic devices. Hoda will serve as manager, Design Quality Engineering.
The new team, led by Kashmolah, will oversee quality, manufacturing, regulatory, sourcing and supply chain logistics for the planned Check4® digital diagnostic devices throughout the next 24 months.
The Check4® system platform consists of the Check4® assay kit, including a sample collection device and assay cartridge, test reader, cloud reporting system and mobile application. It is intended that as many as three pathogens can be detected and differentiated simultaneously from a saliva sample within each cartridge.
The technology works on graphene-based biosensors inside the cartridges that target specific sequences of nucleic acids within five minutes. The digital platform works on a molecular gene level and uses no enzymatic amplification or reagents. Other body fluids are planned for future development.
It is intended that biosensors inside the test cartridges will be functionalized for a wide range of infections and diseases, including respiratory illnesses, such as Coronavirus (COVID-19), Influenza and RSV. Diarrheal pathogens, including Norovirus, Rotavirus and Adenovirus are under development along with sexually transmitted diseases.
The company also is advancing diagnostics for bacterial targets such as Methicillin-Resistant Staphylococcus Aureus (MRSA), Legionella, Tuberculosis and foodborne pathogens such as E Coli and Salmonella. Other high-priority pathogens include Hepatitis C, HIV and Lyme.
This platform and its multiple elements are not yet approved for sale in the United States or other international markets.