A subsidiary of OraSure Technologies announced it has received emergency use authorization from the FDA  for its saliva collection and stabilization device in COVID-19 testing.

Lehigh Valley’s vibrant life sciences sector has been stepping up to the challenge created by the continuing COVID-19 crisis, with companies like OraSure Technologies, Skillion, Inc., and Saladax Biomedical taking steps in the past month to help fight the coronavirus and other deadly diseases.

Life science research and technology is one of the target sectors of the Lehigh Valley based on the site-specific characteristics of the regional economy. This includes Lehigh Valley’s central northeast location, well-developed transportation infrastructure, strong workforce, and high-quality educational institutions.                                                                           

A target sector

The Lehigh Valley Economic Development Corporation (LVEDC) has been working to recruit and retain companies from this sector, to market the region to attract life science and medical equipment companies, and highlighting the successes of existing businesses here like B. Braun, Olympus, Tyber Medical, U.S. Specialty Formulations, and more.

“Lehigh Valley has everything life science companies want in a location, from proximity to large consumer markets, to access to skilled labor and outstanding colleges and universities,” said LVEDC President & CEO Don Cunningham. “We’re confident that there’s a bright future for the innovative life sciences industry in Lehigh Valley.”

The life sciences sector employs nearly 6,000 people in the Lehigh Valley, with average annual wages of $97,750, according to JobsEQ. That’s nearly twice the average wage across all occupations in the region.

Out of 41 active manufacturing projects or prospects currently being tracked by LVEDC, nine are pharmaceutical or medical device manufacturers.

OraSure Technologies

DNA Genotek, a subsidiary of the Bethlehem-based OraSure Technologies, announced last week it has received emergency use authorization from the U.S. Food and Drug Administration (FDA) for its saliva collection and stabilization device in COVID-19 testing.

The device, called DNA Genotek’s OMNIgene·OR, marks the first such FDA authorization that allows for the unsupervised use of the device at-home or in a healthcare setting when used as part of an approved or validated at-home test kit, meaning patients can safely collect their own sample, without the presence of a healthcare professional.

“Since the beginning of the pandemic, DNA Genotek has been committed to addressing this global health emergency, and we are pleased to be able to provide a robust solution for easy, safe sample collection that supports detection of this highly contagious virus,” said Kathleen Weber, Executive Vice President, Business Unit Leader, Molecular Solutions at DNA Genotek.

OraSure had already announced this summer plans to expand its manufacturing operations in Bethlehem to help meet demands for its new in-home coronavirus self-test. The $7.5 million expansion will mean the creation and retention of more than 400 jobs.

Skillion

Meanwhile, the technology company Skillion is creating a device that can detect if you’re wearing a mask, according to Ben Franklin Technology Partners of Northeastern Pennsylvania. BFTP/NEP runs the Bethlehem incubator Ben Franklin TechVentures, in which Skillion is based.

Skillion is producing “connected dashboards” that use artificial intelligence and machine learning to do various tasks. This includes sensing whether a person is wearing a mask, which local businesses could use to help prevent the spread of the coronavirus.

“Basically, it’s something you can just position onto a stand it runs all day,” Skillion CEO Pete Cooper told WFMZ. “It’s a completely mobile device. And then when someone approaches that, it automatically checks whether they are wearing a mask or not.”

Saladax Biomedical

Saladax Biomedical, a precision medicine company also based in TechVentures, has hired eight new employees in research & development, operations, regulatory affairs, and sales to ramp up production of its test for Clozapine, a key medication in the treatment of schizophrenia.

The test earned FDA market authorization in April. Saladax’s MyCare Psychiatry Clozapine Assay Kit is a rapid blood test that measures Clozapine levels in psychiatric patients, and is the only such commercial test available in the United States.

“The MyCare Psychiatry Line of tests reflects our commitment to bringing crucial clinical tools to mental health practitioners to help them make informed decisions and enhance patient care,” Saladax CEO Salvatore Salamone said. “MyCare tests will support practitioners who are contending with schizophrenic conditions in their patients.”