Category: Health

The pandemic wrought remarkable changes in diagnostics, some of which may improve healthcare for future generations. It also precipitated a dramatic expansion for Philadelphia-based mini PCR instrument and assay developer Biomeme.

The company is now using revenues from CAP and CLIA accredited testing labs it owns to create a sample-to-answer instrument and further differentiate itself through a focus on host-response testing.

Biomeme was founded in 2013 to commercialize a mini PCR system called Franklin. The company debuted a wholly owned subsidiary of testing labs, called One Health Laboratories, in February of 2019, in part to capitalize on the attributes of the Franklin system, according to Jesse vanWestrienen, a Biomeme cofounder and executive VP of products.

“We felt that a lot of the types of products that Biomeme was creating would be really useful in [lab-developed test] environments and would add some capabilities that other CLIA and CAP labs don’t necessarily have,” vanWestrienen said, like mobility and ease of use.

The firm validated a lab-developed respiratory panel for influenza A, influenza B, and respiratory syncytial virus prior to the pandemic.

Then the pandemic hit and there was a dire need for SARS-CoV-2 testing. In May of 2020, Biomeme obtained Emergency Use Authorization for a lab-developed SARS-CoV-2 assay to be run at One Health Labs, and three months later, it received a second EUA for a modified test using the firm’s two-minute manual nucleic acid extraction kit, called the M1 Sample Prep Cartridge, and running on the Franklin or on standard thermal cyclers.

“Then, it was a matter of scaling because obviously, the demand was insane,” vanWestrienen said.

Over the course of the pandemic, One Health Labs has overseen more than 100 temporary testing sites using the Franklin mobile PCR system.

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Biomeme, the leading provider of portable PCR testing solutions, has signed a definitive agreement to acquire Predigen, a privately held diagnostic company and emerging leader in precision medicine focused on host response diagnostics.

Predigen’s acquisition will expand Biomeme’s capabilities across infectious disease and clinical microbiology, business management, and commercialization.

redigen’s portfolio includes flagship host gene expression biomarkers for the pre-symptomatic detection of viral infections as well as biomarkers that accurately discriminate viral from bacterial infections to enable appropriate patient management and antibiotic stewardship. Predigen also has signatures for sepsis diagnosis, sepsis risk stratification, and a pipeline of biomarkers for non-infectious diseases. With nine different patents at various stages of execution, this scientific team has received over $50 million in grant funding from the Department of Defense (DoD), National Institutes of Health (NIH), Department of Veterans Affairs (VA), and Department of Homeland Security (DHS).

According to Brian Best, Predigen’s CEO, “Prior to the pandemic, the over-utilization of antibiotics and increasing antimicrobial resistance were dominant concerns among the infectious disease community. That need still exists and it is a significant market opportunity that requires accurate, near-patient and rapid-result performance capabilities. This merger will enable an end-to-end solution to meet this challenge.”

Read the full article here.