NEW YORK – 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.
Joe Tumolo, Biomeme's VP of sales and strategic partnerships, noted that the growth spurred by these testing labs was "substantial." The firm expanded from roughly 35 employees to approximately 400, and from a single location to eight, spread across the US.
More recently, Biomeme also moved into new, 50,000-square-foot headquarters in Philadelphia that houses lab, administrative, and manufacturing space.
The firm also established and scaled up its own manufacturing during the pandemic, according to Max Perelman, Biomeme's cofounder, president, and CEO, producing millions of lyophilized SARS-CoV-2 kits. At the new Philly HQ, the firm now manufactures its COVID tests as well as the Franklin qPCR thermal cyclers.
In addition, "Biomeme has made a significant investment in the manufacturing capability of the M1 Sample Prep," Perelman said, that will expand production capacity and lower costs in order to "make this an economical alternative to other manual extraction systems on the market today."
The firm also developed and manufactures its lyophilized PCR assays in different formats, enabling the One Health Lab network to also run testing on high-throughput instrumentation.
These different form factors include vials of lyophilized assays that can be resuspended for high-throughput testing, lyophilized assays in plates, and lyophilized assays in three-well strips for use on the Franklin system. The real-time PCR tests are also frequently multiplex, and the firm is developing proprietary isothermal chemistries, as well. Biomeme has also developed field-friendly sample prep cartridges.
The Franklin can run nine samples in about 90 minutes, with multiplexing of up to three targets. A single sample can also be split, effectively enabling portable panel testing of up to 27 targets.
The system also syncs GPS-tagged data to the Biomeme cloud, enabling remote backup, real-time data analysis, and quality control, as well as integration with third-party lab information management systems and epidemiological databases.
Biomeme recently developed and validated a SARS-CoV-2 variant detection assay with MRIGlobal and US military collaborators. The high-throughput versions of the test work on standard 384- and 96-well systems, while the low-throughput version utilizes Biomeme's M1 Sample Prep Kits, SARS-CoV-2 three-test "Go-Strips," and the battery-powered Franklin thermocycler.
Biomeme received support from FIND in December for the development of a sample-to-answer automated real-time qPCR platform as well as a respiratory panel, called the XCEL Respiratory Test.
As opposed to the legacy manual Franklin system, the new version, called Franklin ISP, will integrate sample prep, including automated lysis, nucleic acid extraction, and purification.
The intention is to deploy the system in low- and middle-income countries, but the manual Franklin can also be useful in those settings, vanWestrienen said.
The ISP is somewhat similar to the Cepheid GeneXpert cartridge, he said, but the system runs nine reactions at a time. "We can have that one consumable run up to 27 targets across the nine reaction wells," he added.
The Franklin ISP system has already been deployed by some of the firm's collaborators in the US government, Perelman said, and Biomeme is now gearing up to begin clinical studies of the XCEL test on the ISP for the coming flu season.
The firm intends to submit the test to the US Food and Drug Administration along with the Franklin ISP for 510(k) clearance early next year. In addition, a version of the instrument now in development is capable of detecting up to 45 targets.
Host response testing
Perelman said the two companies had collaborated for years, and Predigen's innovative content was a great fit with Biomeme's platform.
Predigen Cofounder Chris Woods is now Biomeme's chief medical officer. His prior research has included extensive collaborations with the US military to find signatures of early systemic gene changes that occur when a person is infected with a virus or bacterial species. A test was recently described using BioFire instrumentation, but Perelman noted that the testing will use Biomeme's systems going forward.
Biomeme sees host-response testing as the future of diagnostics, Perelman said, and the high multiplexing of the Franklin system will enable the firm to run these multi-target tests close to patients or in mobile labs.
The first test Biomeme is developing will differentiate bacteria and viruses in acute respiratory infections, Perelman said.
"We've already transitioned the signature onto our manual Franklin platform, and we'll be doing a limited rollout of that test as a service through One Health Laboratories in the next couple of months," he said.
The firm is lining up different organizations that want to participate in the limited rollout and plans to subsequently run its clinical studies for 510(k) submission, with the intent of launching an FDA-cleared quantitative respiratory bacteria and virus differentiation test in 2024.
Biomeme is also collaborating with National Institute of Allergy and Infectious Diseases' Antibacterial Resistance Leadership Group (ARLG) to perform a clinical utility study of that test, Perelman said.
While other companies — like ImmunExpress, Inflammatix, Cytovale, and Presymptom Health — have commercialized molecular host-response tests, many are generally focused on early detection of sepsis as an initial application.
Although Perelman declined to say precisely how much the host-response assay and ISP instruments will cost, as a go-to test meant to be run on anyone who presents with an acute respiratory infection, it will be simple and affordable, he said.
Further plans for the Franklin ISP over the next few years include a series of infectious disease and host response diagnostic tests, as well as research-use only panels for chemical, biological, radiological, and nuclear threat detection, food safety and water quality monitoring, and more.
Funding for expansion
"The pandemic has been a catalyst for the organization," Perelman said, allowing it to ramp up infrastructure and diagnostics capabilities.
In addition, "The revenue from the products and services has enabled us to essentially skip a funding round," he said.
Indeed, Biomeme has only raised $12 million in venture capital since its founding, Perelman said. This has been intentional in order to allow the firm to better focus on its long-term mission.
Marketing VP Tumolo sees this financial stewardship as an extension of Biomeme's overall goals, which encompass antibiotic stewardship, environmental conservation through lyophilization, and lab resource conservation through built-in quality controls.
The firm also anticipates utility of its system for pandemic preparedness using a "One Health" pathogen monitoring approach, enabling global health stewardship.
With COVID viral reservoirs becoming established in wildlife, "we are not going to eradicate SARS-CoV-2," Perelman said, adding that we may see the same thing with monkeypox should it reach US rodent species.
To battle endemic zoonotic viruses, lyophilized SARS-CoV-2 tests engender standardization. They can be deployed across reference, satellite, and point-of-care labs for patient testing, while the same assay can also be run for wastewater, air quality, and wildlife surveillance, Perelman said. In essence, using Biomeme's tests, field researchers can deploy the same validated assays as are run in central labs and quickly share the data.
Finally, the firm has purposely made its Franklin system open for other developers to create their own research-use assays, which can also enable pandemic preparedness. Perelman said the firm will continue to maintain this collaborative stance for future projects, as well.