NEW YORK – Building on its established reagent and assay development business, BioGX has recently begun offering a complete molecular diagnostics platform that it foresees helping it penetrate the point-of-care testing market.
Called the Pixl, it is a four-channel, 16-well portable qPCR platform that boasts turnaround times of less than an hour. The system is also potentially compatible with the BioGX suite of lyophilized molecular diagnostics assays.
BioGX debuted the Pixl at the American Association for Clinical Chemistry annual meeting last month. The firm also obtained the CE mark for the Pixl system in July along with a SARS-CoV-2 test that uses the firm's direct-from-sample chemistries, called Xfree.
Pixl is currently available in countries that accept the CE mark as well as in the US for research use only, and BioGX now plans to pursue Emergency Use Authorization from the US Food and Drug Administration for the system, CEO Shazi Iqbal said in an interview. The firm's ultimate goal for Pixl is to obtain CLIA waiver.
Birmingham, Alabama-based BioGX was initially founded in 2007 by Michael Vickery, the firm's current CSO and executive VP, to sell and market Cepheid's water quality and food safety tests and SmartCycler instrument. BioGX was re-founded in 2010 as a molecular diagnostics firm when Iqbal joined the team as a cofounder.
The firm offers custom manufactured lyophilized qPCR assays that can be validated and used by clinical labs as laboratory-developed tests. Iqbal claimed the company has the largest portfolio of lyophilized tests in the world.
With approximately 100 employees, the privately owned firm also has "easy access to talent" from the University of Alabama, Birmingham medical school and biotechnology departments, Iqbal said. It recently expanded its footprint in Birmingham to include additional office, lab, and manufacturing space.
BioGX's wholly owned European subsidiary in Amsterdam opened in 2017 and markets nearly 30 CE-IVD products and supports approximately 30 European distributors serving more than 80 countries, Iqbal said.
Spurred by the pandemic, the company also opened an additional US commercial office in Dallas to support expansion of its sales and marketing team.
BioGX's core strength is in developing chemistries that enable rapid molecular diagnostics assays, Iqbal said. Indeed, Vickery had worked at the FDA as a lead for molecular methods development prior to a role in sales and marketing at Cepheid, where he and some colleagues patented a novel internal amplification control system.
But as the firm entered the diagnostics space with its chemistries, "we saw that other companies were going to have sample-to-answer platforms," Iqbal said, offering simple "black box" solutions to customers.
However, "the challenge for companies is to develop a menu," Iqbal said. "We focused on developing the core chemistry and technology, and made it robust to make sure it is compatible with multiple platforms and specimen types," he said.
This, in turn, has allowed BioGX to collaborate with companies like Cepheid and Becton Dickinson to bring more assays onto their systems.
BioGX received the CE mark for an influenza and respiratory syncytial virus test on the BD Max in 2016, followed in 2017 by CE marking for four other infectious disease assays — Mycoplasma and Ureaplasma species, Pneumocystis jirovecii, Mycobacterium tuberculosis, and a Bordetella speciation and toxin test.
In 2018, BioGX obtained the CE mark for six assays to detect meningitis and antibacterial resistance. Upon the CE marking of its expanded flu/RSV test in 2019, the firm noted that it had 23 tests CE marked on the BD Max system in total.
BioGX has also partnered with Bosch Healthcare Solutions to develop tests for its Vivalytic point-of-care system, launching their first product — a multiplex mycoplasma test — in April at the European Congress of Clinical Microbiology and Infectious Diseases annual meeting.
And last month, the firm signed an agreement with Cepheid to develop a monkeypox assay for the GeneXpert.
BioGX also has relationships with different US government agencies, Iqbal said. For example, since 2013 it has supplied the assay for which the FDA issued guidance for use in detecting heparin contamination.
BioGX has worked with the US Centers for Disease Control and Prevention to produce the CDC multiplex monkeypox and orthopox assay, and partnered with Cepheid to manufacture the assay. Vickery is also an author on a 2017 evaluation of the test that was carried out in the Democratic Republic of Congo.
The test "has very robust performance, both in terms of sensitivity and specificity," Iqbal noted.
Working with the DoD, the firm produced a lyophilized malaria assay that is used in sub-Saharan military outposts, Iqbal said.
In addition, the firm has collaborated to support NASA's testing on the Cepheid SmartCycler instruments that are used aboard the International Space Station, Iqbal said.
"We developed chemistry for them to allow running assays in space that are almost bubble-free," he said, adding that the firm's kits are frequently sent up in the SpaceX capsules that resupply ISS.
Independently, BioGX obtained CE-IVD marking for a combination SARS-CoV-2, influenza A and B, and respiratory syncytial virus in September 2020.
When customers started to be impacted by the global shortage of extraction kits, BioGX took on the challenge to develop direct-from-sample chemistries, Iqbal said.
The firm obtained EUA on its direct-from-sample Xfree COVID-19 Direct RT-PCR assay in July of last year, and last month obtained the CE mark on a three-gene "future proof" Xfree COVID assay for Pixl, Iqbal said.
And, "while everyone's COVID testing was going down, we continued to grow our business," Iqbal said, noting that the firm's assays enable customers to consolidate COVID testing and not worry about having cartridges or reagents on hand. Lyophilization also simplifies storage and obviates the need to thaw master mix, thus reducing waste.
Gregory Meyers, chief operating officer at Next Molecular Analytics near Richmond, Virginia, said in an email that his lab switched to the Xfree COVID-19 Direct RT-PCR kit from a modified version of the CDC COVID-19 assay after the agency decided to no longer support their kit under EUA use.
"The BioGX kit is easy to use and provides robust and accurate results allowing us to keep our high-throughput COVID pipeline running efficiently," Meyers said.
Pixl and beyond
The firm has continued to simplify its chemistries, going from lyophilized tests that required the addition of water to tests that only require the addition of sample.
"Everything is developed and manufactured at BioGX, so we aren't dependent on any outside company," Iqbal said. "As a result of that, we are able to quickly innovate."
The success of the Xfree assays inspired a desire to offer a complete solution, Iqbal said, and the firm began working with an undisclosed US contract manufacturer to quickly develop Pixl.
Although the point-of-care molecular diagnostics space seems to have gotten more crowded during COVID, the 16-well capabilities of Pixl is a differentiating factor, Iqbal said, since most competitors use single cartridge or single test formats.
With the Pixl, customers can run tests on 16 patient samples, or up to 16 different tests on a single sample, with as many as four targets per test, if needed.
The Pixl can report out Ct values, or it can be set up to call positive or negative test results. The firm's software enables sample accessioning and can create reports that can be customized to adapt to a customer's laboratory information system, Iqbal said.
Ultimately, the firm plans to submit the three-gene COVID test along with the Pixl system to the FDA for 510(k) and CLIA waiver.
BioGX will target hospital and reference labs as well as physician offices with Pixl, but not the at-home market in its initial forays. "That market is not ready," Iqbal said, in part because consumers are not currently interested in purchasing and storing an inventory of perishable tests in their homes.
The firm's suite of lyophilized tests may also engender a particular advantage in the POC space, as a large menu could differentiate Pixl from the competition.
BioGX is now developing a pipeline of Xfree-Pixl assays, and is also developing a smaller POC instrument that will be able to process four Xfree tests at a time.
And, while the current 16-well Pixl can detect four targets per sample, a future version of the 16-well platform will be able to detect five to six targets, Iqbal said.
BioGX intends to further differentiate itself from the competition by its price point for tests and instruments, in part due to its simplified chemistries, Iqbal said.
The list price of the 16-well instrument is approximately $18,000, with reduced pricing for customers who contract to buy higher volumes of tests. The cost for the Xfree POC test for the Pixl system in Europe is in the range of $10 to $20 depending on the volumes, Iqbal said.
The firm hasn't priced the four-sample device, but Iqbal said BioGX may deploy the business model of offering the instrument for free along with a subscription for assays.
Prior to last year, the firm only sold through partners and distributors, including Thermo Fisher Scientific and Medline in the US, but now the company aims to have its own sales and marketing team, Iqbal said. The firm has been selling product since it was founded and has never taken any outside funding, Iqbal said. It plans to continue generating its own cash to invest back into the company, he said.
Overall, "this is an exciting time for us," Iqbal said.