NEW YORK (GenomeWeb) — Aeon Clinical Labs has begun offering a panel test developed by Thermo Fischer Scientific to detect 34 different women's health-related pathogens, and the firm is planning to expand its genetic testing menu in the future.
Thermo did a soft launch of its 34-target, research-use-only women's health panel this summer. In terms of uptake since that time, the firm is "very pleased with the interest and response to our RUO, vaginal microbiota offering," a representative said in an email.
The test Aeon has launched is the Thermo panel, an Aeon representative confirmed, but the platform and assays to perform the test were validated by Aeon's labs. The representative noted that the test has not been cleared or approved by the US Food and Drug Administration, but that the FDA has determined that such clearance or approval is currently not necessary for clinical use of this test.
"The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions," a spokesperson noted, also adding that the assay "has been validated pursuant to the CLIA regulations and is used for clinical purposes."
Founded in 2010, Gainesville, Georgia-based Aeon initially offered physician-ordered toxicology testing in its CLIA labs, particularly for prescription and illicit drugs. Its customer base for this testing includes recovery centers, general practitioners, and Ob/Gyn doctors, with a customizable test menu of more than 85 analytes using HPLC-tandem mass spectrometry.
But Aeon also began offering genetic assays the following year, including pharmacogenomics and hereditary cancer testing.
"We see genetics as a key growth engine for the business going forward," William Henry, the firm's chief operation officer, said in an interview.
In January of this year, Aeon merged with Authentidate Holding Corp., a provider of web-based revenue management applications and telehealth products and services, in exchange for shares of a newly created class of Series E Preferred Stock of Authentidate. Aeon became a wholly-owned subsidiary of Authentidate, to be operated as a separate entity. "We have been able to get to the public market via that acquisition," Henry explained.
The firm is now in the process of renaming itself as Aeon Global Health, and that business will focus on the clinical lab side through the Aeon subsidiary as well as telehealth. "We're delivering a series of telehealth solutions to a variety of providers across the US, and looking to dramatically ramp up our telehealth growth strategy," Henry said.
The company has 124 employees, and, for the 12 months ending in December of 2015, it had $34.9 million in revenue, Henry said.
Aeon reaches its physician customers via a direct sales force that covers the entire US. The firm also drives a lot of business using an indirect sales force of independent 1099 sales representatives who work with clinics. Aeon is also currently growing its business through partnerships with pharmacies, specifically in the PGx space, Henry said.
For its women's health panel, patient samples are processed in Aeon's clinical lab from all over the US, and Henry noted that there is little variation in turnaround time for local samples compared to ones from as far away as Washington or Texas, for example. The test has a total turnaround time of five days from receipt of sample to sending a report, which the firm notes is much faster than typical microbiology testing.
Furthermore, since the test is PCR-based, it may also be more accurate than microbiology. Lina Syssoeva, Aeon's business development manager, noted that the test uses OpenArray plates on Thermo Fisher Scientific's QuantStudio 12K Flex Real-Time PCR platform.
The panel runs from a single vaginal swab sample, Syssoeva said, and physicians can choose to run all 34 targets or narrow it down to just STIs, for example, with pricing depending on number of targets and insurance company agreements.
The ability to run all 34 targets — which include sexually transmitted diseases such as chlamydia and gonorrhea, candidiasis, bacterial vaginosis, and other microbial organisms including bacteria, fungi, viruses, and protozoa — is particularly valuable because clinical symptoms often vary from person to person, overlap between different kinds of infections, and patients can have co-infections.
"It's better to be able to run a test for all of the organisms at once, because without that you could have a much higher rate of missed diagnosis due to variation in clinical symptoms," Syssoeva said. For example, a patient's symptoms might be consistent with a bacterial vaginosis infection but could actually result from a candida infection or an STI.
There are commercial panels for women's health that cover a smaller number of targets — Becton Dickinson recently launched a triplex STI test and a bacterial vaginal panel, for example — but Syssoeva said she believes the test Aeon offers is the largest panel currently available. "Clients seem to be very excited about this test ... it's an easier way for them to see what microorganism is causing the infection so they can prescribe and treat more specifically," she said.
Next steps for Aeon will involve offering additional testing. "We see this whole genetic testing area as still in its infancy, and we're working on bring a series of really exciting new genetic tests to the market over the course of 2017," Henry said, noting that the next likely offering will be cystic fibrosis testing.