Neoteryx–A Less Ambitious Version of Theranos?

A California startup has launched a platform that can gather blood in tiny tubes for assays with all but no inconvenience for patients.

And it is not Theranos.

Unlike that troubled Silicon Valley laboratory, Neoteryx is not clashing with federal regulators over the efficacy of its platform, known as Mitra. The U.S. Food and Drug Administration has classified the platform as a class one medical device.

At the same time, the Torrance, Calif.-based Neoteryx has far less ambitious plans to remake the world of laboratory testing. Although the firm has been steadily hiring, it currently has only 20 employees.

.“It is a way to collect and transport blood. We don’t do any assays, and we don’t have any claims of any testing and results,” said Cathy Cordova, Neoteryx’s senior marketing manager.

The company, which was founded in 2014, uses a pen-like device with a spongy tip that absorbs exactly 10 microliters of blood (blood is drawn through a commonly deployed lanced fingerstick).

The sample can be dried within two hours by air or accompanied by a dessicant and can be shipped without a courier and can be processed using common solvents.

The Mitra Microsampling Device is designed specifically for assays that require minimal amounts of blood. According to Cordova, Mitra can be used for ongoing care such as the monitoring of immunosuppressive reactions, as well as some assays that require small amounts of blood. Home testing for pediatric and geriatric patients are another target market, although Neoteryx is also targeting laboratories that performing testing on animals.

Cordova said Neoteryx has some laboratory clients, but declined to name them. She added that the platform is currently being tested by major health care providers such as the Mayo Clinic, Cedars-Sinai Medical Center, and Seattle Children’s Hospital. It is also being tested by Exagen Diagnostics, a San Diego-area laboratory that focuses on autoimmune and neurologic assays.

She would not disclose the cost of drawing a sample, other than it is the equivalent of a dried blood card—$1 to $2—plus a premium.

Peter Francis, the president of Clinical Laboratory Sales Training, a Maryland-based consulting firm, said that competition has been intense regarding the more efficient collection of blood samples.

“Medical device companies and labs have consistently been seeking ways to make specimen collection easier and more convenient. We need to look no further than the marketing story of Theranos Labs,” he said.

The primary difference between Neoteryx and Theranos is that the latter has developed an entire collection and testing platform and is conducting assays and processing on its own. And while Theranos has promised to conduct hundreds of tests using just a few drops of blood, the FDA has approved it for just a single test, an assay for a relatively rare form of herpes.

Francis does believe the Mitra platform has some promising applications, such as making point-of-care blood collection more convenient. However, he has raised concerns regarding home-based collections.

Francis does believe the Mitra platform has some promising applications, such as making point-of-care blood collection more convenient. However, he has raised concerns regarding home-based collections.

“The collection technique describe by Neoteryx requires special attention to several key aspects in order to obtain a good specimen,” he said. “The average patient, especially (the) elderly, may not follow the explicit directions, creating frustration and eventual problems for the lab.” Francis also raised concerns about whether home testing results would consistently wind up in electronic medical records.

Cordova conceded that some training is required to perform the blood draw accurately, although it is primarily isolated to making sure the tip of the collection device is now drawing the blood at a negative angle.

Takeaway: Neoteryx has introduced a laboratory microsampling device that is decidedly less ambitious than what has been marketed by Theranos.