Novel Quantitative Sampling for Biofluids

Novel Quantitative Sampling for Biofluids

An Interview with Fasha Mahjoor, founder of Neoteryx LLC, regarding novel quantitative sampling for biofluids:

FM:  I am the Founder and CEO of Neoteryx LLC in Torrance, California. My educational training is in architecture, but I always had a passion for business and science. In 1982 I became an entrepreneur and founded Phenomenex, a company specializing in separation sciences/chromatography. Phenomenex became the leader in the chromatography consumable market and was bought by Danaher in 2016 allowing me to focus my energies on Neoteryx.

RLS: What is Neoteryx?

FM: From Our mission vision or statement: Founded in 2014, Neoteryx is a medical device company shaping the future of healthcare. Our mission, as the blood microsampling innovator, is focused on providing simple, convenient, and economical alternatives to traditional blood draws to fuel the virtual revolution in healthcare, medicine, and research.

RLS:  What was your Initial product?

FM:  VAMS® technology, currently available via a product called the Mitra® Microsampling device, is the missing link in the age of modern healthcare.  Collecting blood with the Mitra device is a new and different sort of sampling event. ​

It's the first device designed to collect quantitative and volumetrically accurate samples of dried blood (or other bio fluids), typically from a finger-stick. It's available in patient-centered and lab-centered formats, and it's easily amenable to laboratory automation. Because of its accurate and precise nature, results generated by labs from VAMS technology typically correlate with traditional clinical reference ranges. ​

Mitra microsamples are having a big impact. By taking blood collection out of the clinic, it is changing the world of pharmaceuticals, clinical trials, clinical testing and research, preclinical research, health and wellness, and beyond.

RLS What is your Intellectual property? 

FM:   VAMS is a patented technology. There are multiple patents on the VAMS technology that address a multitude of applications. In terms of our regulatory position,

Mitra is an FDA Class 1 Medical Device in the USA, a CE-IVD self-certified Device in the UK and European Union​ and registered with Health Canada.

RLS:  How many employees?

With under 100 employees, Neoteryx is small but mighty, and growing every day to meet the increasing demand for our innovative microsampling devices for multiple research studies during the COVID-19 crisis, and many other applications.

RLS:  What about manufacturing:

Neoteryx manufactures its microsampling devices in Southern California. Recently, we have scaled our manufacturing facilities to accommodate the intense demand for our remote specimen collection technology.

RLS:  What is your distribution model:?

FM: Neoteryx sells direct to its customer base of research, pharmaceutical, and healthcare organizations across the globe, with the exception of South Africa where we distribute our Mitra devices through our partner, Separations.

RLS: How does it work?

FM: The Mitra microsampler blood collection kits use a simple finger-stick method that can be used by anyone, anywhere. No phlebotomist or healthcare professional is needed, though these professionals also appreciate the Mitra’s precision and simplicity. Mitra Blood Collection Kits include the Mitra microsampler, lancets and other supplies for collection and shipping.

The individual uses the lancet to prick their fingertip, touches the Mitra device to the blood drop, allows the blood to absorb on the Mitra tip ( which happens in just seconds), secures the sample in its case, puts the case into a sealed pouch, then inside an outer envelope. They send it back to the lab or their provider by dropping it in the nearest mailbox. The packaging is sealed up and safe for handling.

RLS:  How well does it work?

FM:  The Mitra microsampling with VAMS technology works very well, and Neoteryx has provided its devices for hundreds of validated studies, with more than 100 publications in peer-reviewed journals testifying to its efficacy. Our Mitra VAMS technology represents an improvement over traditional DBS cards, or dried blood spot cards, which don’t always deliver the right volume of blood or a quality sample for proper study and analysis. The absorptive tips on the Mitra with VAMS consistently deliver the precise volume of blood for validated studies. Scientists value our Mitra® 96-Autorack™, which enables any lab to process microsamples in a high throughput manner, whether for sample accessioning or processing.

RLS: Any other attractive applications?

FM:  The VAMS technology is a modern alternative to traditional, in-clinic venipuncture blood draws. The applications, of course, are what matter here. We have witnessed our technology improving lives for malnourished children in Africa who don’t have access to testing laboratories. It’s helping organ transplant patients live fuller lives than they imagined possible, whether they are mountaineering or eliminating lengthy drives to and from transplant clinics. Our technology is enabling consumers to take a more personalized approach in managing their own health by enabling at-home blood sampling for online laboratory tests.

RLS: How did you get involved?

FM:  VAMS technology was incubated at Phenomenex, my former company, between 2010 and 2014. During this time, the research and development of the technology occurred with the cooperation of several leading, global pharmaceutical companies. I invested very heavily in this incubator, to accelerate the release of a technology that would modernize blood collection and thus laboratory testing to make it more convenient, comfortable, and accessible. When we got market validation, the decision was made to spin out Neoteryx into its own entity, though it was a risk. However, when I notice an innovative and game-changing opportunity and, more importantly, a product that improves lives and convenience on all fronts as well, I can hardly afford the risk of not doing it! Of course, it’s been extremely hard work and I continue dedicating my entire time to it as I did at Phenomenex.

RLS: Can you give more color on the sampling for Covid 19?

FM:  Neoteryx is honored to be part of the effort to understand and fight COVID-19 by providing our Mitra blood collection devices to top research and healthcare organizations like the National Institutes of Health, Wake Forest Baptist Health, and others. Researchers at these organizations are conducting serology surveys, where they analyze blood samples from healthy volunteers who have not had a COVID-19 infection or have perhaps had an exposure but didn’t develop symptoms.

The NIH, Wake Forest and others are deploying our Mitra Blood Collection Kits out to volunteers, who can collect their own blood samples remotely at home and send them back to the research lab for analysis. Thanks to our Mitra devices, the volunteers can stay safe at their remote location, and the researchers can use their blood samples to determine who has developed antibodies against the novel coronavirus.

RLS:  What about different strains?

Researchers at academic institutions and others are using our Mitra devices to remotely collect blood samples for drug studies as potential therapies for COVID-19. Some researchers are using blood sampling to investigate hydroxychloroquine, an antimalarial medication that may have potential in diminishing a person’s immune response to the coronavirus. Others are using our devices in seroprevalence studies to gauge the immunity of a population and help inform decisions about when it's safe or not to return back to “normal” life.  Still, other organizations are looking to use our remote blood sampling devices to tests their employees for COVID-19 exposure and immunity to clear them to return to work.  

RLS: There are ~ 7 billion people on the planet.  How long until you could produce the first million and billion of blood microsamplers?

FM: While in an ideal and perfect world it would be great to test every single human being, but that is neither practical nor would it really be necessary. Mitra provides a world of information to the researchers at healthcare institutions and they would decide on the number of people that need to be tested in the US or other countries.

Neoteryx will continue being part of the solution, and we will do whatever it takes to meet the demand for our Mitra microsamplers so that our partners at leading research and healthcare organizations can continue using our microsamplers to develop more effective tests and treatments. We are producing as many Mitra microsamplers as needed and continue increasing production on our fight against COVID-19.

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