Affordable Point-of-Care Test For Multiple Diseases Being Developed by 1Drop - POCTRN
In response to the COVID-19 pandemic, the RADx program was formed to accelerate the development, validation, and commercialization of innovative point-of-care and home-based tests, as well as improvements to clinical laboratory tests, that can directly detect SARS-CoV-2, the virus that causes COVID-19.
Affordable Point-of-Care Test For Multiple Diseases Being Developed by 1Drop
NEW YORK (360Dx) – 1Drop Diagnostics is developing a portable diagnostic platform that uses a disposable microfluidic biochip to enable inexpensive and rapid testing at the point of care for a broad range of medical conditions.
The platform is undergoing clinical validation and could be ready for regulatory review and clearance within two years, Luc Gervais, the firm's founder and CEO, said in an interview.
With $4.25 million in Series A financing in hand, 1Drop — so named because it uses a single drop of capillary blood for testing — anticipates starting work next year that could lead to CE marking in Europe and US Food and Drug Administration 510(k) clearance in the US in 2020.
According to Gervais, the diagnostic platform should be capable of handling up to 64 clinical biomarkers, including those for cardiovascular diseases, autoimmune indications, glucose metabolism, several organ functions, and infectious diseases.
So far, the multiplexed platform has demonstrated it can inexpensively provide test results within 15 minutes at levels of performance seen today only in laboratory testing, Gervais said. The firm expects to initially launch the microfluidic platform with four cardiovascular biomarkers — NT-proBNP, D-dimer, troponin, and C-reactive protein. The firm anticipates incrementally adding additional biomarkers and getting regulatory clearances to market them.
It plans to sell the platform and its disposable cartridges for at-home use, and to pharmacy centers, doctors' offices, and hospitals, and to target customers through an Internet portal, while its sales team focuses on marketing the firm at conferences to key opinion leaders.
"We want to sell directly to the consumer, and we are exploring partnership strategies with diagnostic and pharma companies, and with companies selling complementary products to our diagnostics such as, for example, stents and pacemakers in cardiovascular applications," Gervais said.
The technology behind the platform is a culmination of the research that Gervais has completed over 15 years of research into biosensors and microfluidics for medical diagnostic applications.
He described the early development of the current point-of-care platform in 2009 in the journal Lab on a Chip. With coworker Emmanuel Delamarche at University Hospital Basel, he described the development of a one-step chip that can detect C-reactive protein at a low concentration in less than three minutes. The work at the time was expected to "spur the adoption of fluorescence immunoassays using capillary-driven microfluidics and PDMS substrates for point-of-care diagnostics."
1Drop — with offices in Boston and in Neuchatel, Switzerland — received a $140,000 grant from the Consortia for Improving Medicine with Innovation & Technology (CIMIT) in 2017 to continue funding the firm's collaboration with Massachusetts General Hospital.
According to Steven Schachter, chief academic officer of CIMIT and a professor of neurology at Mass General, 1Drop's platform would shorten the time patients spend waiting for testing results from days or hours to minutes.
The National Institute of Biomedical Imaging and Bioengineering, one of CIMIT's funders, "saw the platform as being differentiated by the number of different results that could be obtained from a single drop of blood," he said in an interview, adding "We've seen and reviewed other technologies, but they are more limited in their scope of testing."
After Gervais founded 1Drop in 2012, his team initially built prototypes using silicon, but they have since developed an injection molding process that allows inexpensive fabrication of larger volumes of its biochips — one of the main components of the diagnostic platform.
"We knew that we wanted to get to a price that is less than $1 dollar for the cost of manufacturing of a fully loaded cartridge," Gervais said. "We've also developed a reader that is based on photonics and use of electronics for quantifying the concentration of the biomarkers on the chip."
At the center of the diagnostic platform is its disposable microfluidic biochip. The chip uses capillary forces to shuttle sample fluids and reagents between pumps, valves, reaction chambers, and incubation zones. No external pumps, valves, or connecters are needed, which reduces cost and size, and all the biochemical reagents are integrated in picoliter quantities in the biochips, Gervais said.
A biochip, in contact with a single drop of blood, automatically filters and processes the blood sample and completes biochemical reactions so that the photonic reader can detect the concentration of biomarkers in the sample through fluorescence.
1Drop has fabricated more than 50,000 chips in the development and clinical testing of the platform, Gervais said, adding that it has been vetted in three clinical validation studies in hospitals and clinical laboratories, and by pharmaceutical companies. The firm has collaborated to do test validation with Mass General, as well as Harvard University, NASA, and the Swiss Federal Institute of Technology.
It continues to conduct clinical studies to demonstrate the platform's utility for near-patient use, and to develop additional biomarkers and test panels, he said.
The company will use the recently raised funding to expand research and development of its technology and take it through regulatory submissions. In about a year and a half, 1Drop anticipates a second funding round to support the global rollout of the platform and cardiovascular biomarkers.
1Drop is working with three undisclosed pharmaceutical firms to develop companion diagnostic tests for cardiology, autoimmune disease, and glucose metabolism drug candidates. One of the pharma companies has discovered new biomarkers for cardiovascular diseases, and 1Drop is collaborating with it to incorporate and test the biomarkers on its platform.
A second pharma firm is developing therapies for autoimmune diseases, including lupus and Crohn's. With the firm, 1Drop is incorporating a panel of autoimmune disease biomarkers that patients could use for early detection of flare ups, treatment using the therapies, and monitoring of the effectiveness of treatments.
The third pharma company is looking to develop diabetes therapies and wants to incorporate biomarkers linked to glucose metabolism into the point-of-care system.
The diagnostic platform is being used to assist the pharma companies in developing therapies by enabling patient selection for clinical trials, and, if the trials are successful, it will also be bundled with the therapies as a companion diagnostic used for patient selection and monitoring of effectiveness of the drug or therapy.
Cardiovascular disease testing is an interesting market, Gervais said, because of the magnitude of its prevalence, devastating effect on patients, and the potential for using a high-performance point-of-care device to diagnose patients and inform their treatments.
"A point-of-care device would enable testing as you are waiting for the ambulance and let you know what kind of problem you have," Gervais said. "Another test could be performed while the patient is in the ambulance and yet another test when the patient arrives at the hospital. If there is a need for an operating room it can be prepared in advanced as the patient is arriving at the hospital, and a clinician will have longitudinal data from the completed tests to inform decisions."
While a number of high-sensitivity troponin tests have recently received CE marking and/or FDA's OK, they need to be used with laboratory-based instruments and, therefore, take longer to produce a result than a point-of-care diagnostic test. As a result, work is being conducted aimed at developing high-sensitivity troponin tests at the point of care, including efforts by researchers in New Zealand who recently reported that an Abbott point-of-care troponin assay under development can rule out acute myocardial infarction and produce a test result in 15 minutes from a single sample with discrimination capability comparable to that of a high-sensitivity troponin laboratory assay.
1Drop has a specific roadmap and pipeline of tests under development, and it plans to continue seeking collaborations with appropriate in vitro diagnostic companies and others outside of the industry but who provide products for indications being targeted by 1Drop. Other than markers for autoimmune disease, glucose monitoring, and cardiovascular disease, the firm in the near term is developing its panel with biomarkers for thyroid, liver, and kidney function, and later for infectious diseases and oncology, Gervais said.
The characteristics of 1Drop's technology platform — a microfluidic device seeking to quickly measure a broad range of conditions from a single drop of blood — has attracted comparisons with Theranos, Gervais said.
Theranos touted a platform that could detect a host of different conditions with one finger prick of blood. After running into trouble with regulators and news reports that its tests provided inaccurate results, the company said recently that it was winding down.
"Theranos was the elephant in the room even five years ago when I was raising money in the US," Gervais said. "A lot of the experts in the diagnostic space knew [that the company would fail], so it was not a surprise to us."
1Drop, he said, is a "very different animal from Theranos." His firm is affiliated with "world leading experts in medical diagnostics and biosensors that have been working for decades in this space; published academic papers about its work; obtained thousands of citations; and is well respected in the medical diagnostics space," he said. Further, it continues to collaborate with leading hospitals, complete clinical validation studies, and be transparent about its activities.
"In the end, that means people can trust that our device actually works," he said.
Originally published here.