Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News
Test Developers Aim for Smaller Footprints and Lower Prices
Spartan Bioscience is gearing up to launch what it calls the world’s smallest commercial molecular diagnostics device, a coffee cup-sized portable testing tool called the Spartan Cube.
Should the Cube live up to its vision of enabling anyone to quickly perform DNA testing, as the company declared May 31, it could further disrupt an already-growing market for point-of-care molecular diagnostic tests—a market that is projected to more-than-triple to $3.9 billion by 2024, up from $1.2 billion last year, according to Grand View Research. Rosy forecast aside, point-of-care molecular diagnostics still face numerous challenges that threaten to slow down the expected future growth and lessen its odds of widespread adoption by healthcare providers.
Those challenges should be overcome, Grand View noted, through growing demand for POC molecular diagnostics (MDx) usable outside laboratory settings, such as pharmacy clinics, physician offices, and home care; continued funding of new technologies by developed countries and private sources; and ongoing R&D to miniaturize molecular diagnostics. Spartan’s Cube, for example, is just 4 inches cubed.
“Spartan’s vision is bringing the power of DNA testing to everyone and we believe the Cube will do that,” Spartan CEO and founder Paul Lem, M.D., told Clinical OMICs. “Our initial test menu focuses on the infectious disease, pharmacogenetics, and food and water testing markets. But as a platform technology, these are just three possible applications out of many.
The Cube is a PCR-based platform designed to go from sample to result in 30 minutes. The Cube will be launched next month at the American Association of Clinical Chemistry (AACC) meeting in Philadelphia, and made available for purchase soon after. Spartan has not disclosed the Cube’s price, but says it will be significantly less than the $10,000 to $50,000 cost typical of DNA testing devices.
“The Cube will be affordable like a personal computer,” Lem said. “In the same way that mainframe computers gave way to personal computers, high-throughput DNA testing systems in central labs will give way to portable, on-demand DNA-testing systems.”
Also emphasizing size has been Cepheid, which in July 2015 announced plans for “the world's most portable molecular diagnostics system,” the GeneXpert Omni for Point of Care. GeneXpert Omni will cost $2,895 and run the same PCR-based cartridge tests as Cepheid's existing GeneXpert systems.
The 9-inch-tall, 2.2-pound GeneXpert Omni was expected to be available in emerging markets outside the United States in the first half of this year. However, on April 28, Cepheid Chairman and CEO John L. Bishop told analysts the expected delivery date had been pushed back, to “no later than the third quarter 2017.” He said the extra time would ensure the system’s detection and amplification module or “I-Core” was fully functioning “such that it will address both our current and future test menu.”
“There is a possibility that we will be able to complete development and enter the market sooner,” Bishop added.
Asked whether that possibility has grown or diminished since April, Katherine Chen, investor relations analyst with Cepheid, said “we continue to target Q3 2017 for the launch of the Omni outside the U.S.” Chen added that Cepheid has not updated its test menu since announcing the delay. That menu is expected to include Xpert MTB Ultra, Xpert HIV-1 Qualitative, Xpert HIV-1 Viral Load, Xpert HCV Viral Load, and Xpert Ebola.
POC Market Movers
Advancements in technology have helped drive increased POC use in recent years, Harry Glorikian, senior executive, board director, and consultant in the life sciences/healthcare industry, told Clinical OMICs. Other drivers, he said, include the Affordable Care Act and business models that have worked outside healthcare.
Cepheid, for example, has a “razor and blades” model that sells systems for less, recouping lost revenue through repeat sales of supplies. Last year, Cepheid’s clinical reagent sales grew 20 percent, to $426.9 million, more than three-quarters of the $538.6 million in total sales—and more than making up for a 2 percent loss in clinical systems sales, which generated $83 million.
Global leader Roche, which expanded into the POC market in 2014 via its acquisition of IQuum for $450 million, generated $11.2 billion in diagnostics sales last year, including $1.8 billion in molecualr diagnostics.
Earlier this year, Abbott envisioned topping the POC field through a $5.8 billion acquisition of Alere. That transaction’s fate is uncertain; Alere in April rejected Abbott’s up-to-$50 million offer to end the deal, after Alere was subpoenaed by the U.S. Department of Justice over payments and practices in Africa, Asia, and Latin America.
Challenges to Adoption
Given the expense, health providers need to generate a sufficient volume of tests to justify acquiring molecular diagnostics systems, especially for POC testing. That need is among the challenges to point-of-care adoption, according to Gyorgy Abel, M.D., Ph.D., director of clinical chemistry, molecular diagnostics, and immunology at the Lahey Hospital & Medical Center in Burlington, Mass.
Another challenge, he said, is the fact that reimbursement is the same for POC and lab versions of the same tests, if they otherwise use the same or similar technology. Yet the cost per test processed by central labs is less than that of point-of-care tests. Molecular PCR-based tests requiring central labs can range from $10 to $25, or even less, compared to the $40 to $50 range for a cartridge-based POC tests.
“If you add labor and other overhead, you basically are going to lose money,” Abel observed.
Sarah Brown, Ph.D., DABCC, co-medical director, Core Laboratory: Clinical Chemistry, and director of ancillary services at St. Louis Children’s Hospital Clinical Laboratories, said that technology poses another challenge to POC.
Brown, treasurer of AACC’s Critical & Point of Care Testing Division and an assistant professor at Washington University School of Medicine in St Louis, noted that in several PCR-based systems, samples may require multiple steps of preparation or more sensitive handling than can be accomplished in non-lab settings, noted.
The most important consideration, Abel said, “is whether there is a real clinical need for rapid and accurate diagnosis, and whether it will change the treatment and improve the outcome.” For conditions that patients have lived with for years, he said, providers see no urgency for POC testing. He anticipates that will change in the U.S. as reimbursement shifts from fee-for-service.
“If we get paid a fixed amount of money for the treatment of a certain condition, a judiciously used point-of-care test may eliminate an unnecessary second appointment. But, currently, we rarely have the incentive to do that,” Abel added.
While core labs won’t disappear, Abel said, the growing need to combat antibiotic resistance will help propel future growth in POC testing. As a result, POC is likely to grow in emerging markets, where limited resources and local conditions make traditional lab-based testing less practical, both Abel and Brown agreed.
“I want to be able to put something in my backpack, and take it with me into Haiti,” said Brown, who has taught clinical laboratory management to laboratory technicians there as assistant director of clinical pathology for Pathologists Overseas. “We’re still not there, for sure. But I can put a BioFire in my truck and drive it down to a rural clinic and set it up without any problem. So, I think we’re definitely moving in the right direction.”
In the November 2015 issue of The Lancet Global Health, Paul K. Drain, M.D., MPH, FACP, of the University of Washington, and Nigel J. Garrett of the Centre for the AIDS Programme of Research in South Africa (CAPRISA) highlighted three challenges to POC adoption in remote, resource-limited settings: Ensuring oversight for maintaining the integrity and accuracy of diagnostic testing; assessing the effect of point-of-care testing on labs; and criteria for adoption of novel point-of-care tests.
“I don’t believe any progress has been made since our paper was published,” Drain told Clinical OMICs. “There continues to be demand for molecular POC tests from providers in the clinics, but a general reluctance on the part of lab managers to have ‘complex’ testing performed outside of the controlled lab environment.” He and colleagues will soon launch a study evaluating clinic-based HIV viral load testing: “The test should be accurate enough to have a meaningful clinical impact, and we hope to disprove the notion that these tests are too cumbersome to be conducted at the clinical POC.”
Drain said the World Health Organization should take a leading role on guiding implementation of POC testing rather than leave that to individual programs: “It is expanding rather quickly, so inaction will only cause more issues down the road.”
This article was originally published in the July 2016 issue of Clinical OMICs. For more content like this and details on how to get a free subscription to this digital publication, go to www.clinicalomics.com.