Medical Device Link.

EMERGING IVD COMPANIES

Photo by iStockphoto

Until recently, most people believed the healthcare industry would remain impervious to the ebbs and flows of the U.S. economy. However, 2008 saw an amazing number of layoffs in the pharmaceutical industry and more hospitals struggling to keep their doors open. Healthcare reform once seemed like an option, a decision that would or would not be made. Now, the question is not, “Yes or no to healthcare reform?” Rather, it is “How will the healthcare system be reformed?” While the right answer to that question might not be on the horizon today, innovations in diagnostics are poised to be major, even if subtle, players in healthcare reform.

For example, diagnostic tests that are efficient yet inexpensive and readily available for use at the patient bedside can save a lot of unnecessary time and money spent on transporting samples and scheduling extra follow-up visits. Tests that help physicians determine the best candidate for a medication or the optimal therapeutic range can prevent adverse events and ensure that the right medication is going to the right patient, at the right dosage, at the right time, thereby cutting emergency room visits and making sure patients’ needs are met.

IVD Technology magazine’s editorial advisory board and reader board members have identified the following three emerging IVD companies as having what it takes to differentiate themselves in the rapidly growing IVD market. These companies remain on the cutting edge of medicine by providing innovative technologies that also cut costs during these tough economic times.

Claros: Bedside Blood Tests

Claros Diagnostics Inc. Location: Woburn, MA CEO: Michael J. Magliochetti Founded: 2004 Areas of Emphasis: Handheld immunoassay system for point-of-care diagnostic applications, including prostate cancer and other applications.

Founded in 2004, Claros Diagnostics Inc. (Woburn, MA) has developed a diagnostic system delivering quantitative laboratory blood test results with ease-of-use for the point-of-care (POC), said Michael J. Magliochetti, PhD, the company’s chief executive officer. The small tabletop or handheld devices make it possible to transition complex immunoassays from the laboratory to the physician’s office or patient’s bedside. “Our system consists of an analyzer and disposable cassette capable of testing for multiple biomarkers simultaneously,” Magliochetti said. “The test requires only a fingerprick of blood and yields quantitative results in less than 15 minutes.”

Magliochetti believes this new technology will change the practice of medicine for both clinicians and patients. While today patient blood samples go to a laboratory for analysis following collection, a process that takes days, the new technology will make in-office testing available to physicians without increasing costs, regulatory burdens, or staffing requirements. This technology increases efficiency by eliminating the gap between testing, receiving, and reporting results, while capturing revenue and improving patient care.

“We have gone to great lengths to understand the needs of the clinician and the patient through national surveys and focus groups, which have yielded a refined industrial design and user interface for our entire system,” Magliochetti said.

Claros’ founders, Vincent Linder, PhD; Samuel Sia, PhD; and David Steinmiller, first conceived of the core technology in the Harvard University laboratory of Professor George Whitesides. They connected with Magliochetti when he was serving as an entrepreneur-in-residence at venture capital firm Oxford Bioscience Partners. Oxford subsequently led an oversubscribed $7.8 million series A financing in January 2007 with coinvestments by BioVentures Investors and Commons Capital. In addition, Claros has put more than $3.5 million of nonequity grant financing to work on its behalf, which includes a Gates Foundation grant for use of the technology in the developing world.

When asked about Claros’ greatest strengths, Magliochetti credits the breadth of technology and the individuals behind it. “Claros’ founders originally set out to solve the very challenging problem of bringing state-of-the-art diagnostics to the most resource-poor settings in the world,” he explained. “Accomplishing this would require considering a multitude of design constraints in developing a suite of technological solutions. This same design and development philosophy is core to how Claros functions today, focusing product development on delivering simple, robust, and inherently scalable solutions.”

A handheld analyzer configuration by Claros Diagnostics Inc. (Woburn, MA).

The strengths, he said, are evident in the company’s technological aspects of sample collection, assay chemistry, onboard reagent storage and delivery, fluid control, and enhanced optics. Such strengths have coupled to create a product that can accommodate a broad range of sample media to deliver quantitative laboratory quality results quickly, and in a simple and inexpensive POC platform.

“Claros has amassed significant know-how and trade secrets associated with the manufacture of microfluidic systems that overcome the historical hurdles associated with cost and performance,” he said. “Considering all of this, I am proud of the team of individuals at Claros, all sharing the unyielding commitment and work ethic of entrepreneurs, who are executing on our original vision for the technology and the company.”

While Claros has focused on developing a diagnostic panel for prostate cancer, Magliochetti believes it will be a bridge to the true platform nature of the technology, which encompasses infectious disease, cardiology, women’s health, theranostics, etc. The company is collaborating with academic partners to develop its technology for infectious disease, initially measuring HIV, hepatitis B, and syphilis all on a single disposable test.

Claros plans to capitalize on the multiplexing nature of its technology along with its other attributes to incorporate additional markers on a single disposable test, first in their target urology market, but eventually in other fields as well. “The bottom line is that we will make the continuum of care more efficient for all of the stakeholders in the process,” Magliochetti concluded.

Corgenix: Reducing Costs without Cutting Quality

Corgenix Medical Corp. Location: Broomfield, CO CEO: Douglass T. Simpson Founded: 1990 Areas of Emphasis: Development and manufacturing of specialized diagnostic kits for vascular diseases, immunology disorders, and bone and joint disorders, including the only non-blood-based test for aspirin effect.

Founded in 1990 as REAADS Medical Products, Corgenix Medical Corp. (Broomfield, CO) is engaged in the research, development, manufacture, and marketing of IVD products for use in disease detection and prevention. REAADS specialized in enzyme- linked immunosorbent assay (ELISA) products for autoimmune and cardiovascular diseases until the company went public in 1998, changed its name to Corgenix, and began expanding its product focus.

Corgenix currently sells 52 diagnostic products worldwide to hospitals, clinical testing laboratories, universities, biotechnology and pharmaceutical companies, and research institutions. While the company’s product area focus is tests for assessing cardiovascular disease risk, it also offers ELISA products for autoimmune disease, vascular disease, and fibrosis assessment in certain liver diseases. In addition, Corgenix has a development program for rapid assays to identify certain hemorrhagic fever viruses.

Douglass T. Simpson, president and chief executive officer of Corgenix, said expertise and customer service are among the company’s greatest strengths. “We have always been very good at developing diagnostic assays that required the use of difficult molecules. Our extensive line of antiphospholipid assays and our newest test for aspirin effect are good examples,” he said. “We take pride in the quality of our customer service. We remain focused on the needs of our customers, which has helped in our success in growing even in very competitive markets.”

In recent years, Corgenix has brought several diagnostic products to the market. Of note is the company’s AspirinWorks test, which measures a urine metabolite to assess the effect of aspirin on platelets to reduce the risk of having a heart attack or stroke. “This is not an easy molecule to deal with, and it presents some significant technical hurdles in the development and manufacturing of the product, which we have overcome,” Simpson said.

“The goal in healthcare today, of course, is to reduce costs without reducing quality, and that is a tough assignment,” Simpson said. “The only practical way I see to do this is to focus on reducing the incidence of the most severe and most expensive events, rather than reducing the quality of the care of the patient.”

One example is the cost of having a heart attack. In the United States, when a hospital admits a patient with severe chest pain, that patient undergoes expensive tests and procedures, such as cardiac catheterization with drug-eluting stents, a procedure that can cost $100,000 on the first day. Then there is the long-term treatment to consider.

“We can’t say don’t use the drug- eluting stents because they are too expensive, or don’t use the latest cardiac catheter lab equipment, or even, let’s minimize long-term drug therapy to keep the vessels open,” Simpson says. “What we must do is reduce the number of heart attacks by implementing better preventive medicine.”

The AspirinWorks ELISA kit by Corgenix Medical Corp. (Broomfield, CO), a non-blood-based test for aspirin effects.

More than 64 million Americans take a daily aspirin to reduce the risk of heart attack or stroke. “Statistically we know that in up to 25% of individuals, the aspirin is not sufficiently effective in reducing platelet clumping,” according to Simpson. “From the IVD side, AspirinWorks can help to detect those individuals early, before the heart attack occurs, and give the physician the opportunity to take a more aggressive preventive approach.” For a cost of a few hundred dollars, Simpson hopes this technology will prevent many of those $100,000 days.

Corgenix works continuously on new tests for its cardiovascular disease marker program. “A large part of our development program today is our AtherOx technology, a patented biomarker consisting of oxidized LDL and beta-2 –glycoprotein 1,” Simpson explained. “We already have one product in this group that FDA has cleared, the IgG anti-AtherOx product, and we have several others in clinical studies. Our hope is that these markers eventually become recognized as important biomarkers for determining risk of cardiovascular disease, which again will lead to reducing healthcare costs.”

Simpson said that the IVD industry is a particularly interesting field to work in because it is possible to bring innovative tests to market in just a few years. “I envision that some day we will see healthcare providers mandating wellness and preventive medicine efforts for all of their insured,” he said. “With the changes we will see in the near future to reduce overall costs, the importance of IVD companies will only increase.”

Osmetech: Getting the Dosage Right

Osmetech plc Location: Pasadena, CA CEO: James White Founded: 1993 Areas of Emphasis: Molecular diagnostic testing with electrochemistry-based assay system with in vitro test for cystic fibrosis carrier detection and warfarin sensitivity test.

Originally founded in 1993, Osmetech Molecular Diagnostics (Pasadena, CA) created a molecular diagnostics division in 2004, which is where its focus lies today.

Osmetech’s goal is to transform molecular diagnostics into cost-effective testing solutions that make sense for clinicians and patients. The company focuses on greater simplicity and flexible testing capabilities so that a wide range of hospitals and laboratories can access technologies that allow them to provide diagnostic services to their patients.

Of interest now is the first application of Osmetech’s second-generation eSensor XT-8 System technology, a multiplexed genotyping system for clinical diagnostic and pharmacogenomic testing currently used for warfarin sensitivity testing. Warfarin is an anticoagulant with a very narrow therapeutic range that is difficult to control. About 20 million people in the United States are on warfarin at any given time. After insulin, it is the most common drug to result in emergent adverse drug events, and estimates indicate that warfarin causes 85,000 serious bleeding events and 17,000 strokes in the United States each year.

Therapy with this commonly prescribed blood thinner is challenging to initiate, and once at an appropriate therapeutic range, it requires careful patient monitoring since a dose that is too high can lead to excessive bleeding. Additionally, patients vary considerably in the dose they need to achieve the greatest therapeutic benefit. Most importantly, warfarin testing can save the lives of people with a genetic predisposition that can cause adverse drug reactions, including death.

Scientists have determined that the basis for variation in warfarin sensitivity is due to an individual’s genes. The eSensor warfarin sensitivity test is capable of genotyping three polymorphisms in two of the genes shown to relate to individual warfarin sensitivity. The test aims to pinpoint individual variations in such a way that makes achieving a therapeutic dose more efficient and safer. FDA approved the first Osmetech test identifying three biomarkers associated with warfarin metabolism in July 2008. As an added benefit, because of the simple eSensor XT-8 platform, patients can undergo genetic testing in the clinic, and clinicians can receive information about warfarin sensitivity in a few hours.

The eSensor XT-8 System by Osmetech Molecular Diagnostics (Pasadena, CA).

The new system and a specific focus in molecular diagnostics make Osmetech unique in the IVD space. “Successful commercialization of the first generation of the electrochemical multiplexing system eSensor 4800+ cystic fibrosis assay (ACOG 23) was the foundation for the new eSensor XT-8 plus multiplex assays,” a company spokesperson said. “The eSensor XT-8 is gaining market adoption due to its user-friendly design and assays that work.”

The company also prides itself on its technology’s application of electrochemical multiplexing for detecting DNA, RNA, and protein. That is important because earlier multiplex technologies could only analyze a few polymorphisms in a single test. With multiplexing, it is possible to determine a much higher number of genotypes simultaneously.

Osmetech endeavors to solve many of the problems facing customers in the diagnostics field today. Its technology works for customers that want small-footprint instruments when doing molecular testing, and simplified platforms for adoption in labs that have less experience with molecular testing. The company provides such devices, plus a true random-access system to molecular laboratories to allow optimal production efficiency to meet small or large laboratory test volume requirements.

“Osmetech’s core technology is robust and provides users with confidence that the results they are reporting are credible, reliable, and reproducible with best-in-class instrument and multiplex design. This technology will allow us to bring molecular testing to any site, anywhere, powered by electricity, even batteries,” a company spokesperson said. “The vision for the not too distant future is a point-of-care system providing sample-in and answer-out capabilities in a small, hearty, user-friendly format.” Osmetech’s growing menu of medically pertinent tests is also noteworthy. “For these reasons, the future for Osmetech is very bright and exciting.”