Guava Technologies said this week that it has received 510(k) clearance from the US Food and Drug Administration to sell its EZCD4 cellular analysis system in the US for identifying and quantifying CD4+ lymphocytes in whole blood to monitor HIV-positive patients.
The company hopes that the benefits of its microfluidics-based technology — that it is less expensive, requires less sample, makes less reagent waste, and is easier to use once a technician has been trained — will help it overtake existing methods, which have multiplied over the past decade since HIV became a chronic disease for most patients.
The FDA approval reinforces the use of the test by Guava's existing international customers, and may boost sales of the platform outside the US, according to a company official. Furthermore, the FDA clearance may attract US diagnostics shops with which Guava hopes to partner for diagnostic applications beyond CD4 testing.
However, Guava will not immediately sell the product in the US for CD4 testing because the market is primarily international, Lalit Dhir, vice president of corporate development and strategic marketing for Guava, told CBA News this week.
"Having this FDA clearance will definitely boost our revenues ex-US, because a lot of organizations had said, 'It would be great if you had FDA clearance, because other companies do.' So it will definitely help us win more business in Africa and Southeast Asia."
"There are no immediate plans," Dhir said. "We also have some other processes that are in the works, and once those are completed over the next several months, then we'll come back and make a decision. But if you look at the worldwide market, most of the market is outside the US and Western Europe."
Dhir said that FDA review of the product was "rather expedited," as Guava had only filed for clearance in December.
"The FDA showed a lot of interest, a lot of diligence, and worked with us, and we worked with them to provide whatever information was needed, at a remarkable speed," Dhir said.
Guava's EZCD4 system comprises the actual assay reagents, the company's flagship Personal Cell Analysis (PCA) instrument, and CytoSoft v2.3 software that incorporates modules entitled EZCD4, Guava Check, and Clean and Shutdown.
Guava also sells the PCA instrument to the academic and industrial drug-discovery research markets. Essentially, the EZCD4 system is based on the exact same instrument — a bench-top microfluidic flow cytometer — but with different software.
"When you look at the Guava platform, there are a number of advantages that are suitable for diagnostic applications — primarily, the small sample size needs," Dhir said. "Secondly, the ease of use — when you talk about trained technicians, Guava needs less than half a day of training, and you're up and running."
Other features that Guava hopes to promote to potential diagnostic partners could also be attractive to academic and industrial drug-discovery labs. These include the small physical size of the instrument, and reduced reagent waste due to the microfluidics technology.
"We wanted to show our potential partners that the Guava technology — the microcapillary cytometry tech in general — though it's relatively young, has the capacity to get FDA clearance, so that they can pursue other applications with us, which would likely [need to] be FDA cleared also," Dhir said.
"We are looking to partner our technology with other diagnostic players who have assays that would work on the Guava system, or, for some reason, their current system doesn't deliver what they are looking for," he added. "Most" of these assays would be around cell analysis-based applications, and they could be for many different disease areas, he added.
Several disease areas outside HIV exist, Dhir said, and oncology is one of the most attractive to potential partners. Other possibilities include testing for human papillomavirus and other HIV-related complications. Dhir declined to elaborate because Guava is currently in discussions with potential partners for these areas.
News of the FDA approval, or that Guava was even seeking it, came as somewhat of a surprise. Few people were expecting the company to come out with an FDA-cleared diagnostic, even though it made a splash in that market in May 2004 when it launched the EZCD4 system for T-cell enumeration in markets outside the US, Europe, and Japan, where regulatory clearance would not be necessary.
At the time, it played up the advantages of the system over existing products — namely, that it could enable as much as a 20-fold reduction in the cost of individual blood tests — and said that it would eventually seek FDA approval for the platform (see CBA News, 5/11/2004).
However, there seemed to be some disagreement in upper management about the practicality of putting too many eggs in the diagnostics basket, and possibly neglecting the potential of Guava's instruments for basic and drug-discovery research. This culminated in February 2005 with the resignation of then-CEO Rajen Dalal (see CBA News, 2/8/2005 and 7/25/2005).
Later that year, Guava appointed as CEO Lawrence Bruder, closed a $7-million financing round, and said it would re-focus its resources on marketing its microfluidics-based cellular analysis platforms to the basic academic research and industrial drug-discovery markets (see CBA News, 12/5/2005).
This week, Dhir reaffirmed with CBA News that the company is maintaining its focus on the basic and drug-discovery research markets despite the FDA clearance of EZCD4.
"Over the last year or so, and … when new management came on board, we made a decision that we would focus mostly on industrial drug-discovery and academic research," Dhir said. "As far as diagnostics are concerned, we made the decision to pursue opportunities to partner out our technology to organizations or businesses that are interested in taking advantage of the Guava platform for specific applications. That still is the case."
In December, Guava also said that it would not completely ignore the potential of its technology in clinical diagnostics, and the clearance of EZCD4 is an example of that.
"The CD4 system is an exception, because we've had a lot of positive response from customers … mainly because of ease of use and affordability," Dhir said. "These are especially important when you talk about the market outside the US and Western Europe. We wanted to make sure that if we have some product out there that we don't ignore it."
Many of Guava's existing customers for EZCD4 are in Africa and Southeast Asia, Dhir said, and many of them have requested that Guava obtain 510(k) clearance to at least validate the technology by proxy.
"Although we don't sell it in the US and Western Europe, it's meant for diagnostics, and we wanted to make sure the customer feels this is a high-quality product," he added. "Having this FDA clearance will definitely boost our revenues ex-US, because a lot of organizations had said, 'It would be great if you had FDA clearance, because other companies do.' So it will definitely help us win more business in Africa and Southeast Asia."
Guava may eventually attempt to market the product in the US for HIV patient monitoring, but that currently is not a priority, according to Dhir.
— Ben Butkus (bbutkus[email protected])