This story originally ran on April 14.
By Tony Fong
Leveraging technology developed in the laboratory of Harvard's George Whitesides, Claros Diagnostics is preparing to launch a microfluidic device that would allow clinicians and patients to receive test results in a fraction of the time currently possible.
The first iteration of the test is directed at prostate cancer, and, using a drop of blood, Claros' lab-on-a-chip technology can get results in less than 15 minutes — compared to several days with a conventional PSA screen.
Based in Woburn, Mass., Claros is eyeing a possible launch of the prostate cancer diagnostic in Europe in the second half of this year, and is currently conducting clinical trials in preparation of a submission with the US Food and Drug Administration to market the device in the US next year.
In addition, Claros is developing a similar device aimed at infectious diseases and is in discussions with other companies about building out the technology for other disease areas.
In an interview with ProteoMonitor this week, Claros President and CEO Michael Magliochetti said that with a pin-prick's worth of blood sample, Claros' technology can "take any centralized laboratory protein immunoassay from the reference lab to the point-of-care [setting] … using some really novel microfluidics and amplification chemistry to allow one to get a quantitative laboratory result."
The platform, he added, tests for proteins in multiplex fashion: when launched, the prostate cancer device will be able to test for four markers simultaneously, "but the technology has the capability without major modifications" to do 10 markers at once, though Claros is not actively developing the technology for that multiplexing capability.
Magliochetti said that from a regulatory-approval perspective Claros needs to go on a marker-by-marker basis for its prostate cancer device. It will first consist of the PSA biomarker as a "foundational marker,", Free-PSA and testosterone will be then be used.
"In parallel, we will incorporate other complementary markers on our platform developed by companies, with whom we are in discussions, specific to marker research," he said. "This will pertain both to additional markers in prostate cancer, including prostatic intraepithelial neoplasia, a known precursor to prostate cancer, and other urological indications such as renal cancer, bladder cancer, et cetera."
The platform operates much like a sandwich immunoassay. It consists of a blood-collecting device, a disposable cassette about the size of a credit card containing proprietary reagents, and a hand-held reader.
The disposable cassette has narrow channels containing detection chemistries "that work off light transmissions," Magliochetti said. The proprietary chemistry, combined with the microfluidics, is the secret to the technology's capabilities, he said, though he declined to elaborate, citing trade secrets.
"The less light [that] is transmitted based on the detection chemistry, the higher the concentration of the target, and vice versa," he said. "We can get down to some very, very low molecular detection with the technology." Because the technology uses whole blood as a sample, spin-down is not necessary.
Originally, Whitesides and his colleagues at Harvard University had envisioned using their technology for infectious diseases, but the focus shifted when Magliochetti got on board.
Magliochetti has extensive experience in the biotech arena and was the CEO of a number of companies such as UroSurge and HemaMetrics before becoming entrepreneur-in-residence at venture capital firm Oxford Bioscience Partners. There, he was on the lookout for new technologies with applications in urology and gynecology when he stumbled upon the technology that was being developed in the Whitesides lab.
As Magilochetti investigated further, he decided that urological applications were "right over the plate, if you will, for the technology."
OBP eventually became an investor in Claros. Other investors include Bioventures Investors, Commons Capital, and Accelerated Technologies Partners.
OBP wasn't especially interested in investing in a diagnostics company, Magliochetti said, but the applicability of the technology and the advantages it could offer over standard PSA screens was obvious. Also hard to ignore was the market opportunity that prostate cancer screening offered.
According to the National Cancer Institute, 192,280 new cases of prostate cancer were diagnosed last year, and each year about $3 billion is spent in the US on prostate cancer screening.
In the realm of diagnostic testing, ELISAs remain the standard format and Claros' technology is not meant to displace ELISAs.
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"We're not trying to be any better than the standard ELISA," Magliochetti said. "We're just trying to match that with very, very reliable results over a dynamic range that's comparable."
In particular, Claros' technology would have use for physicians who want to be able to give their patients their results during a routine office visit rather than depend on a test "where you need to go to a centralized laboratory," he said "I think it adds a tremendous amount of efficiency to the patient visit."
The potential market for Claros' prostate cancer test is more than $500 million worldwide annually, according to Magliochetti.
However, the need for such a device is unclear. According to Anthony Smith, a professor and chief of the division of urology at the University of New Mexico School of Medicine, new technology aimed at prostate cancer should be directed toward helping clinicians prognose disease progression rather than detect cancer. Already, he said, "we pick up more cancers than we need to treat."
Indeed, PSA screening has been a continual source of controversy. Because not all instances of detected prostate cancer are life-threatening, it is unclear whether a PSA test actually saves lives or whether PSA screening outweighs the risk of follow-up diagnostic tests or treatments.
Last month, the American Cancer Society added some nuance to its guidelines for prostate cancer screening to recommend that men over the age of 50 who are not expected to live beyond 10 years, because of age or poor health, not be offered prostate cancer screening because the risks associated with PSA and digital rectal exams likely outweigh the benefits.
The Prostate Cancer Foundation, however, in response to ACS' new guidelines, said in a statement that PSA screening "remains a valuable tool, in combination with other tools, for identifying potential prostate disease, including cancer. … Until new diagnostics are available, we need to guard against telling patients not to be screened."
Claros' device is not the kind of new diagnostic that would best serve patients, according to Smith. While "anything to speed up the process would be nice," ultimately, shortening the time in getting a PSA result to 15 minutes would not save any lives, he said.
Magliochetti acknowledged that in practical terms, the difference between 15 minutes and several days, or even one week, to get PSA results is not meaningful, but said that Claros' test could offer some peace of mind for a patient.
"There is a lot of anxiety among patients" during the waiting period for a test result, he said. The advantage of any point-of-care diagnostic test is that it results in more rapid and effective diagnosis and triage, leading to improved patient outcome and reduced healthcare costs.
"In this case of urology/prostate cancer, the Claros technology is a tool in the overall urologist armamentarium for a more efficient patient interaction and diagnosis or monitoring which could lead to real-time therapy decisions or adjustments, hence better healthcare management," he said.
If the prostate cancer test is successfully launched, it would serve as a springboard for Claros as it uses its technology to develop tests for other indications. The company is in discussions with unnamed companies to possibly partner to bring the prostate cancer device to the European market. It also is in the midst of a clinical trial in preparation of submitting an application for FDA approval to launch the product in the US. Magliochetti declined to provide details about the trial.
Early last year, the company closed on the second tranche of its Series A financing, raising about $4 million on top of its first tranche two years earlier for a total of $11.8 million for the round. Claros intends to launch another financing round this year to help fund the launch of the device, Magliochetti said.
In the meantime, Claros management is in the process of trying to decide how it wants to move on a similar test using the technology for infectious diseases, using "non-equity financing."
In theory, the technology can be applied to any disease for which protein biomarkers exist. "All of the work that we've done in urology, all of the pathfinding work on the development of both the disposable and instrument side, is directly translatable to new channels," Magliochetti said. "What we have is a vehicle to take [those biomarkers] from the lab to the point-of-care" setting.
He added that the technology has attracted interest from undisclosed companies with whom Claros is in discussion about forging possible partnerships to use the technology to develop other tests directed at indications such as cardiac disease, various women's health ailments, and infectious diseases.