Two European diagnostics companies that have developed a diverse set of array-based tests last week announced that they had received or are awaiting CE-IVD marking for their products, and discussed their plans to sell those tests globally.
Helsinki, Finland-based Mobidiag said that its Prove-it array-based in vitro diagnostic for Sepsis has met the requirements for CE-IVD marking and can now be sold to clinicians in Europe. The company also plans to eventually pursue US Food and Drug Administration clearance for its test.
Meantime, Oslo, Norway-based DiaGenic announced a partnership with Belgium’s DNAVision to provide two gene expression-based tests for breast cancer and Alzheimer’s disease detection in Europe. Like Mobidiag, DiaGenic also has plans to sell in the US, but unlike Mobidiag, the company is gearing up to soon offer its tests in another large market: India.
According to some experts, molecular diagnostics companies like Mobidiag and DiaGenic are increasingly weighing their options about the regulatory route they should pursue to begin commercializing their products in different geographic regions.
While US test makers still prefer to clear their assays through the FDA and Europeans tend to seek CE markings first, companies are increasingly looking for alternative paths to market that may take them to India or China before they hit the EU or US.
In Mobidiag’s case, it decided to pursue a CE-IVD marking for its Prove-it Sepsis test, which enables researchers to simultaneously identify 50 bacterial species on the firm’s TubeArray platform in less than three hours.
The seven-year-old company said last week that it had met the requirements of European directives governing CE-IVD marking after completing a 3,300 patient study in the University College London Hospitals and the Hospital Districts of Helsinki and Uusimaa in Finland.
CEO Jaakko Pellosniemi told BioArray News that Mobidiag’s initial target customers will be larger clinical hospitals in Europe. He also said that Mobidiag “eventually” wants to pursue US Food and Drug Administration clearance for Prove-it Sepsis. He did not elaborate on a timeline.
Pellosniemi said that Mobidiag made the choice to pursue CE-IVD marking because of its quicker route to market. “Within the European Union … it is the responsibility of the manufacturer to ensure that the IVD product conforms with the relevant directives and standards,” Pellosniemi said.
“As soon as the manufacturer has the proof of the performance and reproducibility with patient samples, established manufacturing processes, and appropriate [quality management systems] in place, the CE-IVD product can be put out to the market,” he said.
Pellosniemi said that the process for getting a nod of approval from the FDA “takes from several months up to more than a year, and consumes resources. For a European company it is an obvious choice to go for the CE-IVD first and then start the FDA process.”
Meantime, DiaGenic CEO Erik Christensen said his company expects its BCtect test for breast cancer and its ADtect product for early-stage Alzheimer’s detection to receive CE marks in early 2009, after which they will be offered as a service through DNAVision.
He also said that the company plans to eventually submit its tests for FDA clearance. ”This is the natural and shortest market route for us since we are a European company,” he told BioArray News this week. ”Naturally we are looking for FDA clearance and we already have had positive dialogue with them over their exact requirements for what will be a new kind of test.”
While DiaGenic gears up for a European play, a launch in India could come before the end of the year. In May, the company announced that SRL Ranbaxy, a clinical reference pathology lab network based in New Delhi with 40 labs and around 750 collection centers, would market BCtect in the Indian market (see BAN 5/27/2008).
DiaGenic ”found India the ideal place to conduct a large-scale clinical trial for our breast cancer test because of the wide ethnic diversity and excellent CRO networks available,” Christensen said. He said that breast cancer is a ”big and growing problem” in India with some 250,000 new cases predicted per year by 2015.
”The market potential is substantial even for a relatively expensive test with very rapidly growing middle class,” Christensen said.
A ’New Situation’
The fact that DiaGenic’s BCtect test may become available in India before Europe or the US is part of an emerging trend among molecular-diagnostic makers opting to take their product to market — wherever that market may be — and via whatever channel they deem best, be it directly or through distributors.
According to Harry Glorikian, a managing partner at Boston-based life-sciences consultancy Scientia Advisors, while the idea of an American test maker pursuing a CE marking before taking an assay through the FDA is not new, the presence in the equation of emerging markets like India and China is.
”These sets of questions can make or break companies.”
”I think that this situation is a little new in a sense,” Glorikian told BioArray News this week. ”Remember that these markets are new; 10 years ago, China and India were not what they are today,” he said. ”Now that they have a rising GDP and an emerging middle class, the services are available and the market has been created. And these markets don’t want a second generation or a cheaper technology; they want something more,” he added.
And just as the various new channels to market are presenting themselves, companies developing array-based tests have been faced with a variety of new questions, Glorikian said: ”What is the assay, how big the market is, and where the companies want to place their bets,” he said. ”These sets of questions can make or break companies.”
Glorikian said as much in a separate interview with BioArray News last week when he predicted that the US will continue to be the ”biggest market” for array-based tests, but that it might make more strategic sense for these companies to enter ”somewhere else and then swing back to the US.”
”It all depends on what you are looking for, how the indication is going to be used, and how it is going to be used,” he said last week. ”If it is going to take an act of God [for a test] to clear the FDA, you may want to enter another country first, generate revenue and data, and then take it to the FDA. Or they may choose not to take it through the FDA altogether, and stay out of the [US],” he said. ”It’s definitely not one size fits all” (see BAN 10/28/2008).
When it comes to launching molecular diagnostics, most firms preparing to launch array-based tests believe that it is necessary to serve not just Europe or the US, but also Asian markets, like India, China, Japan, and Korea.
DiaGenic’s Christensen echoed this sentiment, saying that the firm will seek ”other market opportunities” following the expected CE marking of its tests. ”We will focus on markets with a high private payer segment where we also can utilize our testing facilities in India and Belgium,” he said.
For Mobidiag, Pellosniemi said that the firm’s products are “well suited for all laboratories capable of running PCR-based assays” and predicted that, “once our distribution channels are in place,” the company plans to target markets in the Middle East such as Turkey; the Far East, Indonesia, and Thailand; and Australia and New Zealand.
Exiqon is also looking to move beyond the EU and US. The company is planning to develop a colorectal cancer recurrence-detection test and make it available through its Clinical Laboratory Improvement Act-compliant lab in Tustin, Calif., by year end. Lars Kongsbak, CEO of the Copenhagen, Denmark-based shop, told BioArray News last week that, in regards to China and India, it is ”clear” that Exiqon needs to sell its future tests there.
”It is not only for the sake of the cancer patients,” Kongsbak said, ”but also because the investments into developing a diagnostic product dictate that we eventually offer the products to a broader market than the US market.”
For its part, Pathwork Diagnostics, headquarterd in Sunnyvale, Calif., earlier this year received FDA clearance for an array-based test designed to identify tumors of origin in cancer patients. The firm has decided to attack the American market by both selling FDA-cleared kits and, like Exiqon, offering its test as a service through its CLIA lab.
Still, Shawn Becker, vice president of marketing and reimbursement at Pathwork Diagnostics, told BioArray News this week that the company also has global ambitions for its TOO test. Becker said that the firm will definitely seek CE-IVD marking for the product, and that it is ”not yet disclosing our plans except to say that in its initial phase especially in India, China, and Japan, it will likely be through distributors.”
However, while interest in serving the Chinese and Indian markets may exist among most array-based test makers, several companies interviewed said that regulatory issues may discourage them from bringing their products to Japan.
”Japan has a very strict regulatory system and is therefore not the first on the list,” DiaGenic’s Christensen said. Scientia’s Glorikian agreed, saying that, ”everybody knows that Japan’s reimbursement system is not what it should be. A lot of [molecular diagnostics] companies go to Japan because they have to, but not because they want to do it,” he said. ”It’s a good market but I have heard complaints about the way reimbursement is set up right now.”