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Alere Officials Discuss Advantages of POC Platform as Firm Shifts Focus to MDx

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NEW YORK (GenomeWeb) – Diagnostics firm Alere is in the midst of reorienting itself in the market as it shifts some of its attention from its lateral flow immunoassay-based diagnostics business onto its newly CLIA-waived point-of-care nucleic acid detection platforms, Alere CEO and President Namal Nawana said yesterday.

Speaking on a conference call after the firm reported that its fourth quarter revenues fell 1 percent year over year, Nawana said Alere is "more and more focused around rapid molecular diagnostics. … We reoriented very quickly a few months ago, and we are pleased that we're making progress. Overall, I'd say that molecular diagnostics at the point of care is something that is transformational in diagnostics, and we're focused around really moving toward that area."

Alere's efforts in the molecular space began in 2012, when it acquired TwistDx and Ionian Technologies. The firm has since developed the isothermal nucleic acid amplification chemistries that came along with those acquisitions into two molecular platforms suitable for near-patient nucleic acid amplification testing, called the Alere i and Alere q.

The Alere i was CE marked and launched in Europe in early 2014 and cleared by the US Food and Drug Administration in June. The first test for the platform – a 15-minute assay that detects influenza A and B virus DNA from patient nasal swabs – was cleared along with the platform, and a few weeks ago the Alere i flu test became the first ever point-of-care molecular test granted CLIA waiver for use in low-complexity settings.

While the flu MDx market is quite crowded, as recently reported by GenomeWeb, the time and cost savings of such a rapid test has potential advantages. And even before the CLIA waiver, in October of last year Alere won a $12.9M contract from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority to fund a next-generation version of the Alere i platform and flu test as part of pandemic influenza preparedness. 

Keith Stauffer, Alere's vice president of marketing for rapid diagnostics, told GenomeWeb last month that the firm is now ramping up production of the Alere i platform, which is manufactured in Maine, and that it intends to develop relationships with low-complexity pharmacy-based clinics and similar locations now permitted to run the test.

Thus, CLIA waiver expands Alere's sales maps, adding new territories in which to market. "Clearly we open up to thousands [of new sites] – on paper it's tens of thousands – I'd say in terms of volume … if we get to several thousand it's a great opportunity for us already," Nawana said during the call. He added that the hospital opportunity in emergency departments is also very important. "I think we'll actually do well in both sectors," he said.

Nawana, who was appointed three months ago after a shakeup at the company, further explained that the company plans to market the Alere i platform and test menu as part of a package of testing and analysis products. In a follow-up email, Dave Teitel, Alere's CFO, elaborated on this plan, which the company has dubbed "Leading Solutions," for the US hospital market.

"Customers who purchase packages of our instruments can get special incentives, and [they] benefit from the ability to partner with a single vendor that understands point-of-care diagnostics; the packages include various combinations of our Triage [rapid immunoassays], epoc [mobile blood tests], Alere i systems, and RALS [clinical informatics] connectivity," Teitel said.

International placements of Alere i platforms have been outright sales, while the US placements have mostly been "reagent rentals" thus far, Nawana said in response to an analyst's question during yesterday's call. Alere's respiratory product manager previously quoted a platform price of $8,500 and a cost per test of around $80, as reported by GenomeWeb.

Furthermore, despite the fact that CLIA waiver came well into the influenza season, when "the bulk of flu season stocking was completed … Alere i generated nearly $1 million in sales in Q4 of 2014, and as of today [we have] installed more than 500 platforms with an additional 100 platforms in evaluation in the US and internationally," Nawana said.

One customer bought 50 platforms at once, he claimed, emphasizing that this kind of bulk purchasing for an entire network of users will be a future target of Alere's marketing and sales teams. In the few weeks since CLIA waiver, "We just didn't have enough time to get a lot of key accounts like that, but there is an appetite for people to really make a decision for their system and to benefit from that full system approach," he said.

The sales pitch for the Alere i is "molecular in minutes," hyping the sensitivity and specificity of nucleic acid-based assays and the 15-minute test time versus competitors' molecular tests, which take "well over an hour." Nawana also asserted that the firm has "an instrument which is … much less expensive than any other molecular diagnostic platform."

Another benefit to customers is the reimbursement rate for the FDA-cleared test, Nawana noted. It is "triple" that of a lateral flow flu test, which is reimbursed at about $30, although this currently varies by state, he said. The company will continue to sell both kinds of test, though, because "there is always going to be a mix of which asset is used in which circumstance."

The flu season appears to have peaked and is now declining, Nawana said, and "whether or not it declines dramatically from here, or goes slowly, will directly influence our Q1 results." When the next flu season breaks out, likely during the third quarter of this year, the firm expects it will get more feedback on whether customers appreciate its "molecular in minutes" approach.

"We feel very good about the value proposition that we have with respect to all molecular diagnostics platforms, and then, of course, being the only molecular diagnostic platform with CLIA waiver, we're able to go where others really can't," Nawana said, adding, "I think we've had fantastic feedback so far; obviously, it was very late into the flu season to get the CLIA waiver and so in Q3 we anticipate really a great building on that platform."

He also emphasized the company's "aggressive plans" to continue test menu development for the Alere i.

"We've had Strep A with the agency for quite some time, and … we feel that Strep A is something we'll see, let's say, in the first half of this year," he said. Development of other menu items, including RSV and Clostridium difficile tests, has been "accelerated," he said. The firms rapid, point-of-care, molecular chlamydia test, meanwhile, "is something that could be really helpful, particularly in the GPs office," Nawana said, a sentiment echoed by a number of clinical end users who, in interviews with GenomeWeb, have described a potential CLIA-waived chlamydia and gonorrhea test as a "game changer" for public health.

Nawana also restated the company's previously reported timeline for the Alere q platform. It "will have a limited launch this year for early infant diagnosis of HIV in Africa, and we expect sales from that," he said.

A recent study in Mozambique showed the viability of the Alere q HIV 1/2 test for accurate and rapid point-of-care HIV diagnosis in infants. The firm previously stated that it had submitted for World Health Organization prequalification for this test and it plans to begin commercial sales in 21 high-prevalence countries in Sub-Sahara Africa in the first quarter of 2015, with sales in Europe andAsia to follow in the second half of 2015.

The Alere i and Alere q platforms are based on the firm's recombinase polymerase amplification (RPA) and nicking enzyme amplification reaction (NEAR) isothermal nucleic acid amplification technologies. The RPA chemistry is still sold by TwistDx, and was recently used by researchers at The Royal Tropical Institute in Amsterdam to detect pathogens that cause leptospirosis and by researchers from the University of Potsdam and the Fraunhofer Institute for Biomedical Engineering in Germany to detect the parasite that causes malaria. It also was used by researchers at the University of Southampton in the UK to develop a miniaturized chip-based C. difficile test. In addition, it has been developed by researchers at Rice University in Houston into a quantitative assay, and a proof-of-principle study, also by researchers at Rice, showed it could be used to detect HIV using only heat from a person's underarm.

RPA was the amplification chemistry of choice for early infant diagnosis of HIV in a recent study and is reportedly being developed into a diagnostic for low-resource settings. Still another study recently demonstrated that RPA could be used to detect single nucleotide polymorphisms, pointing toward the possibility of isothermal personal genomics and companion diagnostics testing.

Teitel further noted that Alere has "licensed certain of the technologies that we acquired in connection with the TwistDx acquisition to third parties for use by them in high-volume sequencing applications."

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