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With CLIA Waiver and Widespread Flu, Alere Ramps Up Molecular Test Production

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NEW YORK (GenomeWeb) – In emergency rooms and physician's offices, lateral flow immunoassays are often used when rapid results matter for patient outcomes. Nucleic acid amplification tests are usually more specific and sensitive, but require laboratory technicians, and the very fastest US Food and Drug Administration-approved tests still take about 90 minutes.

Now, a 15-minute molecular influenza test on the Alere i platform has received CLIA waiver, allowing rapid molecular testing in low-complexity settings and potentially providing clinicians the best of both worlds.

As the FDA noted in a statement, this test is the first nucleic acid-based test ever to receive CLIA waiver. 

The waiver "opens up a significant new opportunity for [Alere] within the physician office market," Keith Stauffer, vice president of marketing for rapid diagnostics at Alere, told GenomeWeb.

This is particularly true for influenza testing. "Sixty percent of flu testing is done in the physician's office market, and about 80 percent of that market is CLIA waived," Stauffer explained. Waiver opens up pharmacy-based health clinic settings to the test as well.

Early in the current flu season, Ebola fears may have prompted physicians to look into flu testing options, but that has dissipated, Stauffer said. However, given that the influenza vaccine only provides partial protection this year, the US Centers for Disease Control is warning that this season could be severe, and is already widespread in 43 states. This may give the firm reason to expect increased demand.

"We work very closely with our end-user customers, our distributors, and our manufacturing to make sure that we stay on top of that and manufacture to the needs of the market," Stauffer said. "We have put additional personnel in our manufacturing facilities to make sure that we continue to meet the demands."

Alere is based in Waltham, Mass, but the Alere i Influenza A & B test is manufactured by Alere Scarborough, Inc., located in Scarborough, Maine, according to an FDA statement.

The Alere i platform uses a nicking enzyme amplification reaction (NEAR) chemistry that Alere acquired in 2010 along with Ionian Technologies. The platform also has the potential to use recombinase polymerase amplification (RPA) chemistry that the firm acquired with TwistDx. The platform launched in Europe this past January, and was cleared by the FDA in June. The firm won a $12.9 million BARDA contract in October to develop a low-cost next-generation version of the platform for pandemic influenza.

Alere is best known as a maker of immunoassays for clinical use, and it has an established distribution network for products like its Binax tests. Indeed, in an interview with Genome Web when the Alere i platform launched, KC McGrath, respiratory product manager at Alere, asserted that the company sells more lateral flow flu tests than anyone in the world, adding "we'll continue to do that — there's a place for them, and they work really well."

Thus, it is unclear to what extent the Alere i flu test will cannibalize Binax flu test sales.

"We have a lot of satisfied customers for Binax … if they are looking to move up to a molecular format that gives the same rapid response, then it's a perfect opportunity for them to convert to a more sensitive technology," Stauffer said.

Alere's newly-appointed CEO and president, Namal Nawana, noted in the firm's third quarter earnings call in late October that he believes there may ultimately be a "mix shift" in flu testing. "The reimbursement is obviously dramatically different for molecular flu versus lateral flow, so I think customers will choose a mix and we will see that settle over time," he said.

The Alere i flu test was initially launched by both Alere's hospital- and physician's office-focused sales teams, Stauffer said. With CLIA wavier, "the opportunities within both of those channels will now increase,'" he said.

The company can now also make this test available to clinics in pharmacies, Stauffer noted. "We would have to enter into some negotiations and contracting — with CVS, for example, we do have some relationships at the corporate level there — and we'll be following up with those types of opportunities," he said.

To obtain the CLIA waiver, the firm had to demonstrate "ease of use and low risk of false results when used by untrained operators," according to an FDA statement. Alberto Gutierrez, director of the Office of In Vitro Diagnostics at FDA's Center for Devices and Radiological Health, said in the statement that the agency expects "many other simple and accurate tests using nucleic acid-based technology to be developed in the near future." Once these are cleared by FDA, "such tests can allow healthcare professionals to receive test results more quickly to inform further diagnostic and treatment decisions," he said.

The Alere i platform has a list price of $8,500, and each test cartridge costs $80, although actual prices negotiated with users are often lower, Stauffer noted.

Populating the platform

Alere will also continue development of more tests to populate the Alere i platform. A group A streptococcus test is "in front of the FDA currently," Stauffer said. The firm expects 510(k) clearance in the first quarter of this year. It will then resubmit for CLIA waiver, and expects that process to take six months.

Other tests on the agenda for the platform include one for respiratory syncytial virus ― which should be going into clinical trials shortly, Stauffer said ― as well as a test for Clostridium difficile, and one for gonorrhea and chlamydia. These tests are on a timeline to launch throughout 2015 and 2016.

The molecular CT/GC test is particularly interesting because a rapid test might break the cycle of infection and improve public health, as John Papp, a microbiologist in the US Center for Disease Control and Prevention's division of STD prevention noted. "If you can disrupt the transmission cycle quicker, that would be amazing; if you go into a doctor's office [and] get a result, and proper medication, before you leave ... that would be a remarkable shift," he said.

In the case of gonorrhea, anti-bacterial resistant strains may also become the next "superbug," and there is some discussion in the scientific literature that unless molecular tests simultaneously detect resistance markers, this might be imminent.

That said, the use of the Alere i flu test may promote better antimicrobial stewardship, Stauffer suggested, because physicians will know for certain there is no need for antibiotics. Antiviral drugs are recommended by the CDC, and, if administered within the first 48 hours of flu infection, can reduce severity and duration of infection. Increasingly antiviral-resistant flu is a possibility, and a sensitive and specific test could also help prevent this development.

At 15 minutes, the Alere i influenza test is by far the most rapid molecular option. The next fastest molecular test currently commercially available is the Cepheid Flu Xpert, which is CLIA waived for moderate complexity labs, and was recently cleared to be marketed in the US and validated in an emergency room setting.

A head-to-head of these two tests published last month in the Journal of Clinical Microbiology assayed 291 previously-analyzed frozen nasopharyngeal specimens from two prior flu seasons. "In comparing both molecular diagnostics, the Alere i system requires less technician time, minimal capital equipment outlay, and allows greater flexibility for personnel performing the assay in a point-of-care environment," the authors concluded. They also noted that the assay provided "rapid results in less than 15 minutes with two minutes of hands on time and a high sensitivity for detection of influenza."

Of note, with its acquisition of Iquum, Roche also acquired an influenza test that is already 510(k) cleared and can potentially be used at the point of care.

Stauffer pointed out that while test comparisons make a difference to end users in the lateral flow business, "when you step up to molecular, most clinicians understand that when they're getting a molecular result, the results [from] Cepheid versus an Alere i versus something else are not going to be all that different."

Future clinical studies will therefore emphasize how a rapid turnaround time helps physicians treat patients more efficiently, he said, adding that there is one study ready to start and another in preliminary stages. "These studies really required that we had CLIA waiver," he explained.

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