It almost seems that a new era of alternative test strips and other "basic" diabetes products has hit. It's a communicative of the multiplication, really, as big-name brands are hurting because of Medicare competitive bidding changes that are limiting access to pricier products pro of more economical options — giving producers of generics a fresh entry point into the market.

End week, a company called UniStrip Technologies announced availableness of a new FDA-approved taxonomic category exam strip, and concurrently, we got tidings that the green-coloured GenStrip mutually exclusive test despoil we reported on in recently 2012 is ramping up marketing later on some courtroom successes against Johnson and Johnson's family of LifeScan and OneTouch glucose meters (yes, they were being sued for patent infringement).

Along top of that, we noninheritable that the company behind the GenStrip is now developing its own recently all-inclusive wireless glucose meter that has strips, a lancet arch and smartphone app connectivity whol weaved into one device, called the Prudence.

These simplified products offer affordability, but perhaps a trade-off in terms of quality of care…  We looked into every last three to bring you the scoop.

Note that these two hot brands of generic strips work with some of the best-merchandising meter models made by LifeScan:

Inquisitive the New UniStrip

In early April, a new UniStrip taxonomic group made its mode to the U.S. market after snagging FDA favorable reception in November.

You can buy a 50-count out box of these strips for around $12 along eBay and Amazon right now (something I'm personally hesitant to do, because it seems shady to me) and in the sexual climax months we're told these strips will start coming into court on pharmacy shelves and smooth in big-key out retail stores, where we're told they'll sell for someplace around $9-10.

Developed by new formed North Carolina-settled UniStrip Technologies, they work with the LifeScan OneTouch Ultra family of meters — but ONLY those made and/or purchased before Oct. 2012, according to the FDA approval statement for this generic funnies.

CEO Wrick Admani is the man behind UniStrip Technologies. He also happens to be the chief operative officer of Omen Diabetes Care that makes the talking glucose meter for the vision impaired and other "off-brand" glucose meters. Admani tells us the two companies are legally furcate entities and not related, despite his executive role at some, and the fact that they are located within evenhanded 7 miles of each other in North Carolina, share the same general guidance and FDA consultant WHO applied for restrictive commendation of products, and they some apply the identical marketing agent.

Oh, and the fact that both outsource manufacturing to Taiwan-based OK BioTech — a manufacturer that purchased a minority stake in Prodigy a class ago.

Why does whatsoever of that substance? Well, patient advocates like those behind StripSafely meter accuracy campaign and others in the Diabetes Residential district have been quite vocal with criticisms of Prodigy products due to some struggles with the FDA ended the past year or then, most recently with the FDA calling out a Prognostic cadence Eastern Samoa being less accurate than others happening the market and attaching unique and never-before-seen labeling requirements to a mathematical product favorable reception.

So, if this same company putt out questionable quality is now qualification generic strips, that's something we consumers call for to be aware of — even if the concerns throw been addressed and signed off on aside regulators, which Prodigy says they have. You be the judge. But honestly to us, customer trust has been compromised here…

Despite that contention, Admani insists that UniStrip generics are as accurate if not more accurate than up brand-name products. He says UniStrips meet some the active FDA rules and also the 2013-enacted ISO guidelines. His company is also engaged in regular conversation with LifeScan, he says, and even revised its generic strip publicity some to appease the big manufacturer and ward unsatisfactory some potential litigation.

Admani tells us they're also developing at least three much UniStrip generics to work with other meters, on the far side just the J&J brands.

"We'ray the new player, and so naturally we'rhenium the ones that the gigantic manufacturers are loss to raise questions most," he said. "But this is a new change in this diabetes world, and it feels like we'Re going to see more new generic strips. It's going to alter the game."

Of course, this isn't the first alternative test strip to make headlines…

GenStrips Update

We reported before on the Los Angeles biotech society called PharmaTech Solutions that was planning an choice slip that would also do work exclusively with older OneTouch Ultra style meters, created before July 2010: the Shasta GenStrip.

Information technology got FDA clearance in November 2012, but the brakes were applied on getting those to patients when J&adenosine monophosphate;J sued its parent company Decision Diagnostics claiming unmistakable violatio.

That judicial proceeding is tranquil ongoing and PharmaTech lost at the lowest federal court level, but as information technology turns out the past year has been generally prescribed for PharmaTech — the biggest boost being that an appeals court panel overturned an injunction that had prevented the GenStrip from actually existence sold-out.

Main Financial Officer Keith Berman tells us that the recent Medicare competitive-bidding changes have caused PharmaTech Solutions to revise its business model; instead of selling now to patients, the company is now targeting local pharmacies. Indeed, GenStrips can now live institute on smaller pharmacy shelves and online at Amazon and eBay for around $15-18.

"The direct-to-consumer post order market place has pretty much died, and we're surprised away that. Both companies have even disappeared, and information technology's gone to brick-and-mortar pharmacies where patients blend in to salary co-pays and learn their strips," he same. "Pharmacies are under foreshorten, and Medicare bills the patient directly. So, that's presented a huge opportunity for USA."

Just this week, parent company Determination Diagnostics announced that it had acquired the GenStrip and all its trademarking rights from the original society, Shasta Technologies, following a new advertisement that started spreading concluding month in select parts of the area (and they say another newfangled one should be debuting before retentive):

So, information technology looks like GenStrip is hitting the market at full speed…. but is it keeping tread with on-going concerns about accuracy inside the regulative world and patient community?

Talk Test Strip Accuracy

This matter has gained a great deal of steam clean in the past year, with the unfinished FDA draft guidelines on truth still open for public commentary until May 7, 2014. In those guidelines, the FDA has specific language addressing character measures ordinal-party strip makers and that's something we, as a D-Community, should be supporting.

When asked about truth, some UniStrip and GenStrip developers cite plumping marque manufacturer recalls and say they expect no of those. And they quickly understate any concerns about quality, insistence that their products assemble current accuracy rules, just at more affordable prices.

Published information on the new UniStrip shows those taxonomic category strips arrange fall inside the existing and proposed rules just like most of the afoot competing products from man-sized-name manufacturers.

Simply we didn't get the same "pro-accuracy vibration" when it comes to GenStrip. CFO Berman tells us that GenStrips ut meet the existing FDA standard of falling within 20% of accuracy benchmarks most of the time, but helium said the strips fall just short of the 2013 ISO standard and the new draft FDA rules. Yes, GenStrip information shows that 93% of the time the GenStrips are within +/- 15%, but the Food and Drug Administration's swig rules call for 99% be inside that range when glucose levels are 75 milligram/dL or above. Til now reported to Berman, the company's non concerned with beefing heavenward accuracy to meet those standards, if IT's not required to do so.

"GenStrip is already cleared (by Food and Drug Administration)," Berman told America. "We do not have to make GenStrip comply to the new direction — which is only for new filings, not previously absolved filings."

Uh, huh. Well, good to know that GenStrips will meet the minimum requirement leastways. And regarding quality assurance, Berman did mention that patc FDA's existing guidelines call for a 95% achiever rate for new lots of strips to atomic number 4 discharged, GenStrip actually shoots for 97% each time.

Not amazingly, neither companionship had often to say about the notion of situatio-market surveillance (checks to constitute sure active products remain accurate), that patients have also been pushing for with the StripSafely campaign.

Altogether-In-Unrivaled Gl ucose Meter in the Works

PharmaTech is going beyond the GenStrip and actually developing a new all-inclusive combo meter with the ability to transmit psychometric test results wirelessly and securely to any cell phone gimmick that supports text electronic messaging, Berman tells the States.

Named the Discretion (maladroit constitute?), it would not use the GenStrips since those designed specifically for OneTouch Ultra meters. So another set of patented strips would be necessity.

The meter itself almost looks corresponding an old-school Walkman cassette player from the 80s and 90s, yet Berman tells us the size is "small plenty to equip into an 11-year-old's hand." It would rich person a lancet device built in and a expendable cartridge of test strips exclusive, all soul-contained.

This Circumspection meter's actually organism developed with kids older than 10 in mind, but Berman says it could also be a big seller for PWDs who travel much or who don't deficiency to sway a full test kit around everywhere. The data could exist sent past text message to adequate to 5 smartphones automatically and a loos app would allow you to consider that D-data.

The vision is to take this product showcased in big-name retail stores where it could equal even equal displayed at check out aisles, selling for $29.95 and you could bribe replacement strips in an 8-10 pack for $4.95, Berman tells us, adding that nonsubjective studies are likely to start in May, and they expect to file with FDA forthwith in one case those studies are complete.

We've seen too many "all-in-one" devices that have faltered to get precise excited about the Free will, but it is always exciting to examine innovation coming from completely corners of the market.

And when it comes to generics, in that location are always reservations about quality and accuracy.  We have seen the manufacturing facilities of many outsize Pharmaceutical company companies up close and personal and had in-depth conversations that exemplify the justification for high tryout strip costs (i.e. the enzymes, precious metals, chemicals, and other materials that make up the strips, plus the burden of building and maintaining manufacturing plants).  And scorn recalls that crop up periodically, we have to admit that it's comforting from time to tim knowing there's some credibility in the manufacturing process behindhand the products we're purchasing.

That said, atomic number 3 long American Samoa these new generic strips and off-brand meters are meeting accuracy requirements and providing quality that meets persevering needs, then there's no reason we can't also be excited or so these new, lower-cost options.

** UPDATE #1 – April 29, 2014: The U.S. FDA issued a safety admonition about the GenStrips, saying they may produce inaccurate readings and shouldn't be put-upon. A recent FDA review of the manufacturing deftness found "extensive violations" and found that many of the requirements for a superior system weren't in situ. To date, the keep company's been disinclined to voluntarily recall their test strips and sol the Food and Drug Administration advices everyone to stop using these taxonomic group strips.

** UPDATE #2 – April 30, 2014: In a response to the FDA warning, Decision Diagnostics and its subsidiary PharmaTech Solutions that acquired the GenStrip in mid-March says IT will replace all of the older GenStrips produced away the late owner, Shasta Technologies. They've also rebranded the strip American Samoa PharmaTech GenStrip 50.