Is There Finally Some Value Headed Guided Therapeutics Inc (OTCBB:GTHP)'s Way?

Here at Insider Financial, we're all about objectivity. Yes, we like to uncover under the radar stocks, because that's where the money is made. If we think a company is worth avoiding, however, we'll let you know and we'll let you know why.One that we have been watching for a long time, and a name some reading might remember (likely not for the right reasons) is Guided Therapeutics Inc (OTCBB:GTHP). The diagnostics focus biotech has basically collapsed to nothing over the last half decade. Having traded back in late 2011 for a little over $1.52 a share, guided now goes for $0.0009.It lost 10% yesterday alone.Over the last couple of months, however, volume has been picking up, and while price hasn’t really moved, millions of shares are trading hands daily. Volume hit 21 million on September 30. A few days earlier, September 26, it reached 19 million. And these aren’t anomalies.So what’s going on?The company just held a shareholder meeting that voted in favor of a 1:800 reverse split. This is going to tighten the float up considerably, and will probably make Guided a volatile hold over the coming few quarters. We think the split is a precursor to a wider plan, however, one that will (if it works) see it regain some credibility in the space.Earlier this year, the company's CEO, Gene Cartwright, put out a letter describing what the coming-to-fruition of what amounts to a total pivot in strategy. Investors can be forgiven for missing the pivot – it was clouded in a bunch of pretty much meaningless fluff – but it was there. This pivot is as follows:

"In late 2014, we began a refocus of the LuViva Advanced Cervical Scan from a niche gynecology product designed for triage in the U.S. and European Women’s Healthcare market to one that would address the problem of cervical cancer worldwide."

For those not familiar with Guided, it's got one product, the above mentioned LuViva, a cervical cancer test that uses light and gives a far quicker response than current SOC (Pap), and it sells this test and a disposable attachment designed for single use, per patient, per test.Currently, the product is approved in Europe, Canada and a bunch of Asian countries. Before the shift, however, the company was targeting the triage market.What does this mean? Triage is a method of separating positive readings with the goal of prioritizing serious patients. The normal process is test, diagnose, treat. Triage fits in between test and diagnosis. This means it only applies to positive initial screens, limiting Guided's potential market by a factor of six in the US, and more globally.With the pivot, the company is now targeting first line screening – primarily in regions that don’t have the necessary infrastructure to conduct efficient lab testing (as current SOC requires) and who, in turn, benefit from a single use, almost instant readout, closed loop system.So why is this important now?For the past half decade, markets have valued Guided based on its chances of US approval. The company has gone back and forth with the agency, but never really made any headway, and investors lost faith.Now, it's targeting first line in Europe and Asia, and we are seeing some progress in these markets. Russia, China, Bulgaria, Various African nations, Canada and Indonesia, among others, are using the test as a first line (not a triage) diagnostic. This is bread and butter revenue for the company, while it continues to go after the US market with an FDA approval. And there's been a key change here, as well.The FDA's decision to turn the tool down back in 2012 was rooted in the lack of data relating to how the test impacts triage data produced by HPV tests and biopsies. With the first line target indication now, this data isn’t really relevant, meaning the path should simplify somewhat. Guided reported on a meeting with the agency at the end of last year, and the company has a pathway in place that it believes could serve up an approval in as soon as twelve to twenty-four months.It's certainly not going to be smooth sailing – that's not the point we are trying to get across here. Cash is practically non existent, and the company is going to have to raise not just to support any FDA application, but also to maintain sales growth in Asia and Europe. What's different now, however, is that management has a plan to create some value, and that we may see some upside if it can execute.Near term, dilution is inevitable, but as a very cheap speculative allocation, it's well worth a look.Subscribe below and we'll keep you updated as this story plays out.Disclosure: We have no position in GTHP and have not been compensated for this article.