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Radient Pharmaceuticals: speculation intensifies over commercial potential of Onko-Sure cancer diagnostic test

The test developed by Radient is substantially different from those marketed by other companies: it detects breakdown products of the proteins Fibrin and Fibrinogen, which are produced by cancer cells
Radient Pharmaceuticals: speculation intensifies over commercial potential of Onko-Sure cancer diagnostic test

The major operation of Radient Pharmaceuticals (Radient)(AMEX:RPC) is the marketing and development of its cancer diagnostic test, Onko-Sure. This simple and relatively inexpensive test kit has been clinically shown to accurately identify multiple cancers at the earliest stages, allowing for early therapy and potentially improved patient outcomes. If this bears out, billions of dollars could be shaved from the US health care system alone.

Radient began marketing its novel cancer detection kit approximately two years ago. Sales have been slow to take off as the company lay the ground work for its international roll out. It now has distribution arrangements in India, South Korea, Latin America, North America, and the Asia Pacific region.

The test developed by Radient is substantially different from those marketed by other companies. It detects breakdown products of the proteins Fibrin and Fibrinogen, which are produced by cancer cells; levels of these breakdown products act as a “barometer for cancer”. This test is easy enough to be performed by individual labs. By contrast, many other diagnostics in development look at sets of genes to determine a patient’s predisposition to certain cancers or likelihood to benefit from specific treatments. These tests may cost thousands of dollars, precluding widespread use as screening tools.

Onko-Sure’s slow start notwithstanding, Radient’s management has big expectations for its product. It is targeting four key markets:

1.    Colorectal Cancer (CRC) monitoring in the US and Canada
2.    Colorectal Cancer monitoring in international markets
3.    Government backed general cancer screening
4.    Lung Cancer screening and monitoring in Canada

The company estimates CRC monitoring represents a $450 million market and has FDA approval for this indication. According to the company, Onko-Sure has been shown to be superior to the current CRC monitoring test, Carcinoembryonic Antigen (CEA), able to identify cancers at an earlier stage.

But by far the greatest opportunity for Radient is the use of its kit in government backed cancer screening, estimated by the company to be a possible $1 billion market. This use has not been approved by the FDA therefore sales are predominantly outside the US.

The largest market for Onko-Sure for now is India due to the government’s backing of a general cancer screening initiative. Estimates for 2011 project 25,000 kits sold in India and 36,500 kits sold overall. The company’s own estimate is a slightly higher 38,500; if this target is met, Radient has the potential to generate up to $15.4 million in 2011 revenue with $8 million in net income based on a $400 per kit selling price.

While the current FDA approval is CRC monitoring, it is obvious the company is seeking to position Onko-Sure as a cancer screening tool. It has estimated that in order to reach $1 billion in sales from government backed cancer screening, annual kit sales will need to reach 1,488,095 units annually. Interestingly, this number also implies the sales price per kit will rise from $400.

Radient has also begun rolling out a lung cancer screening kit called LC Sentinal in the US with partner, Provista Diagnostics. This kit was co-developed by the two companies and is based on the same technology as Onko-Sure. Provista intends to market the kit initially as a laboratory developed test, in which case, each individual laboratory using the kit will need to validate the test prior to its use. The companies will seek FDA approval for the kit in 2011; once this happens, kits can be marketed much more broadly without the need for validations from individual labs.

It should be noted that Radient is in the process of purchasing Provista Diagnostics, though the terms have not been finalized. The merger will provide Radient with full control of the LC Sentinal test along additional breast cancer and woman’s reproductive cancer tests. This is a natural fit considering the strong ties and synergies between the two companies.

Outside its core cancer diagnostics focus, Radient also has stakes in a couple other entities through legacy operations. The company once owned Jade Pharmaceuticals Inc (JPI) of China, a manufacturer and distributor of generic and homeopathic pharmaceutical products, nutritional supplements and cosmetics. It also owned intellectual property to Combination Immunogene Therapy (CIT), a vaccine for non-small cell lung cancer  (NSCLC).

In late 2009, Radient sought to “monetize” these two assets as it repositioned itself as a pure-play diagnostic company. This goal is approaching fruition as JPI is set to acquire fellow Chinese pharmaceutical company, Shanxi BaoTai. Once merged, the company intends to list on the NYSE AMEX exchange.

A partner has also been found to further the development of the CIT vaccine technology. In December 2010, a new subsidiary, NuVax Therapeutics was formed in collaboration with biotechnology company, Jaiva Technologies to develop the technology as well as additional immunotherapies. 

Now that Radient has found new homes for its non-core assets, it can fully focus on implementation of its Onko-Sure roll out.

More recently, the company has announced  a debt-for-equity swap which will eliminate its $31 million of debt and liabilities, significantly improving its balance sheet. BioMedReports also recently reported that investors in the company are “keeping an eye out” for preliminary results from a validation study assessing Radient’s Onko-Sure test in detecting early stage colorectal cancer. 

Radient recently put out a press release stating that it does not to comment on unusual market activity or rumors, in response to significantly higher than average trading volumes in the company’s stock.

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