A new player has entered the molecular diagnostics field, a field that has been seeing, as of late, strong developmental activity and regulatory okay.

Following on the heels of other companies, Health Discovery Corporation (HDC; Savannah, Georgia) reported that it now has a new gene-based test, this one for prostate cancer, that has successfully completed a Phase III double-blind clinical trial.

Results from Phase I, Phase II and Phase III double-blind clinical validation studies now completed with prostate tissues obtained from multiple sites – including those tested in collaboration with MD Anderson Cancer Center (Houston) – demonstrated a high success rate for identifying the presence of Grade 3 or higher prostate cancer cells (clinically significant cancer), as well as normal and benign prostatic hyperplasia (BPH) cells.

To date, 322 prostate tissues have been tested, according to the company. And the combined results of the recently completed double-blinded clinical validation studies demonstrated that the gene-based test achieved a sensitivity of 90% for correctly identifying the presence of Grade 3 or higher prostate cancer cells, and a specificity of 97% for correctly identifying non-cancer cells (normal and BPH), representing an overall test accuracy of 93%.

"We ... are excited to have our first revenue-producing molecular diagnostic test ready for commercialization," said Stephen Barnhill, MD, CEO and chairman of HDC. "The successful development, validation and commercialization of this new molecular diagnostic test for prostate cancer proves that HDC, by combining our patented SVM and SVM-RFE technology and our expert Scientific Team, has the ability to produce new molecular diagnostic and prognostic tests which are the future of personalized medicine."

He added: "Our patent-protected discovery method allows us to develop molecular diagnostic and prognostic tests that are free of outside intellectual property rights and thereby allows HDC to fully patent protect our molecular diagnostic gene signatures. Using the same expertise of our Scientific Team and the HDC patented technology, we are currently developing additional new molecular diagnostic tests in a variety of other cancers some of which we hope will be commercially available in Q4 of 2008."

The new test will be performed at Clarient's Clinical Laboratory (Aliso Viejo, California), with HDC receiving a 30% royalty on each test performed.

In the U.S., there are more 1 million prostate cancer tissue biopsy procedures performed annually, nearly 25% of these reported "positive," indicating the presence of prostate cancer.

However, one-third of the men in the 75% of those with initial prostate cancer tissue biopsies reported as "negative" for prostate cancer (roughly 25% of men at risk of having prostate cancer) actually do have prostate cancer that was missed by the first biopsy (a false negative) – missed by the initial tissue biopsy for a variety of reasons.

HDC said its genomics-based test should be performed on the 75% of men (about 600,000 men annually in the U.S.) with initial biopsies reported as negative to assist physicians in identifying those men who could have prostate cancer that was missed by the first biopsy.

The company is entering a gen-based diagnostics arena becoming increasingly crowded.

Last year FDA cleared Agendia's (Amsterdam, the Netherlands) MammaPrint, a molecular diagnostic tool developed to predict whether existing cancer will spread to other parts of a body (Medical Device Daily, Feb. 7 2007).

Just last week the FDA cleared a test developed by Pathwork Diagnostics (Sunnyvale, California) that would help to determine what specific type of cancer cells are present in a malignant tumor (MDD, Aug. 4, 2008).

There is also the OncotypeDX test by Genomic Health (Redwood City, California) which determines the likelihood of breast cancer recurrence in women with newly diagnosed, early-stage invasive breast cancer as well to assess whether the patient will benefit from chemotherapy.

These tests are already changing how physicians are treating breast disease and have the potential to significantly alter a patient's treatment plan. Traditionally, tumor characteristics such as size, lymph node involvement, have determined whether a patient receives chemotherapy. Studies now verify that cancer thumb-printing provides greater insight into the disease and test results should supersede the less-sophisticated measures used to assess the benefits of chemotherapy in the past.

HDC said it plans to begin presenting papers for publication and presentations at upcoming meetings as it initiates marketing.

Because of the clinical trial success of this prostate cancer test, the company said it plans to initiate a study using urine samples to expand the indication of its new prostate cancer test.

Its efforts in this area may be reduced, however, by the recent recommendation from the U.S. Preventive Services Task Force against the diagnosis of prostate cancer in men age 75 and older (Medical Device Daily, Aug. 7, 2008).

The task force emphasized the slow growth of prostate and said that aggressive therapy based on a positive biopsy, and the biopsy itself, may result in shortening the life of those in this age group more quickly than the disease itself.

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