If you have a nodule on your thyroid gland, you are in good company. About five percent of the population has such bumps, 90 percent of which are harmless.

But as more doctors do “neck checks” they’re finding more of these nodules, and each finding must be examined to rule out cancer. That adds up to more than 550,000 fine-needle aspiration thyroid biopsies every year in the United States alone. About 15% to 30% of the biopsies result in an indeterminate diagnosis, and in these cases the doctor must perform a second invasive biopsy or completely remove the thyroid to be on the safe side.

Now there is a better alternative to these repeat biopsies and possibly unnecessary thyroid removal: RosettaGX Reveal, a microRNA-based diagnostic assay to reevaluate indeterminate thyroid nodules using the sample collected during the original biopsy. The results are highly accurate, whether malignant or benign.

“Our goal was to develop a test that would help eliminate some of these unnecessary surgeries,” says Rosetta Genomics executive vice president of sales and marketing Doug Site. “Every other test out there requires the doctor to get additional samples from patients when there is an indeterminate diagnosis.”

Rosetta Genomics’ R&D is based in Rehovot, Israel. The company has US headquarters in Pennsylvania and California.

“Our R&D in Israel has been amazing in figuring out that by using the very stable microRNAs, we could make a diagnosis using the smear from the original biopsy,” Sites tells ISRAEL21c. “The patient knows within seven to 10 days if the nodule is cancerous or not.”

Sophisticated R&D

Launched commercially at the International Thyroid Congress in Florida last October, RosettaGX Reveal is the only test of its kind that does not require a new sampling of the nodule.

A nurse or physician assistant can put the slide in a provided pouch – no kits or cold packs required – and send it to a local cytopathology lab or to Rosetta’s lab in Philadelphia or Lake Forest, California.

“We have already seen a number of cases come in from around the country,” says Sites. “We had a couple that went first to a competitive molecular test and came back as ‘quantity of cells not sufficient,’ so the doctors sent us the slides and in both cases we were able to say it was benign. The patients may be able to live with those nodules the rest of their life. This is because our R&D is so sophisticated and we’re able to make calls competitors can’t.”

Sites noted that Rosetta’s main competitor for assessing indeterminate thyroid biopsies requires two additional fine-needle procedures and in many cases diagnoses benign cases as suspicious for malignancy. This competitor also requires evaluation by its own cytopathologists.

“Giving doctors the option of using a local group to make the evaluation with our assay allows them to continue their relationship with their local pathologists. If the local lab does not have experts in thyroid cancer, we also offer the option of sending the slide to our experts. No other company offers that,” says Sites.

The cost of the assay is comparable to that of competitors, and normally is covered by health insurance.

High cure rate

The American Cancer Society estimated that there were about 62,450 new cases of thyroid cancer in the United States in 2015.

“Thyroid cancer is relatively curable if you remove the thyroid,” says Sites.“The old adage was ‘When in doubt take it out,’ so five years ago if you had an indeterminate diagnosis they’d remove that part of the gland and the pathologist would look at it immediately or later, and possibly there would be a second surgery.”

Hormones released from the butterfly-shaped thyroid gland affect and control nearly every cell in the body. People without a thyroid gland must take synthetic hormones daily.

In the coming months, Rosetta Genomics will publish results of its latest study on the performance of Reveal. Use of the test could prevent more than 70% of unnecessary thyroid surgeries, according to the findings.

“As we continue to analyze and parse the data from our multi-center, blinded validation study for RosettaGX Reveal, our confidence grows in its exceptional performance and in our belief that it will be a very competitive assay,” said Rosetta Genomics President and Chief Executive Officer Kenneth A. Berlin.

Reveal is the newest product in Rosetta’s series of microRNA-based diagnostic testing services. The existing line includes RosettaGX products to identify primary tumor types and to identify and/or classify subtypes of lung, kidney, breast, prostate and bladder cancer using small amounts of tumor cells.

The company, which is publicly traded on NASDAQ, estimates that RosettaGX Reveal will be used for 150,000 patients a year in the United States and around the world.

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