Rosetta Genomics Ltd. (USA) (NASDAQ: ROSG) recently hit a milestone in the efforts to expand the geographic availability of its FISH tests. The New York’s state department of health (NYSDOH) this week issued conditional approval for FISH tests. With that, the tests can now be said to be available across all the 50 states although there remain some hurdles for ROSG to go through to secure full approval in New York.
Rosetta Genomics Ltd. (USA) (NASDAQ:ROSG)’s FISH tests are used to evaluate progression or remission of cancers. The tests are particularly designed for detecting rearrangement or amplification of DNA of hematologic cancers. The types of liquid cancers covered by the tests are lymphomas, leukemias and myelomas.
Blanketing the entire U.S.
The New York conditional approval brings ROSG closer to covering the entire U.S. with its innovative cancer tests. However, the state demands additional permits before it can fully clear FISH tests.
It is worth pointing out that ROSG’s FISH tests are already accredited by CAP and certified by CLIA. But New York has requested for an additional permit for each of the tests to clear the last approval hurdle to full approval. ROSG has 60 business days to furnish the New York’ states health department with the additional requested information.
A delightful development for Rosetta Genomics Ltd. (USA) (NASDAQ:ROSG)
According to Rosetta Genomics Ltd. (USA) (NASDAQ:ROSG)’s CEO, Kenneth A. Berlin, the New York’s approval for FISH tests has delighted the management. But the greatest beneficiary is expected to be the patients.
With the FISH tests, physicians can better determine the treatment options for patients, thus increasing the chances of cancer treatment success.
ROSG hopes to unlock more revenue as it takes its FISH tests to more geographic locations and expands its portfolio of quality tests.
Revenue up 711%
Rosetta Genomics Ltd. (USA) (NASDAQ: ROSG) said its revenue in 1Q2016 rose 711% YoY to $2.6 million with revenue from the sale of urologic cancer testing services jumping 7% YoY to $1.4 million. Revenue from the sale of solid tumor testing services was up 272% YoY to $1.2 million.
With that, ROSG’s bottom-line improved to EPS loss of $0.20 from EPS loss of $0.30 a year earlier.