ABOUT US
Behind every ID-FISH test is a passionate team of experts.
COMPANY HISTORY
Since 2004, ID-FISH has pioneered a number of assays for direct detection of infectious diseases in clinical samples. Two Malaria FISH assays kits, ID-FISH Plasmodium Genus Test Kit (PlasG) and ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit (PlasFV), were the first FISH assays approved by the FDA for clinical use in 2017.
Unfortunately, many of the countries with widespread malaria and TB infections rely on the World Health Organization (WHO) for approval to perform tests. The WHO was not set up to validate FISH testing, making it a challenge for ID-FISH to acquire the necessary licensing and approvals. Therefore, in 2015, the company changed its focus to development of immunoassay reagents for tick-borne diseases.
FROM MALARIA TO TICK-BORNE DISEASES
In 2015, the company spent hours talking with patients of tick-borne illnesses and listening to their stories. Many had compelling historical and clinical evidence of disease, but were testing negative on the commercially available tests. Physicians were equally frustrated because there were few good tests to be found, and their patients were seriously ill and not getting the proper treatment.
Soon after, ID-FISH started developing TBRF and Lyme multispecies ImmunoBlot strips. The company collaborated with IGeneX Laboratory to develop ImmunoBlot assays using the IB strips. This new diagnostic tool has greatly improved the ability of physicians to diagnose the disease. ImmunoBlots are available for Lyme disease, TBRF, Bartonellosis, and Babesiosis.
LEADERSHIP
ID-FISH has, and will continue to hire, the most qualified scientific and administrative staff to develop, manufacture, and market its tests. We have the following people on board.
Dr. Jyotsna Shah, PhD, MBA
Chief Scientific Officer
Dr. Shah is the Chief Scientific Officer of ID-FISH. She has over 20 years of experience in developing molecular and immunological diagnostic tests for infectious diseases. She is an expert at serology technology for infectious disease diagnostics. She is the principal investigator for the all test kits, and has over 12 patents awarded. In addition, she has extensive experience in managing a clinical diagnostic reference laboratory.
Iris Cruz, MBBS, CLS
Laboratory Consultant
Ms. Cruz is the Clinical Laboratory Manager of ID-FISH. She has extensive knowledge in operations, quality, compliance, sample collection and clinical studies. She is part of the team that validated Lyme disease and TBRF Borrelia ImmunoBlots. Her role in the two projects was to provide left-over blinded decoded patient sera for the studies on immunoblots for the detection of antibodies in patients with infections caused by RFB and LDB; and to oversee the validation study.
SBIR Grants
ID-FISH has been awarded numerous grants from the Small Business Innovation Research project. These grants enabled the company to patent its technology and develop FDA approved test kits.
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M. tuberculosis FISH Assay
Year: 2004
Grant #: SBIR Phase I - AI056785 -
P. falciparum and P. vivax Fluorescense In Situ Hybridization
Year: 2006
Grant #: SBIR Phase I - AI056785 -
TB-FISH Assay for Direct Detection of M. tuberculosis in unprocessed sputum
Year: 2007
Grant #: SBIR Phase I - AI075745 -
Plasmodium Genus and P. falciparum - P. vivax FISH Assays
Year: 2008
Grant #: SBIR Phase II - AI056785 -
Multiplex TB-M. avium complex FISH Assay, direct from sputum
Year: 2009
Grant #: SBIR Phase I - AI075793 -
TB FISH Assay for Direct Detection of M. tuberculosis in sputum
Year: 2009
Grant #: SBIR Phase II - AI075745 -
Plasmodium Genus and PlasFV FISH Assay Kit for direct detection of malaria in blood
Year: 2014
Grant #: SBIR Phase IIB - AI056785
INSIDE THE LAB
ID-FISH rents 3000 sq. ft. of space in a facility that meets CLIA and CDC guidelines for a high complexity testing laboratory with BL2 facilities. The lab has over 10,000 sq. ft. of space that includes the necessary utilities such as power, water, air-conditioning and a heating system. Everyone at the lab is trained in handling clinical samples properly. To prevent exposure to infectious agents, the following engineering controls are implemented: Biosafety cabinets, proper ventilation, and closed top centrifuge rotors. The following Personal Protective Equipment (PPE) is provided to protect personnel from exposure: gloves, lab coats, face shields, and masks.
The company owns an AKTA antigen purifier, computers, rockers for blocking and QC of strips, incubators for drying membranes, biosafety cabinets, scales, a liquid filling machine, cappers, a label printer, a batch/lot number printer, freezers/refrigerators (including -70 degree freezer), liquid nitrogen storage, sonicator, shaker incubator, and refrigerated hi-speed centrifuge, a strip backing laminator, strip slicer, and blot dispenser.
WHY CHOOSE ID-FISH?
- Long track record of success since 2004
- Owns multiple FDA approved products
- Has secured patents on FISH and ImmunoBlots
- Has won numerous SBIR grants
- Offers testing that is nearly twice as accurate as CDC recommended tests
Get in Touch
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