Immune-Trace (TM): Next Generation Drug Testing

Immune-Trace

Boston based company, Lucid Biostatistical Consulting LLC., d.b.a. “Immune-Trace” is a medical device manufacturer (kit assembler) with FDA-exempt next generation of drug testing kits for employment or insurance testing.

• Top 5 major drug of abuse classes can be tested for employment and/or insurance purposes using Immune-Trace ELISA reagent kits, including:

Opiates

Cannabinoid (marijuana)

Amphetamine

Barbiturate

Cocaine

Table 1. Comparison of drug of abuse detection window across test methods

TARGET DRUG	Urine	Saliva	Blood (Current)	Immune-Trace
BARBITUATES*	1 – 4 days	12 – 24 hrs	1-2 days	4 – 6 Months
COCAINE*	1 – 5 days	8 – 18 hrs	1-2 days	4 – 6 Months
OPIATES*	1 – 4 days	12 – 24 hrs	1-2 days	4 – 6 Months
AMPHETAMINE*	1 – 4 days	12 – 24 hrs	1-2 days	4 – 6 Months
MARIJUANA*	1 – 30 days	5 – 14 hrs	1-2 days	4 – 6 Months
Method of Detection	LIFA/ELISA of Metabolites	LIFA of Metabolites	Metabolite detection	ELISA of Antibodies

• * FDA exempt when testing for employment and/or insurance purposes

• U.S. Patent issued in 2013 with broad protection, expires in 2032.
• Large market (insurance and employment testing) with significant opportunity to improve testing paradigm
• Immune-Trace specificity is better than that of commonly used field drug testing methods, whereas sensitivity is dramatically better (~90% vs ~50%). At present an estimated 50% of drug abusers pass the drug tests that employers administer. Source: http://www.medpagetoday.com/MeetingCoverage/APA/20253
• Current tests for drugs of abuses typically look at the presence of drug-specific metabolites in the urine, that last for at most two to three weeks after last exposure to the drug.
• This novel tool detects drug-specific antibodies that the immune system generates in response to repetitive (three episodes or more) of drug intake, and persist to circulate in the bloodstream for up to 5 months after last exposure.
• Currently the method is a 96-well ELISA format and can be used with automated ELISA processing machines for high-throughput screening (ex.: Stratec Biomedical AG “Gemini” machine).

• Immune-Trace Technology Mechanism of Action:

• Antibodies are raised against natural conjugated antigens after 3 times of DOA (drug of abuse) usage.
• Longer usage endurance, more frequent usage, higher dosage – the higher Antibodies to DOA (drug of abuse) level.
• The organism stops producing and circulating (in bloodstream), the Antibodies to DOA (drug of abuse) after 4-6 months after last episode of drug intake.

•Advantages of Immune-Trace for Insurance:

–Detects significantly more drug abusers (95% sensitivity, and 4-6 months track-back window) than urine tests (50% sensitivity) or other blood tests (~2 days track-back window)

–Enables insurance companies not to issue policies to drug addicts.

–Median expected life span of drug addict is 7 years, so filtering them out from life insurance is crucial.

–Large track back window of 4-6 months, substantially longer than competition.

–Enables detection of starting addicts and moderate level abusers as it detects when person has used drug for at least 3 times in last 4-6 months.

Contact:    Arkady Gershteyn – CEO  & Founder |  ArkadyGer@gmail.com | (617) 797‐1800