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Have I had too much to drink and drive – A Solid Solution to Answer the Big Question… What if you had the power find out quickly what your blood alcohol level is, would you be interested? You could be saving one life or more in the process. This is what we are here to talk about, an amazing new product that can do just that in the matter of two short minutes of your time you can find out if it is safe to be within the legal limits of the law with your blood alcohol content, and that the guessing game right out of the question. Introducing “LifeSaver” Stiks Æ that give you the freedom and allow for intelligent lifestyle decisions. How many times have you had a drink or two or more and wondered what your body alcohol content was and if you are “safe” to drive? This is just one test accomplished with the non invasive technologies that LifeSaver has to offer! “LifeSaver” opens the door to that question we may all ask ourselves from time to time when we consume alcohol. Why guess when you can get an answer and remove the risk of bad judgment calls, as alcohol can give a sense of false confidence which after drinking, especially if you want to drive is not a good thing. 99.9% accuracy is also in your hands when using our product. It doesn’t get much better than that ! Just think for checking alcohol levels in your body, it’s not necessary for a doctor to be present, much less a law enforcement official and nobody relishes that experience. Instead of putting yourself and others in jeopardy when getting behind the wheel and driving, why not “test yourself” first. You really can’t lose as a very small amount of saliva is required for the test to complete and the Stiks Æ even “test themselves” to ensure there has been no tampering with the testing unit. If the product does not show a result of either positive or negative, then toss it and use another one and so no worry about “false positives” as that is always a concern with any type of lab testing today. The image on the left shows how the easy the results are to read, just look for the plus or negative response to read the results. The product has no special environmental needs, so if stored in a place where the temperature reaches 100 degrees – no problem as the product can hold up to the demands of surviving in most any environment. When testing for alcohol, a minus sign means you are under the legal limits of 0.08% and if you see the plus sign, that means don’t drive and that your blood content is over the legal limit and you can made an intelligent decision to have someone else drive, wait a while or call a cab. The shelf life is 2 years so if you put one in your purse today, it’s good to go in a couple months or even longer. In the workplace, restaurants, etc. Stiks Æ offer timesaving solutions and ease of use. Just think if you were applying for a job and had to have a screening for alcohol or drugs, no running to the rest room or a laboratory facility and chances of compromising as the test is quickly done in view of all. In the fast paced world we live in today, time is so valuable and having accurate information in hand is more than valuable, it can be a “Lifesaver” . Find out today what LifeSavers can do for you in less than 2 minutes time. Follow us on our website and talk with us on Twitter and Facebook. We would love to hear what you have to say and we will keep you updated on all our new products and services as they become available!

LifeSaver Information Documents

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LifeSaver Stik for HIV, alcohol and drug testing, 2 second swipe with 2 minute results and may change the diagnostic and screening world forever.

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Page 1: LifeSaver Information Documents

Have I had too much to drink and drive – ASolid Solution to Answer the Big Question…

What if you had the power find out quickly what yourblood alcohol level is, would you be interested? You couldbe saving one life or more in the process. This is what weare here to talk about, an amazing new product that cando just that in the matter of two short minutes of your time you can find out if it is safe to be within thelegal limits of the law with your blood alcohol content, and that the guessing game right out of thequestion.

Introducing “LifeSaver” StiksÆ that give you the freedom and allow for intelligent lifestyle decisions. Howmany times have you had a drink or two or more and wondered what your body alcohol content was andif you are “safe” to drive? This is just one test accomplished with the non invasive technologies thatLifeSaver has to offer! “LifeSaver” opens the door to that question we may all ask ourselves from timeto time when we consume alcohol. Why guess when you can get an answer and remove the risk of badjudgment calls, as alcohol can give a sense of false confidence which after drinking, especially if you wantto drive is not a good thing.

99.9% accuracy is also in your hands when using our product. It doesn’t get much better than that! Justthink for checking alcohol levels in your body, it’s not necessary for a doctor to bepresent, much less a law enforcement official and nobody relishes that experience.Instead of putting yourself and others in jeopardy when getting behind the wheel anddriving, why not “test yourself” first.

You really can’t lose as a very small amount of saliva is required for the test tocomplete and the StiksÆ even “test themselves” to ensure there has been notampering with the testing unit. If the product does not show a result of eitherpositive or negative, then toss it and use another one and so no worry about “falsepositives” as that is always a concern with any type of lab testing today. The image onthe left shows how the easy the results are to read, just look for the plus or negativeresponse to read the results. The product has no special environmental needs, so ifstored in a place where the temperature reaches 100 degrees – no problem as theproduct can hold up to the demands of surviving in most any environment.

When testing for alcohol, a minus sign means you are under the legal limits of 0.08%and if you see the plus sign, that means don’t drive and that your blood content is over the legal limit and youcan made an intelligent decision to have someone else drive, wait a while or call a cab. The shelf life is 2years so if you put one in your purse today, it’s good to go in a couple months or even longer.

In the workplace, restaurants, etc. StiksÆ offer timesaving solutions andease of use. Just think if you were applying for a job and had to have ascreening for alcohol or drugs, no running to the rest room or a laboratoryfacility and chances of compromising as the test is quickly done in view ofall. In the fast paced world we live in today, time is so valuable and havingaccurate information in hand is more than valuable, it can be a “Lifesaver”.

Find out today what LifeSavers can do for you in less than 2 minutes time. Follow us on our website andtalk with us on Twitter and Facebook. We would love to hear what you have to say and we will keep youupdated on all our new products and services as they become available!

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Healthcare Diagnostics Is Becoming Highly Disruptive – How to Be Part ofthe Investment Revolution and Help the World Get Healthier ThroughInnovative Technologies

Now that we have your attention please take a look at wherethe world of diagnostics and saliva testing is headed with apatented, simple and efficient way to save lives. Certainly you

may have heard some of this before, but you have not heard our story so please take a few moments ofyour time and see what is emerging with creating simple and efficient diagnostic processes and the abilityto save lives. If this is something that attracts your interest, and why wouldn’t it, please read on as theanswer lies in the StiksÆ.

So what are StiksÆ and what do they do? First of all they take acomplicated and time consuming diagnostic test and make itsimple, easy for the person giving the test and easy for the persontaking the diagnostic test. No doubt you are aware of all thetypes of screenings and lab tests that are on the market today andyes they are plentiful but each one has a “specific” process tofollow in order to ensure accuracy. What if those processes couldbe ideally simplified and the areas of false positives erased? Doesthis sound interesting…read on…

Our flagship product is called “LifeSaver” which is a simple and effective device, a stick that can be usedto detect levels of alcohol and drugs in the body. Currently as an example, an individual has to go to alab and have a blood or urine test to provide the desired results. We all know that there are accuracyrisks with many trying to beat the system with using a urine analysis process in either substituting asample that is not theirs for one example, and plus they have to leave the room and visit a restroom inorder to capture the sample. What if that process was no longer necessary? LifeSaver can do just thatand eliminate the need for a trip to the restroom and to the lab. Sound too good to be true, well it’snot.

The key to the LifeSaver process is not testing blood or urine, but rather using saliva to attain quickaccurate results. If you watch any of the CSI shows on television today you always see the investigatorsusing a “DNA swab” to collect their evidence, so why does healthcare make it so difficult. Should we nothave the same convenience for testing here as well? Again, we do with LifeSaver. The process is verysimple and answers are given in two minutes. Think of the industries that would benefit from the use ofsuch products when testing for alcohol and drug abuse? Another use would be in the area of humanresources with a pre-employment test. The money that companies spend is huge in this area and if anemployer could have answers on the spot without the lab and urinetests, would they be interested, you bet they would.

In addition for marketing and advertising campaigns, an area not tobe overlooked, think of the possibilities of being able to hand outprivate labeled products. It could be anywhere, at a baseball gamewith having a beer or liquor company sponsoring “safe driving night” asan example, have one available for free upon entering the stadium. Another scenario would be a privatelabeled product for a restaurant to hand out when the customer is done paying the bill after they have

Page 3: LifeSaver Information Documents

enjoyed a nice evening and consumed a bit of alcohol with dinner. This is a nice way for the restaurant toallow their patrons to check their blood alcohol level and make a responsible decision and the companywith the private label name on the devices will definitely be remembered.

Distributorships per state will be offered that are exclusive along with incentive perks with revenuesharing at a national account layer as it will encourage servicing of such and an entire circle ofdistribution without any distribution facilities as all orders will be drop shipped and a selection ofsample products is the only inventory to be maintained and as you can see the product is very small andrequires no special storage or temperature control. The wholesale cost for one stick doing 7 tests is $7.00 so where can you find lab tests at that price. Again the product can be specified to only test foralcohol as well and the wholesale prices of course would be less and all products will be made in the US towhere quality control is assured.

This is only the start as LifeSaver International Inc. in association withTtest, a medical device manufacturer of saliva based testing products,takes this same technology up to the next level with diagnosing diseasesand conditions that either kill people or create handicapped orundesirable lifestyles for all over the world if left untreated. LifeSaver andTtest have acquired 14 new patents as well as trademarks in the US andover 100 countries worldwide to create and manufacture the products.Laboratories that are FDA approved are currently identified and can producethe product with our supervision and patented processes right here in

southern California.

Industries that stand to benefit include law enforcement,transportation, common carriers, the military, insurancecompanies, hospitals, and last but not least the Red Cross. The possibilities are almostendless as with Ttest the company goes beyond the alcohol and drug level testing with theStiksÆ having medical device identification via the FDA, with a 510K Fast Track application as allentities contained in the patented areas of the products already have FDA approval.

This is the beginning of the process but what happens when the information is secured, howdo you keep track of what test belongs to whom? The LifeSaver StikReader® handles the nextstep. In the world of mHealth today this is the perfect solution as it uses proprietarysoftware to match with fingerprints, scanned IDs and more to make and store theconnection in an encrypted data base. Each record is time stamped and uses GPS to recordthe where the test information was entered.

So far we have just talked about the human side, but imagine farmers being able to test cattle andrather than the finger print from a cow, use the “ iris” capabilities and they would have an entire database on all the livestock they have tested.

Imagine the possibilities too with diabetes and being able to offer someone who is a diabetic, and whodoesn’t know someone who is diagnosed today with diabetes, of offering a way to test glucose levelswithout using blood and pricking their finger.

This in itself is huge offering and solution for those who every day go through the process of checkingtheir blood sugar a few times day.

Our marketing campaigns will include The World Health Organization (WHO), CHAI (Clinton HealthAssurance Initiative), and the Bill & Melinda Gates Foundation along with Fortune 500 companies as this no

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doubt will be a game changer in changing the world of diagnostics and creating better health word wide withsimplistic solutions that can be utilized anywhere. Does this sound like something you want to be a part of?

We have also included for a preview look at how the marketing will be presented for consumer awareness aswell. Consumer awareness and approval is very much a part of the solution and will be addressed and utilizedappropriately via social networking to create a positive and inviting perception.

Current manufacturing costs are $0.75 for single-pad products and $1.50 for multi-pad products and thewholesale prices will range from $1.50 to $7.00 and again all made in the USA. Revenue projections withadditional details are available to further substantiate the value of an investment in our products. Visit ourwebsite for more information and for detailed investment opportunities contact us at the phone number oremail listed below as this is an outstanding opportunity to invest at the ground level with technologies thatare set to both disrupt and improve healthcare and screening processes around the world and at the sametime provide a desired return on your investment.

www.aLifeSaver.com

Phone: 949-367-1191

[email protected]

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25108 Marguerite Parkway, Suite A260 • Mission Viejo, Ca. 92692 • Tel: (949) 367‐1191  | Fax: (949) 367‐1022 

 

LifeSaver and OraQuick HIV Product Comparison

FDA approves 1st rapid, take-home HIV test OraSure’s “OraQuick” Associated Press - July 3, 2012, 1:09 p.m.

The U.S. Food and Drug Administration has approved the first over-the-counter HIV test, allowing Americans to check themselves for the virus that causes AIDS in the privacy of their homes. The OraQuick test detects the presence of HIV in saliva collected using a mouth swab. The test is designed to return result within 20 to 40 minutes. Government officials estimate one-fifth, or about 240,000 people, of the 1.2 million HIV carriers in the U.S. are not aware they are infected. Testing is one of the chief means of slowing new infections. FDA officials said the test is aimed at people who might not otherwise get tested. "The availability of a home-use HIV test kit provides the option for individuals to get tested so that they can get medical care," said Dr. Karen Midthun, of the FDA's Center for Biologics Evaluation and Research. A trial conducted by Orasure showed the home test correctly detected HIV in those carrying the virus only 92 percent of the time. That means the test could miss 1 person for every 12 HIV-infected people who use the kit. The test was accurate 99 percent in ruling out HIV in patients not carrying the virus. That means the test would incorrectly identify one patient as having HIV for every 5,000 HIV-negative people tested. The FDA previously approved several HIV test kits designed to be used at home, although those kits - usually require a blood sample - must be sent to a laboratory to be developed. Orasure has marketed a version of OraQuick to doctors, nurses and other health care practitioners. When used by professionals, the test is shown to accurately identify both carriers and non-carriers 99 percent of the time. While it's not clear why the test appears less accurate in consumer trials, company researchers said they expected the test's specificity to drop when used by consumers versus professionals. Orasure plans to launch the test in October, selling it through retailers like Walgreens, CVS and Walmart, as well as online pharmacies. Whereas the test marketed to health-care professionals costs about $17.50, Orasure expects the consumer version to sell for more. The company is not announcing a price yet, but said it would be just under $60.00. CEO Doug Michels said the additional cost to the consumer will help pay for a toll-free call center to provide counseling and medical referrals to test users.

This approval represents $500 - $750 Million in revenue per year

This article has been condensed in the interest of space. The article can be found in its entirety here. www.usatoday.com

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25108 Marguerite Parkway, Suite A260 • Mission Viejo, Ca. 92692 • Tel: (949) 367‐1191  | Fax: (949) 367‐1022 

Finally, the FDA has realized the necessity for the public to be able to purchase an Over The Counter (OTC) HIV test that can be used in the privacy of their homes. Rather than scheduling an appointment with a doctor or a laboratory, the public now has an opportunity to purchase an at-home HIV test that delivers same-day results significantly cheaper than a doctor or a laboratory visit and most importantly, no needle.

The biggest challenge LifeSaver faces is educating the public when it comes to saliva-based testing. This FDA approval brings creditability and awareness to the benefits of saliva-based testing. OraSure's approval by the FDA solves this

issue for LifeSaver. OraQuick’s test is poised to generate massive exposure for saliva-based testing and profits.

The estimated market for these tests in the US is between $500 and $750 million dollars per year. OraSure will initially control this market (this is the only saliva-based HIV test available) with their product until the launch of LifeSaver’s HIV Stik®.

Upon release of the LifeSaver HIV Stik®, the public will quickly become aware of its superiority in every category including accuracy, ease of use and price! Please see the comparisons below.

 

A Brief Comparison of OraQuick and LifeSaver

                  LifeSaver HIV Stik® Advantages  

LifeSaver has simple, easy-to-use instructions featuring a (+) or (-) sign that virtually anyone can understand.

LifeSaver has a faster collection rate (seconds vs. 2

full minutes for OraQuick). LifeSaver is not compromised by food or liquids in

the mouth and there is no wait time.

A small amount of saliva is all that is necessary

“As easy as licking a stamp”

LifeSaver has a faster read time (2 minutes vs. 20- 40 minutes). LifeSaver is $7.00 vs. $17.50 to health care

professionals. LifeSaver guarantees accurate results.

LifeSaver is the only test that positively verifies the collection of the sample and that the test has been completed correctly.

LifeSaver has superior packaging and higher resistance to humidity and heat up to 1000 F, making it better equipped for shipping and storage both on a shelf and at home.

LifeSaver guarantees 2 years shelf life.

            OraQuick Advance HIV Shortcomings 

 

OraQuick HIV Test instructions are lengthy, complex and difficult to understand.

OraQuick Requires 2 full minutes of swabbing the month to collect the required amount of sampling.

OraQuick is sensitive to residues in the mouth. The subject must refrain from eating or drinking a minimum of 20 minutes before using the test.

OraQuick Requires 20-40 minutes of wait time for results.

OraQuick Test cost $17.50 to health care professionals and will cost just under $60.00 to the public.

OraQuick is only 92 % accurate when used by non-professionals according to the FDA.

OraQuick has a lower temperature tolerance of 790 F, requiring refrigeration in most cases and risks comprising reliability due to inadequate storage during delivery, on the shelf, or at the home.

OraQuick have less than one year of shelf life.

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25108 Marguerite Parkway, Suite A260 • Mission Viejo, Ca. 92692 • Tel: (949) 367‐1191  | Fax: (949) 367‐1022 

Directions for Using the LifeSaver HIV Stik®

A (+) or (‐) symbol appearing on the test pad indicates a Positive or Negative result  

that the test has been completed successfully. 

Step 1: Simply wipe the Stik® over the tongue. Step 2: Read the results in less than 2 minutes. If No Symbol appears, discard. LifeSaver’s HIV test is that simple to use.        

 

  

     NOT ACTIVATED If NO SYMBOL appears; the test was compromised and must be discarded.  

NEGATIVE READING If the Stik® DOES NOT DETECT the substance, a minus sign appears POSITIVE READING If the Stik® DETECTS the substance, a plus sign appears

LifeSaver’s HIV Stik® positively verifies that the test has been completed correctly,

Eliminating False Negatives

                                                       

Directions for Using the OraQuick HIV Test are listed in the following 5 pages.

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25108 Marguerite Parkway, Suite A260 • Mission Viejo, Ca. 92692 • Tel: (949) 367‐1191  | Fax: (949) 367‐1022 

These are the steps a consumer would need to precisely follow in order to use the OraQuick test.

OraQuick’s HIV Test: How To Use Instructions The administrator of this test should first instruct the subject about the test and how to collect an oral fluid sample for OraQuick Rapid HIV Test kit. Following which, the test device is then offered to the subject for the collection of the sample with reference to the guidelines following:

SET UP YOUR WORKSPACE

1. Gather the materials you will need. 2. Allow the test kit to come to operating temperature before

use. 3. Refer to the External Quality Control section in this

package insert to determine when the Kit Controls should be run.

4. Cover your workspace with a clean, disposable, absorbent workspace cover.

5. Set an OraQuick ADVANCE ® Reusable Test Stand (“Stand”) up on your workspace cover. Use only the stand provided.

6. Put on your disposable gloves as required in accordance with the Safety Precautions section in this package insert.

7. Prior to testing provide the “Subject Information” pamphlet to the person being tested.

 

 

GENERAL TEST PREPARATION FOR ORAQUICK RAPID HIV TEST:

1. Open the two chambers of the OraQuick Rapid HIV Test Kit Divided Pouch (“Pouch”) by tearing at the notches on the top of each side of the Pouch (see picture a and b ). To prevent contamination, leave the Test Device (“Device”) in the Pouch until you are ready to use it. 2. Remove the Developer Solution Vial (“Vial”) from the Pouch. Hold the Vial firmly in your hand. Carefully remove the cap from the Vial by gently rocking the cap back and forth while pulling it off. Set the cap on your workspace cover. 3. Slide the Vial into the top of one of the slots in the Stand. DO NOT force the vial into the Stand from the front of the slot as splashing may occur. Make sure the Vial is pushed all the way to the bottom of the slot in the stand (see picture c).

NOTE: DO NOT cover the two holes in the back of the Device with labels or other materials. Doing so may cause an Invalid result.

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25108 Marguerite Parkway, Suite A260 • Mission Viejo, Ca. 92692 • Tel: (949) 367‐1191  | Fax: (949) 367‐1022 

SPECIMEN COLLECTION AND TESTING PROCEDURE

The OraQuick ADVANCE ® Rapid HIV-1/2 Antibody Test can be used for testing oral fluid. Refer to the specific testing procedure below.

ORAL FLUID PROCEDURE

STEP 1: COLLECT

1. Ensure prior to testing that the subject has not had anything to eat, drink or has chewed gum for at least 15 minutes. Have the subject wait for at least 30 minutes prior to testing if they have used any oral care products.

2. Have the person being tested remove the Device from its Pouch. DO

NOT allow the person to touch the Flat Pad (see picture 1A). Check to make sure that an Absorbent Packet is included with the Device (see picture 2A). If no Absorbent Packet is present, discard the Device and obtain a new Pouch for testing.

3. Direct the person to place the Flat Pad above the teeth against the

outer gum. Direct the person to gently swab completely around the outer gums, both upper and lower, one time around, using the Flat Pad (see pictures 3A and 4A) for 2 minutes. DO NOT allow the person to swab the roof of the mouth, the inside of the cheek.

NOTE: Both sides of the Flat Pad may be used during this procedure.

STEP 2: TEST

1. Insert the Flat Pad of the Device all the way into the Vial (see picture 5A). Make sure that the Flat Pad touches the bottom of the Vial. The Result Window on the Device should be facing towards you (see picture 6A).

2. Start timing the test (see picture 7A). DO NOT

remove the Device from the Vial while the test is running. Pink fluid will appear and travel up the Result Window. The pink fluid will gradually disappear as the test develops (see picture 8A).

Read the results after 20 minutes - 40 minutes in a fully lighted area.

3. Refer to the Test Result and Interpretation of

Test Result section in this package insert.

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25108 Marguerite Parkway, Suite A260 • Mission Viejo, Ca. 92692 • Tel: (949) 367‐1191  | Fax: (949) 367‐1022 

If you are frustrated with the complicated instructions for the OraQuick HIV test, go back to page 3 and read the two simple steps for the LifeSaver test (There are additional OraQuick steps still to follow). Now you will have a better understanding of why the OraQuick has so many false negative results. Unfortunately, people will get frustrated with the OraQuick instructions and steps required, taking short cuts resulting in false negatives.

 

QUALITY CONTROL

A control lone in the “C” area of the result area indicates a valid result. A valid result indicates that a suitable sample was collected and that the test functioned properly. The control line will appear on all valid tests, whether or not the result is negative. Kit Control: Re-agents are available separately (Cat No. RBL 308-C). These are used to verify adequate test performance. Kit controls should be run once per shift by the test administrator, and whenever changing to a different lot of tests. Refer to the kit control product insert when using these re-agents.

What does the lines on the OraQuick test indicators mean?

NON REACTIVE RESULTS: Only the control line appears If a single line appears on the test strip in the area adjacent to the triangle labeled “C”, the result is non-reactive. This suggests the absence of anti HIV antibodies in the specimen.

Note: Using the Negative Kit Control gives thus result (see insert for OraQuick HIV 1/2 Kit Controls)

REACTIVE RESULTS: Two lines appear If two lines appear on the test strip, adjacent to the triangles labeled “T” and “C” triangles respectively, the result is considered to be reactive. This suggests the presence of anti HIV antibodies in the specimen. One of the lines may be darker than the other.

Note: Using the HIV-1 Kit Control or HIV-2 Kit control results in a dark line adjacent to the triangle marked “C” and a faint line adjacent to the triangle marked “T”.

INVALID: No line present in the “C” area of window. If there is no line in the area marked “C”, the result is invalid. An invalid test should be repeated with a new test device. If an invalid test is obtained with an oral fluid specimen, use a blood test procedure for repeat testing.

LifeSaver HIV Stiks® are simple to use, (as easy as licking a stamp), with easy to read instructions, forensic quality results in 2 minutes and costs a fraction of the OraQuick test.

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25108 Marguerite Parkway, Suite A260 • Mission Viejo, Ca. 92692 • Tel: (949) 367‐1191  | Fax: (949) 367‐1022 

A Visual Comparison of the two products, starting with the LifeSaver HIV Stik®

 

A (+) or (‐) symbol appearing on the test pad indicates a Positive or Negative result  

that the test has been completed successfully. 

With the market established and the public awareness of the product initiated, LifeSaver’s HIV Stik® will quickly dominate the competition with its ease of use, superior packaging/shelf life and clinical accuracy. LifeSaver’s lower price for its HIV test will also appeal to consumers, which will be far below what OraSure will charge.

OraQuick’s accuracy falls well below 100% (92% according to the FDA report). The test involves complicated instructions that, if not followed correctly, can lead to inaccurate readings. A consumer may take the test and be less than confident, or unsure of the results.

Lifesaver does not believe that there is any room for error.

Having the legwork of public awareness done, LifeSaver’s superior product will easily enter the market and surpass OraSure to become the global leader in saliva-based HIV testing.

See the following page for the OraQuick Advance HIV-1/2 steps. 

                                                                  

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25108 Marguerite Parkway, Suite A260 • Mission Viejo, Ca. 92692 • Tel: (949) 367‐1191  | Fax: (949) 367‐1022 

 

 

Now that you have reviewed the information for both tests,

Which product would you choose?

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• 25108 Marguerite Parkway, Suite A260 • Mission Viejo, Ca. 92692 • Tel: (949) 367‐1191 Fax: (949) 367‐1022 •  

  

The Looming American Red Cross Crisis and the LifeSaver Solution

Most Americans view the American Red Cross (ARC) as their safety net; a venerable institution ready to serve citizens in time of need. Whether it’s a terrorist attack or a natural disaster, the ARC is trusted to deliver clean, safe blood wherever and whenever it is needed.

In truth, the ARC’s blood may not be nearly as safe as people think. Although not well known, more than a dozen reports have been filed by the U.S. Food and Drug Administration (FDA) against the ARC for poor quality control standards which have placed people at risk for contracting life-threatening diseases such as AIDS and hepatitis. For over fifteen years, U.S. federal courts have been demanding that the ARC improve its standards. In the last few years, courts have imposed over $47 million in fines for the ARC's failure to comply. Worse still, since the ARC refuses to investigate or even record these mistakes, there is no way of identifying or keeping track of how many people have been infected by contaminated blood. This situation has grown so serious that the FDA has recently threatened the ARC with criminal charges if it does not rectify the situation.

No one wants to resolve this matter more than the ARC, but the problem is so deep and widespread throughout the organization that it is powerless to stop it. Currently, the only existing method to screen a potential donor is by filling out a complicated and lengthy questionnaire, leading to an interview with a technician. Unfortunately, the ARC has no way to accurately test donors or verify eligibility before blood is drawn. All blood collection and distribution requires multiple steps involving numerous departments and personnel, injecting the possibility of errors into the system and making the source of the problem costly and nearly impossible to identify. A step-by-step walk through of the blood collection process shows why it is so difficult to correct in its current form.

Steps and costs of the blood draw process:

1. The applicant donor fills out paperwork.

2. The potential donor is then asked a series of questions by the technician.

3. If the donor answers the questions satisfactorily, he/she is then taken into a blood draw room where another technician draws the blood.

4. The technician packages the blood, which is then shipped to a different facility where it is unpacked and logged in for examination and analysis.

5. Another technician then analyzes the blood via enzyme analysis to determine its usability.

6. Finally, if the blood tests positive for contamination, it must be destroyed. In addition to the costs incurred for all of the steps described above, contaminated blood is considered Hazardous Waste material and is very costly to dispose of.

     

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• 25108 Marguerite Parkway, Suite A260 • Mission Viejo, Ca. 92692 • Tel: (949) 367‐1191 Fax: (949) 367‐1022 •   

  

This long, error-prone chain of events is causing the ARC so many headaches that it has reached a point where these costs are now threatening the organization’s very existence. In 2009, the ARC generated $2.1 billion in sales of blood and a net profit of $38.7 million. Last year alone the ARC threw away over $200 million (that they will admit to) worth of contaminated blood - an amount equal to five times its 2009 profit!

LifeSaver’s approach to the American Red Cross is a simple solution designed to deliver safer blood to the public and eliminate much of this waste. Upon entering the facility, each potential blood donor would be required to swipe a LifeSaver Stik® across their tongue. Within two minutes, the results are known and the risk of collecting contaminated blood is eliminated.

By employing LifeSaver’s Stiks® to pre-screen its blood donors, the American Red Cross stands to cut tens of millions of dollars in waste while simultaneously complying with government regulations. All of the ARC and its affiliates would adopt the LifeSaver Solution. At a price of $7.00 per test, it would save the ARC at least $150 million annually and boost its profits by a minimum of 250%, if not more.

For LifeSaver, this one account (ARC) would generate over $60 million in sales annually (in the US only). Even though the ARC is the largest blood collection service in the United States, it still accounts for only 43% of America’s total blood draws. Assuming 25% of the remaining blood collection services in the U.S. adopted this program, (All of the ARC and its affiliates would have to adopt the LifeSaver Solution because they share the same problems), LifeSaver’s domestic sales for this one sector alone would approach $80 million annually (in the US only) - over twice its projected revenues for the first year of operation.

In addition to potential sales from domestic clients, there are 185 International Federation of Red Cross and Red Crescent Societies in other countries around the world. Once the non-affiliated blood collection agencies in those countries are accounted for as well made aware of the LifeSaver Solution, the enormous need for LifeSaver’s products and the equally sizeable returns these sales would bring become irrefutable.

“Saving Precious Lives”

                       

Page 15: LifeSaver Information Documents

• 25108 Marguerite Parkway, Suite A260 • Mission Viejo, Ca. 92692 • Tel: (949) 367‐1191 Fax: (949) 367‐1022 •   

The costs to “The American Red Cross”

from contaminated blood Cost to the American Red Cross

$47 million in fines from U.S. Federal Courts.

Threats of criminal charges being brought against the ARC by the FDA (Federal Food and Drug Administration).

$200 million in contaminated blood units thrown away each year - five times its 2009 profit of

$38.7 million! Costs to the Blood Recipient

The risk of contracting infectious diseases, such as AIDS and hepatitis due to contaminated blood. (Actual number of cases & costs are undetermined because the American Red Cross does not record or investigate its mistakes.)

Estimated cost savings to The American Red Cross Using LifeSaver’s Stiks® based on $200 million in contaminated blood and $47 million in fines a

minimum of $200 million.

Total Market Size

ARC’s percentage of the Total U. S. blood collection industry: 43%

Other U.S. blood collection agencies: 57%

Total number of International Federation of Red Cross and Red Crescent Societies in countries around the word: 186

U.S. population as a percent of the world population: 4.4%

LifeSaver’s projected annual sales based on percent of market capture:

American Red Cross: $60 million

Other U.S. blood collection services: $20 million

Total worldwide Red Cross / Red Crescent agencies

+ Non-affiliated agencies. Just 10% of these facilities $181 Million 

   

Page 16: LifeSaver Information Documents

 

Corporate Office

Ttest USA, Inc.

25108 Marguerite Parkway, Suite A-260 Mission Viejo, CA 92692

Ted Titmus

Chairman/Founder

Phone: (949) 367 – 1191 Direct Fax: (949) 367 – 1022

E mail: [email protected]

Website: www.alifesaver.com