Advice Pool - Health and Fitness

Verifying the presence of HIV antibodies is a rigorous clinical process. Although many home HIV test kits do some form

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

of verification of the antibodies, they are way less accurate than the FDA approved tests. A false positive can cause u

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ndue mental anguish and lead to irrational decisions based upon inaccurate information. However, a false negative would

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

be much worse. Imagine someone thinking they do not have HIV and continuing with unprotected sexual activities?

In re

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

lity, home test kits that provide false negatives would be inadvertently leading to the spread of the disease! How awfu

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

l is that?

What does it take to get approved?

Gaining FDA approval requires rigorous testing. Not only does the test

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

require accuracy, it requires repeatability. This means that the test must show the presence of HIV antibodies when the

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

do exist and not show the presence of HIV antibodies when they do not exist with an extremely high degree of accuracy.

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

If it is not accurate, the reasons why must be known – for example – perhaps the HIV antibodies do not show up for a ce

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

rtain amount of time after infection and the test is taken within that time. The absence of antibodies could contribute

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

to a false negative. When these causes are known, they become disclaimers on the testing kit so that doctors can best c

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ounsel patients on what action to take.

The repeatability is essential to FDA approval. This means that no matter how

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

many times the test is taken or the type of person that takes the test, the results are still accurate. So – no matter

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

if you’re a man or a woman (or any other attribute), the test results still have the same high degree of accuracy.

Othe

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

labs have verified results – is that good enough?

Unfortunately, other laboratory results may not be good enough. If

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

they were good enough, then why shouldn’t the results be should be submitted to the FDA for approval? If a laboratory i

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

s unethical or run improperly, then they might consider a limited group of 80% accuracy good enough. But – for those of

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

us who rely on the results of the test to understand what changes might occur in our lives, 80% with a small handful of

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

hand-picked individuals isn’t good enough.

Bottom line – when it comes to home HIV test kits, the wise course of action

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

is to ensure that the home kit has the FDA seal of approval. Otherwise, a clinic, a hospital or doctors office is best

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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