Quotient banks on biodiagnostics

Jan. 1, 2010

While many laboratories have told us that they are desperate for another supplier, blood bankers are by definition a careful and conservative group. This deliberateness results in some inertia actually to evaluate new suppliers.

Edited by Carren Bersch, Editor

This month, MLO is pleased to introduce to its
International Corner Mick Hannan, vice president of Marketing, at
Quotient Biodiagnostics, headquartered in Newtown, PA. Mr. Hannan
answers several questions about Quotient Biodiagnostics' global
activities that are sure to interest readers.

MLO: While there is much being made by many
organizations that “global” is a relatively new way of doing business, it
appears that Quotient Biodiagnostics has been global since its inception, by
virtue of its R&D and operations arm, Alba Bioscience, conducting business
commercially worldwide. Your website mentions that Alba, was originally
established in Scotland in the 1940s to manufacture blood-typing reagents
but has grown to serve not only the U.K. market but markets worldwide,
mostly on an OEM basis. So, Quotient Biodiagnostics is now moving into
America, to serve customers directly, is that correct?

Hannan: Alba Bioscience, originally part of the
Scottish National Blood Transfusion Service, was privatized and subsequently
purchased by Quotient in 2007. Alba, for much of its existence both as a
public and private entity, has been operating solely as a global original
equipment manufacturer (OEM), manufacturing and developing products for
major transfusion companies that were sold under those companies' labels in
more than 30 countries throughout North America, Europe, and Asia. In 2007,
Alba was purchased by the U.K.-based company Quotient Bioscience, which in
early 2009 reorganized into two distinct businesses: 1) Quotient
Bioresearch, which is a contract research organization focused on drug
development — everything from lead optimization to late-phase clinical
trials and sports medicine, primarily drug testing for the horse- and
dog-racing industries. 2) Quotient Biodiagnostics, which is the transfusion
diagnostics division, of which Alba is the manufacturing and R&D arm, and
'Quotient Biodignostics' is the name to our end-user customers. Quotient
Biodiagnostics' president and CEO, Jeremy Stackawitz, is located in the U.S.
but, as you would imagine, spends quite a bit of time in the U.K.

MLO: With the announcement of the formation of
Quotient Biodiagnostics, we are, of course, interested in your varied
products and how those affect all things “medical laboratory.” Can you tell
us when you were FDA-licensed and began to provide products for the American
marketplace? Your April 7, 2009, press release indicated that you expect to
expand your existing range of products over the next 12 to 18 months —
almost a year has passed since that announcement. Can you tell our American
readers exactly what products they could expect to purchase from Quotient
Biodiagnostics presently and in the near future? Have many American labs
been introduced to Quotient Biodiagnostics' products in this last year and,
if so, what is the feedback you are getting from them in terms of
performance, and results.

Hannan: Quotient Biodiagnostics received Food and
Drug Administration (FDA) approval on Oct. 16, 2009, for its first Biologics
License Application (BLA) covering 15 monoclonal antibodies for use as blood
typing reagents. These ALBAclone products include seven antisera for ABORh
blood typing as well as eight products for typing rare antigens. Quotient
also has some enhancement media and control products approved via 510k, as
well as two specialty products. One is the ALBAclone Advanced Partial RhD
Typing kit, for identifying weak and partial D variants — this is a product
most likely to be used in the reference laboratory setting. The second is
the Quant-Rho FITC Anti-D product for quantifying fetomaternal bleeding via
flow cytometry to establish the proper dosage for Rh immune globulin.
Quotient has nearly 40 additional products in various stages of review at
the FDA. These include red cell products (reverse typing, antibody screens,
and panels), anti-human globulin, and a number of additional rare polyclonal
and monoclonal antisera. We expect the full portfolio to be available by the
end of 2010.

MLO: Have the same products you are offering in the
USA been available in Europe and in other countries through Alba or
Quotient, or are those totally different types of products than the ones you
have introduced in America? Can you describe what your Evaluation Program
means for a potential customer?

Hannan: Almost all products have been on the market
already in Europe or elsewhere for several years, either under the Alba
Bioscience or one of the other major transfusion companies' labels. There
may have been some slight variations made for the U.S. market in
formulation, instructions for use, name, etc. Our Evaluation Program has
been established to allow interested laboratories to try out our product vs.
their current suppliers' risk-free, and with minimal hassle. We will provide
the ALBAclone products to laboratories to evaluate. If, as we expect, the
product meets specifications, we would expect to receive an order,
especially given our very competitive prices. If, for whatever reason, the
lab does not want the product, it can simply return the product at no
charge. In addition, as much of the time and effort of doing an evaluation
is the thinking and set-up time of the protocol and how exactly the
evaluation will be conducted, our technical director — who has 20 years
experience with a hospital laboratory and 15 more years in quality and
compliance with the American Red Cross — created a starting-point protocol
to help meet the needs of most labs. She is also available through our
Technical Service line to help walk laboratories through the process, as
needed, in addition to full product support, if and when labs begin to use
them regularly.

MLO: In terms of the types of products, are the needs
of medical laboratories in other countries different from those in the
United States? In developing countries, are there perhaps one or two
products used more frequently than those used in Europe or in America? Do
you use different marketing techniques for each region or for each country
when you begin to distribute your products?

Hannan: Transfusion diagnostics needs are essentially
the same throughout the world — to provide reliably safe transfusions to
customers. There are some geographical variations, however, with regard to
the frequency of certain antigens and antibodies as well as levels of
automation. Also, pricing is highly variable. Our product line is primarily
aimed at laboratories that do substantial manual typing and screening,
either as their primary means of diagnosis or as backup to an automated
system to clarify discrepant or unusual results. This means that in many
cases our products are more relevant in the U.S. vs. our home market of
Europe, because Europe is a much more automated market, whereas 60% to 70%
of the U.S. market is manual. This has much to do with the decentralized
nature of U.S. demographics vs. Europe where medical care is much more
centralized in large centers.

Another area where our European heritage may be an
advantage is in the area of D antigen detection. The European market for
historical reasons has been much more focused on the detection of various
weak and partial D variants than the U.S. That, however, is changing, and we
provide a product line that is specialized in this area.

We have four anti-sera to detect D antigen, including the
world's only monoclonal antibody that detects the DVI variant through direct
agglutination. We also have the ALBAclone Advanced Partial RhD Typing kit
that identifies partial RhD types, generally giving comparable results to
molecular analysis at a fraction of the cost. Finally, we have the Quant-Rho
FITC Anti-D product which quantifies fetomaternal hemorrhage by in vitro
labeling of RhD positive cells for analysis by flow cytometry, allowing
better dosing decisions for Rh immune globulin.

Our marketing approach in the U.S. is also different.
This is actually our second time launching our ALBAclone products here in
the U.S. Originally, Alba tried to apply a European strategy in the U.S. by
commercializing through an agent. That did not gain much traction, as the
U.S. medical community demands more on-hand infrastructure and support than
that method could provide. As a result, we regrouped, and with the approval
of this first set of products, we are building our own direct infrastructure
here, complete with a direct sales force and dedicated technical and
customer service. The focus of our marketing is to emphasize the quality of
our products — given our years of experience and the fact that we are the
second largest manufacturer of blood-banking monoclonal antibodies in the
world; emphasize our focus on customer service — which we believe has been
lacking in the U.S. market — and a competitive price. As mentioned, outside
the U.S. and the U.K., we are primarily an OEM supplier to other transfusion
diagnostics companies that would be in charge of commercialization.

MLO: What challenges do Quotient Biodiagnostics'
representatives overseas face personally and professionally as part of the
organization's global outreach? What challenges did/does the organization
face in developing its global business? Of all the details that one must
confront in mastering global outreach, what are the “Top 3” suggestions you
would give a newly minted Quotient Biodiagnostics' employee who was pursuing
the American arm of the business?

Hannan: Because our business outside the U.S. and
U.K. is primarily as an OEM supplier, we do not have a direct sales force in
those regions. Our challenges in coming to the U.S. are that the market has
essentially been divided between two or three companies for a long time.
While many laboratories have told us that they are desperate for another
supplier, blood bankers are by definition a careful and conservative group.
This deliberateness results in some inertia to evaluate new suppliers.

We have to be sure that:

  • 1. laboratories are knowledgeable of our years of
    experience manufacturing and developing products;
  • 2. we as a company ensure that we are always thinking
    about how can we provide superior customer service; and
  • 3. we demonstrate the value we can bring to a

Then we simply to provide tools that enable laboratories
to evaluate our products as quickly and easily
as possible.

Learn more about Quotient Biodiagnostics at