Allegro Diagnostics Receives $2.8 Million SBIR Grant from National Cancer Institute

Allegro Diagnostics Receives $2.8 Million SBIR Grant from National Cancer
Institute
Grant Will Support Clinical Development of BronchoGen(TM), Other Allegro
Products

BOSTON, Oct. 22 /PRNewswire/ -- Allegro Diagnostics, a leader in the field of
molecular diagnostics for lung cancer, has announced that its clinical study
for BronchoGen(TM), a diagnostic test for patients suspected of having lung
cancer, will receive up to $2.8 million in funding for a Phase I/II Fast Track
Small Business Innovation Research (SBIR) grant from the National Cancer
Institute (NCI). This groundbreaking clinical study is enrolling up to 800
patients at 12 sites in the U.S. If successful, BronchoGen(TM) would be a
first in class, novel test in an area of significant unmet medical need.

"Bravo to Allegro Diagnostics," said Laurie Fenton Ambrose, President & CEO of
Lung Cancer Alliance (LCA), the only national organization providing patient
support and advocacy solely to those living with or at risk for the disease,
"for making earlier, more accurate diagnosis of suspected lung cancer a
research a priority. It is our hope that this trial will prove successful and
ultimately bring important benefits to both doctors and patients - something
long overdue. We look forward to closely monitoring the progress of this
research and team of world class leaders."

"The elegant technology developed by Allegro scientists could be a very
valuable piece of our quest to diagnose lung cancer as early and accurately as
possible, and in a cost effective manner. I look forward to the study,"
commented Steve Shapiro, MD, Professor and Chairman of the Department of
Medicine at University of Pittsburgh.

BronchoGen(TM) uses easily accessible cells lining the airway (bronchial
epithelial cells) obtained during bronchoscopy and analyzes their RNA to
measure gene expression levels. Allegro's scientific team has found that
specific sets of genes are over- and under-expressed in current or former
smokers with lung cancer as compared to those without lung cancer. This
finding was validated in a 164 patient study published in Nature Medicine in
March, 2007. Importantly, the BronchoGen(TM) approach does not require an
actual tissue sample from a suspicious nodule or lesion, which often must be
accessed through highly invasive procedures that pose significant risks to the
patient.

Bronchoscopy is one of the most common diagnostic modalities used to assess
patients for suspicion of lung cancer. Performed over 300,000 times a year in
the U.S. in such patients, bronchoscopy has relatively low sensitivity for
detecting disease in those patients who have it, leading to a high number of
false negative results. Guidelines from the American College of Chest
Physicians state that when a bronchoscopy is non-diagnostic or negative and
suspicion of lung cancer remains, a clinician should pursue additional
diagnostic procedures to assess the patient's status.

"The NCI support for our trial is highly encouraging news for current or
former smokers at risk for lung cancer, and will propel the development of
BronchoGen(TM). It will also help Allegro Diagnostics extend its scientific
platform into other areas," said Dan Rippy, President & CEO of Allegro. "Lung
cancer patients generally have a very poor prognosis because most are
diagnosed with late stage disease. BronchoGen(TM) may help clinicians to
detect disease earlier and reduce unnecessary medical procedures in those
patients who do not have lung cancer."

"The NCI grant recognizes the importance of developing new and innovative
approaches to the diagnosis and treatment of lung cancer," said Jerome Brody,
MD, chief scientific officer, co-founder of Allegro Diagnostics and an author
on the Nature Medicine study. "The grant will accelerate Allegro Diagnostics'
current clinical trial aimed at validating BronchoGen as an early lung cancer
diagnostic tool and will assist in developing a series of additional genomic
tests that could help lessen the human toll of the leading cause of cancer
death in the US and the world."

"This test could be a real breakthrough," said Frank Hull, MD, of Broward
Health in Fort Lauderdale, Florida. "My patients are very anxious once they
are told they have a lung nodule that could be cancer. Particularly in small
lung nodules below the resolution of PET scanning and difficult to accurately
biopsy, this test could result in earlier treatment in patients with lung
cancer. In patients with benign nodules this could save two years of anxiety,
which is the usual time period that we follow these lung nodules with serial
imaging before we ascertain them as benign."

"The development of technologies that can aid in the accurate diagnosis of
lung cancer based on analysis of (bronchial) samples is likely to result in
less discomfort to patients and may help bring down costs associated with
diagnostic testing," said Ali Andalibi, Ph.D., Program Director with the
National Cancer Institute.

About Lung Cancer

According to the American Cancer Society, more than 220,000 new cases of lung
cancer are diagnosed each year in the U.S., and more than 150,000 deaths occur
annually from the disease. Lung cancer is the leading cause of cancer death in
the industrialized world, responsible for more than 1.3 million deaths per
year worldwide. In the U.S., lung cancer kills more people than colon, breast,
prostate, and ovarian cancers combined. While lung cancer can be cured by
surgery if caught in the early stages, 65-80% of lung cancer patients present
with late stage disease. The five-year survival rate for lung cancer patients
is roughly 15%, a rate that has remained unchanged for several decades.

About Allegro Diagnostics

Allegro Diagnostics was founded in 2006 to develop and commercialize molecular
diagnostics in lung cancer and other pulmonary diseases using proprietary gene
expression technology originating within the Pulmonary Center at the Boston
University School of Medicine. The company's initial focus is on earlier
stage, more accurate diagnosis of suspected lung cancer. Allegro Diagnostics
is privately funded by Kodiak Venture Partners, Catalyst Health Ventures, and
Boston University. For more information, visit the website of Allegro
Diagnostics at: www.allegrodx.com.

About Kodiak Venture Partners

Founded in 1999, Kodiak manages three funds totaling $676M and targets
companies in North America. Kodiak focuses on seed and early stage investments
in emerging communications/wireless, semiconductor/equipment,
software/services, internet/new media, and life technology companies. Kodiak's
partners are successful high-technology business entrepreneurs who take a
hands-on approach to building market leaders. Previous Kodiak investments have
included ALIS Corporation, Fluxion Biosciences, and Groove Mobile. For more
information on Kodiak Venture Partners, visit: www.kodiakvp.com.

About Catalyst Health Ventures

Catalyst Health Ventures is an early-stage venture capital firm targeting
technology solutions applied within the health care and life science
industries. At the core of its strategy is a committed, hands-on approach to
working with management and syndicate partners to build successful companies.
Catalyst's disciplined investment process leverages both intellectual and
financial capital to originate deals, cultivate opportunities, and realize the
full potential of emerging ventures in the health care and life science
marketplace. For more information on Catalyst Health Ventures, visit:
www.catalysthealthventures.com.

SOURCE Allegro Diagnostics

Kate Porta, Allegro Diagnostics, Inc., +1-617-414-2337