Last-minute holiday shopping bags OncoDiagnotics for Predictive Biosciences

LEXINGTON, Mass.—Predictive Biosciences did a littlelast-minute holiday shopping in December, closing a deal to acquireCleveland-based OncoDiagnostic Laboratory (ODL), a private pathology laboratorythrough which the company will commercialize its proprietary non-invasive,molecular cancer diagnostic assays.

Predictive aims to fill an unmet medical need fornon-invasive, less expensive and highly reliable cancer screening tests,utilizing molecular biomarkers detected in urine samples and its novel technology.ODL's expertise in urology complements and furthers this strategic goal.Financial terms of the agreement were not disclosed.

The acquisition of ODL represents a step in Predictive'sbusiness plan, whereby it absorbs an established commercial operation andbegins to launch commercially its high-performance assays for improved cancermanagement. Predictive Biosciences was launched in 2006 and is privately fundedby Flybridge Capital Partners, Highland Capital Partners, Kaiser PermanenteVentures and New Enterprise Associates. The company's first assays are designedto detect urinary biomarkers fundamentally associated with the physiologicalchanges resulting from cancer development and progression. The initial focusfor these tests will be the growing cancer survivor population and the largenumber of individuals undergoing clinical workups for cancer.

Predictive is the first company to combine both protein andDNA biomarkers to maximize single assay performance, resulting in both highnegative predictive values (NPV) and high positive predictive values (PPV), forthe absence or presence of cancer, respectively. If adopted widely, the newtest would supplant more invasive screenings. Ultimately, the goal is forphysicians to use Predictive's test prior to invasive procedures such ascystoscopy and colonoscopy.

The first in Predictive's portfolio of non-invasive assaysis a urine-biomarker based test for the detection of bladder cancer, which thecompany plans to market this year. In addition, and based on the broadapplicability of Predictive's technology, ODL will also support subsequentmarket launches for additional portfolio products, including prostate andbreast cancer assays.

ODL is a Clinical Laboratory Improvement Act(CLIA)-certified anatomic pathology and molecular diagnostics lab that servesurologists, gastroenterologists, dermatologists, gynecologists and othersubspecialty physicians across the United States. It was launched in 1985 toserve a growing need for office-based urologists and other subspecialtyphysicians.

Before the acquisition, ODL had in place a U.S. salespresence and research strength at its Cleveland base. The combined company willtotal approximately 80 employees between Lexington and Cleveland. Each companywill remain in its current location.

Predictive Vice President for Business Development andCo-Founder Eugene Chiu says the combined company plans to grow its sales forceeven further, and will be "selectively adding" research and developmentexpertise to both locations this year.

According to Chiu, ODL was not looking to be acquired.Predictive, he says, "conducted a broad and extensive survey of the marketplaceto find a partner in the urology market."

"It was a strategic move for us," Chiu says. "We are excitedby the combination."

He said that the acquisition combines Predictive's expertisein the measurement of the absence or presence of cancer, and that adding thenovel subspecialty that ODL has developed in urology brings together twocompanies with similar cultures and strategic focuses.

"Now all the pieces are in place," Chiu continues. "Webelieve we have cracked the code for building a successful molecular biologycompany."

While Predictive gets scientific expertise and a web ofsales professionals, ODL becomes a part of a 24-year-old venture that boasts agrowing portfolio of novel cancer diagnostic assays that can help urologistsconfidently identify a patient's risk for cancer in a non-invasive, relativelysimple and reliable manner. According to Chiu, ODL will not change its name,rather, it will be known as a "division of Predictive Biosciences."

ODL representatives declined comment on the deal. Founded in1985 by Drs. Cirilo Galang, Paul Johenning and John Maksem, ODL introduced thetransrectal FNA biopsy of the prostate utilizing liquid phase fixation. ODL'spathologists, in collaboration with Dr. Donald Gleason, developed the Gleasongrading of prostate cancer using the FNA technique. The company also developeda proprietary non-carcinogenic fixative, OncoFix II, which allows for dualhistological and cytological examination of prostate biopsies.